42 U.S.C. § 263b — Certification of mammography facilities

Page 488 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 263a–6 (Pub. L. 102–493, § 6, Oct. 24, 1992, 106 Stat. 3151.) Editorial Notes CODIFICATION Section was enacted as part of the Fertility Clinic Success Rate and Certification Act of 1992, and not as part of the Public Health Service Act which comprises this chapter. Statutory Notes and Related Subsidiaries CHANGE OF NAME Centers for Disease Control changed to Centers for Disease Control and Prevention by Pub. L. 102–531, title III, § 312, Oct. 27, 1992, 106 Stat. 3504. EFFECTIVE DATE Section effective upon expiration of 2 years after Oct. 24, 1992, see section 9 of Pub. L. 102–493, set out as a note under section 263a–1 of this title. § 263a–6. Fees The Secretary may require the payment of fees for the purpose of, and in an amount suffi- cient to cover the cost of, administering sec- tions 263a–1 to 263a–7 of this title. A State oper- ating a program under section 263a–2 of this title may require the payment of fees for the purpose of, and in an amount sufficient to cover the costs of, administering its program. (Pub. L. 102–493, § 7, Oct. 24, 1992, 106 Stat. 3151.) Editorial Notes REFERENCES IN TEXT Sections 263a–1 to 263a–7 of this title, referred to in text, was in the original ‘‘this Act’’, meaning Pub. L. 102–493, Oct. 24, 1992, 106 Stat. 3146, known as the Fer- tility Clinic Success Rate and Certification Act of 1992, which enacted sections 263a–1 to 263a–7 of this title and provisions set out as notes under sections 201 and 263a–1 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 201 of this title and Tables. CODIFICATION Section was enacted as part of the Fertility Clinic Success Rate and Certification Act of 1992, and not as part of the Public Health Service Act which comprises this chapter. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective upon expiration of 2 years after Oct. 24, 1992, see section 9 of Pub. L. 102–493, set out as a note under section 263a–1 of this title. § 263a–7. Definitions For purposes of sections 263a–1 to 263a–7 of this title: (1) Assisted reproductive technology The term ‘‘assisted reproductive tech- nology’’ means all treatments or procedures which include the handling of human oocytes or embryos, including in vitro fertilization, gamete intrafallopian transfer, zygote intrafallopian transfer, and such other specific technologies as the Secretary may include in this definition, after making public any pro- posed definition in such manner as to facili- tate comment from any person (including any Federal or other public agency). (2) Embryo laboratory The term ‘‘embryo laboratory’’ means a fa- cility in which human oocytes are subject to assisted reproductive technology treatment or procedures based on manipulation of oocytes or embryos which are subject to implantation. (3) Secretary The term ‘‘Secretary’’ means the Secretary of Health and Human Services. (Pub. L. 102–493, § 8, Oct. 24, 1992, 106 Stat. 3151.) Editorial Notes REFERENCES IN TEXT Sections 263a–1 to 263a–7 of this title, referred to in text, was in the original ‘‘this Act’’, meaning Pub. L. 102–493, Oct. 24, 1992, 106 Stat. 3146, known as the Fer- tility Clinic Success Rate and Certification Act of 1992, which enacted sections 263a–1 to 263a–7 of this title and provisions set out as notes under sections 201 and 263a–1 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 201 of this title and Tables. CODIFICATION Section was enacted as part of the Fertility Clinic Success Rate and Certification Act of 1992, and not as part of the Public Health Service Act which comprises this chapter. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective upon expiration of 2 years after Oct. 24, 1992, see section 9 of Pub. L. 102–493, set out as a note under section 263a–1 of this title. SUBPART 3—MAMMOGRAPHY FACILITIES Editorial Notes PRIOR PROVISIONS A prior subpart 3 of part F of title III of the Public Health Service Act, comprising this subpart, was re- numbered subchapter C of chapter V of the Federal Food, Drug, and Cosmetic Act, by Pub. L. 101–629, § 19(a)(4), Nov. 28, 1990, 104 Stat. 4530, as amended by Pub. L. 103–80, § 4(a)(2), Aug. 13, 1993, 107 Stat. 779, and is classified to part C (§ 360hh et seq.) of subchapter V of chapter 9 of Title 21, Food and Drugs. § 263b. Certification of mammography facilities (a) Definitions As used in this section: (1) Accreditation body The term ‘‘accreditation body’’ means a body that has been approved by the Secretary under subsection (e)(1)(A) to accredit mam- mography facilities. (2) Certificate The term ‘‘certificate’’ means the certificate described in subsection (b)(1). (3) Facility (A) In general The term ‘‘facility’’ means a hospital, out- patient department, clinic, radiology prac- tice, or mobile unit, an office of a physician, Page 489 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 263b 1 So in original. Probably should be ‘‘paragraph’’. or other facility as determined by the Sec- retary, that conducts breast cancer screen- ing or diagnosis through mammography ac- tivities. Such term does not include a facil- ity of the Department of Veterans Affairs. (B) Activities For the purposes of this section, the ac- tivities of a facility include the operation of equipment to produce the mammogram, the processing of the film, the initial interpreta- tion of the mammogram and the viewing conditions for that interpretation. Where procedures such as the film processing, or the interpretation of the mammogram are performed in a location different from where the mammogram is performed, the facility performing the mammogram shall be respon- sible for meeting the quality standards de- scribed in subsection (f). (4) Inspection The term ‘‘inspection’’ means an onsite eval- uation of the facility by the Secretary, or State or local agency on behalf of the Sec- retary. (5) Mammogram The term ‘‘mammogram’’ means a radio- graphic image produced through mammog- raphy. (6) Mammography The term ‘‘mammography’’ means radiog- raphy of the breast. (7) Survey The term ‘‘survey’’ means an onsite physics consultation and evaluation performed by a medical physicist as described in subsection (f)(1)(E). (8) Review physician The term ‘‘review physician’’ means a physi- cian as prescribed by the Secretary under sub- section (f)(1)(D) who meets such additional re- quirements as may be established by an ac- creditation body under subsection (e) and ap- proved by the Secretary to review clinical im- ages under subsection (e)(1)(B)(i) on behalf of the accreditation body. (b) Certificate requirement (1) Certificate No facility may conduct an examination or procedure described in paragraph (2) involving mammography after October 1, 1994, unless the facility obtains— (A) a certificate or a temporary renewal certificate— (i) that is issued, and, if applicable, re- newed, by the Secretary in accordance with paragraphs 1 (1) or (2) of subsection (c); (ii) that is applicable to the examination or procedure to be conducted; and (iii) that is displayed prominently in such facility; or (B) a provisional certificate or a limited provisional certificate— (i) that is issued by the Secretary in ac- cordance with paragraphs (3) and (4) of subsection (c); (ii) that is applicable to the examination or procedure to be conducted; and (iii) that is displayed prominently in such facility. The reference to a certificate in this section includes a temporary renewal certificate, pro- visional certificate, or a limited provisional certificate. (2) Examination or procedure A facility shall obtain a certificate in order to— (A) operate radiological equipment that is used to image the breast; (B) provide for the interpretation of a mammogram produced by such equipment at the facility or under arrangements with a qualified individual at a facility different from where the mammography examination is performed; and (C) provide for the processing of film pro- duced by such equipment at the facility or under arrangements with a qualified indi- vidual at a facility different from where the mammography examination is performed. (c) Issuance and renewal of certificates (1) In general The Secretary may issue or renew a certifi- cate for a facility if the person or agent de- scribed in subsection (d)(1)(A) meets the appli- cable requirements of subsection (d)(1) with respect to the facility. The Secretary may issue or renew a certificate under this para- graph for not more than 3 years. (2) Temporary renewal certificate The Secretary may issue a temporary re- newal certificate, for a period of not to exceed 45 days, to a facility seeking reaccreditation if the accreditation body has issued an accredi- tation extension, for a period of not to exceed 45 days, for any of the following: (A) The facility has submitted the required materials to the accreditation body within the established time frames for the submis- sion of such materials but the accreditation body is unable to complete the reaccredita- tion process before the certification expires. (B) The facility has acquired additional or replacement equipment, or has had signifi- cant personnel changes or other unforeseen situations that have caused the facility to be unable to meet reaccreditation time- frames, but in the opinion of the accredita- tion body have not compromised the quality of mammography. (3) Limited provisional certificate The Secretary may, upon the request of an accreditation body, issue a limited provisional certificate to an entity to enable the entity to conduct examinations for educational pur- poses while an onsite visit from an accredita- tion body is in progress. Such certificate shall be valid only during the time the site visit team from the accreditation body is phys- ically in the facility, and in no case shall be valid for longer than 72 hours. The issuance of Page 490 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 263b a certificate under this paragraph, shall not preclude the entity from qualifying for a pro- visional certificate under paragraph (4). (4) Provisional certificate The Secretary may issue a provisional cer- tificate for an entity to enable the entity to qualify as a facility. The applicant for a provi- sional certificate shall meet the requirements of subsection (d)(1), except providing informa- tion required by clauses (iii) and (iv) of sub- section (d)(1)(A). A provisional certificate may be in effect no longer than 6 months from the date it is issued, except that it may be ex- tended once for a period of not more than 90 days if the owner, lessor, or agent of the facil- ity demonstrates to the Secretary that with- out such extension access to mammography in the geographic area served by the facility would be significantly reduced and if the owner, lessor, or agent of the facility will de- scribe in a report to the Secretary steps that will be taken to qualify the facility for certifi- cation under subsection (b)(1). (d) Application for certificate (1) Submission The Secretary may issue or renew a certifi- cate for a facility if— (A) the person who owns or leases the fa- cility or an authorized agent of the person, submits to the Secretary, in such form and manner as the Secretary shall prescribe, an application that contains at a minimum— (i) a description of the manufacturer, model, and type of each x-ray machine, image receptor, and processor operated in the performance of mammography by the facility; (ii) a description of the procedures cur- rently used to provide mammography at the facility, including— (I) the types of procedures performed and the number of such procedures per- formed in the prior 12 months; (II) the methodologies for mammog- raphy; and (III) the names and qualifications (edu- cational background, training, and expe- rience) of the personnel performing mammography and the physicians read- ing and interpreting the results from the procedures; (iii) proof of on-site survey by a qualified medical physicist as described in sub- section (f)(1)(E); and (iv) proof of accreditation in such man- ner as the Secretary shall prescribe; and (B) the person or agent submits to the Sec- retary— (i) a satisfactory assurance that the fa- cility will be operated in accordance with standards established by the Secretary under subsection (f) to assure the safety and accuracy of mammography; (ii) a satisfactory assurance that the fa- cility will— (I) permit inspections under subsection (g); (II) make such records and information available, and submit such reports, to the Secretary as the Secretary may re- quire; and (III) update the information submitted under subparagraph (A) or assurances submitted under this subparagraph on a timely basis as required by the Sec- retary; and (iii) such other information as the Sec- retary may require. An applicant shall not be required to provide in an application under subparagraph (A) any information which the applicant has supplied to the accreditation body which accredited the applicant, except as required by the Secretary. (2) Appeal If the Secretary denies an application for the certification of a facility submitted under paragraph (1)(A), the Secretary shall provide the owner or lessor of the facility or the agent of the owner or lessor who submitted such ap- plication— (A) a statement of the grounds on which the denial is based, and (B) an opportunity for an appeal in accord- ance with the procedures set forth in regula- tions of the Secretary published at part 498 of title 42, Code of Federal Regulations. (3) Effect of denial If the application for the certification of a facility is denied, the facility may not operate unless the denial of the application is over- turned at the conclusion of the administrative appeals process provided in the regulations re- ferred to in paragraph (2)(B). (e) Accreditation (1) Approval of accreditation bodies (A) In general The Secretary may approve a private non- profit organization or State agency to ac- credit facilities for purposes of subsection (d)(1)(A)(iv) if the accreditation body meets the standards for accreditation established by the Secretary as described in subpara- graph (B) and provides the assurances re- quired by subparagraph (C). (B) Standards The Secretary shall establish standards for accreditation bodies, including— (i) standards that require an accredita- tion body to perform— (I) a review of clinical images from each facility accredited by such body not less often than every 3 years which re- view will be made by qualified review physicians; and (II) a review of a random sample of clinical images from such facilities in each 3-year period beginning October 1, 1994, which review will be made by quali- fied review physicians; (ii) standards that prohibit individuals conducting the reviews described in clause (i) from maintaining any relationship to the facility undergoing review which would constitute a conflict of interest; (iii) standards that limit the imposition of fees for accreditation to reasonable amounts; Page 491 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 263b (iv) standards that require as a condition of accreditation that each facility undergo a survey at least annually by a medical physicist as described in subsection (f)(1)(E) to ensure that the facility meets the standards described in subparagraphs (A) and (B) of subsection (f)(1); (v) standards that require monitoring and evaluation of such survey, as pre- scribed by the Secretary; (vi) standards that are equal to stand- ards established under subsection (f) which are relevant to accreditation as deter- mined by the Secretary; and (vii) such additional standards as the Secretary may require. (C) Assurances The accrediting body shall provide the Secretary satisfactory assurances that the body will— (i) comply with the standards as de- scribed in subparagraph (B); (ii) comply with the requirements de- scribed in paragraph (4); (iii) submit to the Secretary the name of any facility for which the accreditation body denies, suspends, or revokes accredi- tation; (iv) notify the Secretary in a timely manner before the accreditation body changes the standards of the body; (v) notify each facility accredited by the accreditation body if the Secretary with- draws approval of the accreditation body under paragraph (2) in a timely manner; and (vi) provide such other additional infor- mation as the Secretary may require. (D) Regulations Not later than 9 months after October 27, 1992, the Secretary shall promulgate regula- tions under which the Secretary may ap- prove an accreditation body. (2) Withdrawal of approval (A) In general The Secretary shall promulgate regula- tions under which the Secretary may with- draw the approval of an accreditation body if the Secretary determines that the accredi- tation body does not meet the standards under subparagraph (B) of paragraph (1), the requirements of clauses (i) through (vi) of subparagraph (C) of paragraph (1), or the re- quirements of paragraph (4). (B) Effect of withdrawal If the Secretary withdraws the approval of an accreditation body under subparagraph (A), the certificate of any facility accredited by the body shall continue in effect until the expiration of a reasonable period, as deter- mined by the Secretary, for such facility to obtain another accreditation. (3) Accreditation To be accredited by an approved accredita- tion body a facility shall meet— (A) the standards described in paragraph (1)(B) which the Secretary determines are applicable to the facility, and (B) such other standards which the accred- itation body may require. (4) Compliance To ensure that facilities accredited by an ac- creditation body will continue to meet the standards of the accreditation body, the ac- creditation body shall— (A) make onsite visits on an annual basis of a sufficient number of the facilities ac- credited by the body to allow a reasonable estimate of the performance of the body; and (B) take such additional measures as the Secretary determines to be appropriate. Visits made under subparagraph (A) shall be made after providing such notice as the Sec- retary may require. (5) Revocation of accreditation If an accreditation body revokes the accredi- tation of a facility, the certificate of the facil- ity shall continue in effect until such time as may be determined by the Secretary. (6) Evaluation and report (A) Evaluation The Secretary shall evaluate annually the performance of each approved accreditation body by— (i) inspecting under subsection (g)(2) a sufficient number of the facilities accred- ited by the body to allow a reasonable esti- mate of the performance of the body; and (ii) such additional means as the Sec- retary determines to be appropriate. (B) Report The Secretary shall annually prepare and submit to the Committee on Labor and Human Resources of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that de- scribes the results of the evaluation con- ducted in accordance with subparagraph (A). (f) Quality standards (1) In general The standards referred to in subsection (d)(1)(B)(i) are standards established by the Secretary which include— (A) standards that require establishment and maintenance of a quality assurance and quality control program at each facility that is adequate and appropriate to ensure the reliability, clarity, and accuracy of in- terpretation of mammograms and standards for appropriate radiation dose; (B) standards that require use of radio- logical equipment specifically designed for mammography, including radiologic stand- ards and standards for other equipment and materials used in conjunction with such equipment; (C) a requirement that personnel who per- form mammography— (i)(I) be licensed by a State to perform radiological procedures; or (II) be certified as qualified to perform radiological procedures by an organization described in paragraph (2)(A); and (ii) during the 2-year period beginning October 1, 1994, meet training standards Page 492 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 263b for personnel who perform mammography or meet experience requirements which shall at a minimum include 1 year of expe- rience in the performance of mammog- raphy; and (iii) upon the expiration of such 2-year period meet minimum training standards for personnel who perform mammograms; (D) a requirement that mammograms be interpreted by a physician who is certified as qualified to interpret radiological proce- dures, including mammography— (i)(I) by a board described in paragraph (2)(B); or (II) by a program that complies with the standards described in paragraph (2)(C); and (ii) who meets training and continuing medical education requirements as estab- lished by the Secretary; (E) a requirement that individuals who survey mammography facilities be medical physicists— (i) licensed or approved by a State to perform such surveys, reviews, or inspec- tions for mammography facilities; (ii) certified in diagnostic radiological physics or certified as qualified to perform such surveys by a board as described in paragraph (2)(D); or (iii) in the first 5 years after October 27, 1992, who meet other criteria established by the Secretary which are comparable to the criteria described in clause (i) or (ii); (F) a requirement that a medical physicist who is qualified in mammography as de- scribed in subparagraph (E) survey mam- mography equipment and oversee quality as- surance practices at each facility; (G) a requirement that— (i) a facility that performs any mammo- gram— (I) except as provided in subclause (II), maintain the mammogram in the perma- nent medical records of the patient for a period of not less than 5 years, or not less than 10 years if no subsequent mam- mograms of such patient are performed at the facility, or longer if mandated by State law; and (II) upon the request of or on behalf of the patient, transfer the mammogram to a medical institution, to a physician of the patient, or to the patient directly; and (ii)(I) a facility must assure the prepara- tion of a written report of the results of any mammography examination signed by the interpreting physician; (II) such written report shall be provided to the patient’s physicians (if any); (III) if such a physician is not available or if there is no such physician, the writ- ten report shall be sent directly to the pa- tient; and (IV) whether or not such a physician is available or there is no such physician, a summary of the written report shall be sent directly to the patient in terms easily understood by a lay person; and (H) standards relating to special tech- niques for mammography of patients with breast implants. Subparagraph (G) shall not be construed to limit a patient’s access to the patient’s med- ical records. (2) Certification of personnel The Secretary shall by regulation— (A) specify organizations eligible to certify individuals to perform radiological proce- dures as required by paragraph (1)(C); (B) specify boards eligible to certify physi- cians to interpret radiological procedures, including mammography, as required by paragraph (1)(D); (C) establish standards for a program to certify physicians described in paragraph (1)(D); and (D) specify boards eligible to certify med- ical physicists who are qualified to survey mammography equipment and to oversee quality assurance practices at mammog- raphy facilities. (g) Inspections (1) Annual inspections (A) In general The Secretary may enter and inspect fa- cilities to determine compliance with the certification requirements under subsection (b) and the standards established under sub- section (f). The Secretary shall, if feasible, delegate to a State or local agency the au- thority to make such inspections. (B) Identification The Secretary, or State or local agency acting on behalf of the Secretary, may con- duct inspections only on presenting identi- fication to the owner, operator, or agent in charge of the facility to be inspected. (C) Scope of inspection In conducting inspections, the Secretary or State or local agency acting on behalf of the Secretary— (i) shall have access to all equipment, materials, records, and information that the Secretary or State or local agency considers necessary to determine whether the facility is being operated in accord- ance with this section; and (ii) may copy, or require the facility to submit to the Secretary or the State or local agency, any of the materials, records, or information. (D) Qualifications of inspectors Qualified individuals, as determined by the Secretary, shall conduct all inspections. The Secretary may request that a State or local agency acting on behalf of the Secretary designate a qualified officer or employee to conduct the inspections, or designate a qualified Federal officer or employee to con- duct inspections. The Secretary shall estab- lish minimum qualifications and appropriate training for inspectors and criteria for cer- tification of inspectors in order to inspect facilities for compliance with subsection (f). (E) Frequency The Secretary or State or local agency acting on behalf of the Secretary shall con- Page 493 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 263b duct inspections under this paragraph of each facility not less often than annually, subject to paragraph (6). (F) Records and annual reports The Secretary or a State or local agency acting on behalf of the Secretary which is responsible for inspecting mammography fa- cilities shall maintain records of annual in- spections required under this paragraph for a period as prescribed by the Secretary. Such a State or local agency shall annually pre- pare and submit to the Secretary a report concerning the inspections carried out under this paragraph. Such reports shall include a description of the facilities inspected and the results of such inspections. (2) Inspection of accredited facilities The Secretary shall inspect annually a suffi- cient number of the facilities accredited by an accreditation body to provide the Secretary with a reasonable estimate of the performance of such body. (3) Inspection of facilities inspected by State or local agencies The Secretary shall inspect annually facili- ties inspected by State or local agencies act- ing on behalf of the Secretary to assure a rea- sonable performance by such State or local agencies. (4) Timing The Secretary, or State or local agency, may conduct inspections under paragraphs (1), (2), and (3), during regular business hours or at a mutually agreeable time and after providing such notice as the Secretary may prescribe, except that the Secretary may waive such re- quirements if the continued performance of mammography at such facility threatens the public health. (5) Limited reinspection Nothing in this section limits the authority of the Secretary to conduct limited reinspec- tions of facilities found not to be in compli- ance with this section. (6) Demonstration program (A) In general The Secretary may establish a demonstra- tion program under which inspections under paragraph (1) of selected facilities are con- ducted less frequently by the Secretary (or as applicable, by State or local agencies act- ing on behalf of the Secretary) than the in- terval specified in subparagraph (E) of such paragraph. (B) Requirements Any demonstration program under sub- paragraph (A) shall be carried out in accord- ance with the following: (i) The program may not be implemented before April 1, 2001. Preparations for the program may be carried out prior to such date. (ii) In carrying out the program, the Sec- retary may not select a facility for inclu- sion in the program unless the facility is substantially free of incidents of non- compliance with the standards under sub- section (f). The Secretary may at any time provide that a facility will no longer be in- cluded in the program. (iii) The number of facilities selected for inclusion in the program shall be suffi- cient to provide a statistically significant sample, subject to compliance with clause (ii). (iv) Facilities that are selected for inclu- sion in the program shall be inspected at such intervals as the Secretary determines will reasonably ensure that the facilities are maintaining compliance with such standards. (h) Sanctions (1) In general In order to promote voluntary compliance with this section, the Secretary may, in lieu of taking the actions authorized by subsection (i), impose one or more of the following sanc- tions: (A) Directed plans of correction which af- ford a facility an opportunity to correct vio- lations in a timely manner. (B) Payment for the cost of onsite moni- toring. (2) Patient information If the Secretary determines that the quality of mammography performed by a facility (whether or not certified pursuant to sub- section (c)) was so inconsistent with the qual- ity standards established pursuant to sub- section (f) as to present a significant risk to individual or public health, the Secretary may require such facility to notify patients who re- ceived mammograms at such facility, and their referring physicians, of the deficiencies presenting such risk, the potential harm re- sulting, appropriate remedial measures, and such other relevant information as the Sec- retary may require. (3) Civil money penalties The Secretary may assess civil money pen- alties in an amount not to exceed $10,000 for— (A) failure to obtain a certificate as re- quired by subsection (b), (B) each failure by a facility to substan- tially comply with, or each day on which a facility fails to substantially comply with, the standards established under subsection (f) or the requirements described in sub- clauses (I) through (III) of subsection (d)(1)(B)(ii), (C) each failure to notify a patient of risk as required by the Secretary pursuant to paragraph (2), and (D) each violation, or for each aiding and abetting in a violation of, any provision of, or regulation promulgated under, this sec- tion by an owner, operator, or any employee of a facility required to have a certificate. (4) Procedures The Secretary shall develop and implement procedures with respect to when and how each of the sanctions is to be imposed under para- graphs (1) through (3). Such procedures shall provide for notice to the owner or operator of Page 494 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 263b the facility and a reasonable opportunity for the owner or operator to respond to the pro- posed sanctions and appropriate procedures for appealing determinations relating to the im- position of sanctions. (i) Suspension and revocation (1) In general The certificate of a facility issued under sub- section (c) may be suspended or revoked if the Secretary finds, after providing, except as pro- vided in paragraph (2), reasonable notice and an opportunity for a hearing to the owner or operator of the facility, that the owner, oper- ator, or any employee of the facility— (A) has been guilty of misrepresentation in obtaining the certificate; (B) has failed to comply with the require- ments of subsection (d)(1)(B)(ii)(III) or the standards established by the Secretary under subsection (f); (C) has failed to comply with reasonable requests of the Secretary (or of an accredita- tion body approved pursuant to subsection (e)) for any record, information, report, or material that the Secretary (or such accred- itation body or State carrying out certifi- cation program requirements pursuant to subsection (q)) concludes is necessary to de- termine the continued eligibility of the fa- cility for a certificate or continued compli- ance with the standards established under subsection (f); (D) has refused a reasonable request of the Secretary, any Federal officer or employee duly designated by the Secretary, or any State or local officer or employee duly des- ignated by the State or local agency, for per- mission to inspect the facility or the oper- ations and pertinent records of the facility in accordance with subsection (g); (E) has violated or aided and abetted in the violation of any provision of, or regula- tion promulgated under, this section; or (F) has failed to comply with a sanction imposed under subsection (h). (2) Action before a hearing (A) In general The Secretary may suspend the certificate of the facility before holding a hearing re- quired by paragraph (1) if the Secretary has reason to believe that the circumstance of the case will support one or more of the find- ings described in paragraph (1) and that— (i) the failure or violation was inten- tional; or (ii) the failure or violation presents a se- rious risk to human health. (B) Hearing If the Secretary suspends a certificate under subparagraph (A), the Secretary shall provide an opportunity for a hearing to the owner or operator of the facility not later than 60 days from the effective date of the suspension. The suspension shall remain in effect until the decision of the Secretary made after the hearing. (3) Ineligibility to own or operate facilities after revocation If the Secretary revokes the certificate of a facility on the basis of an act described in paragraph (1), no person who owned or oper- ated the facility at the time of the act may, within 2 years of the revocation of the certifi- cate, own or operate a facility that requires a certificate under this section. (j) Injunctions If the Secretary determines that— (1) continuation of any activity related to the provision of mammography by a facility would constitute a serious risk to human health, the Secretary may bring suit in the district court of the United States for the dis- trict in which the facility is situated to enjoin continuation of the activity; and (2) a facility is operating without a certifi- cate as required by subsection (b), the Sec- retary may bring suit in the district court of the United States for the district in which the facility is situated to enjoin the operation of the facility. Upon a proper showing, the district court shall grant a temporary injunction or restraining order against continuation of the activity or against operation of a facility, as the case may be, without requiring the Secretary to post a bond, pending issuance of a final order under this subsection. (k) Judicial review (1) Petition If the Secretary imposes a sanction on a fa- cility under subsection (h) or suspends or re- vokes the certificate of a facility under sub- section (i), the owner or operator of the facil- ity may, not later than 60 days after the date the action of the Secretary becomes final, file a petition with the United States court of ap- peals for the circuit in which the facility is situated for judicial review of the action. As soon as practicable after receipt of the peti- tion, the clerk of the court shall transmit a copy of the petition to the Secretary or other officer designated by the Secretary. As soon as practicable after receipt of the copy, the Sec- retary shall file in the court the record on which the action of the Secretary is based, as provided in section 2112 of title 28. (2) Additional evidence If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that the addi- tional evidence is material and that there were reasonable grounds for the failure to ad- duce such evidence in the proceeding before the Secretary, the court may order the addi- tional evidence (and evidence in rebuttal of the additional evidence) to be taken before the Secretary, and to be adduced upon the hearing in such manner and upon such terms and con- ditions as the court may determine to be prop- er. The Secretary may modify the findings of the Secretary as to the facts, or make new findings, by reason of the additional evidence so taken, and the Secretary shall file the modified or new findings, and the rec- ommendations of the Secretary, if any, for the modification or setting aside of the original action of the Secretary with the return of the additional evidence. Page 495 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 263b (3) Judgment of court Upon the filing of the petition referred to in paragraph (1), the court shall have jurisdiction to affirm the action, or to set the action aside in whole or in part, temporarily or perma- nently. The findings of the Secretary as to the facts, if supported by substantial evidence, shall be conclusive. (4) Finality of judgment The judgment of the court affirming or set- ting aside, in whole or in part, any action of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification, as provided in section 1254 of title 28. (l) Information (1) In general Not later than October 1, 1996, and annually thereafter, the Secretary shall compile and make available to physicians and the general public information that the Secretary deter- mines is useful in evaluating the performance of facilities, including a list of facilities— (A) that have been convicted under Fed- eral or State laws relating to fraud and abuse, false billings, or kickbacks; (B) that have been subject to sanctions under subsection (h), together with a state- ment of the reasons for the sanctions; (C) that have had certificates revoked or suspended under subsection (i), together with a statement of the reasons for the rev- ocation or suspension; (D) against which the Secretary has taken action under subsection (j), together with a statement of the reasons for the action; (E) whose accreditation has been revoked, together with a statement of the reasons of the revocation; (F) against which a State has taken ad- verse action; and (G) that meets such other measures of per- formance as the Secretary may develop. (2) Date The information to be compiled under para- graph (1) shall be information for the calendar year preceding the date the information is to be made available to the public. (3) Explanatory information The information to be compiled under para- graph (1) shall be accompanied by such explan- atory information as may be appropriate to assist in the interpretation of the information compiled under such paragraph. (m) State laws Nothing in this section shall be construed to limit the authority of any State to enact and enforce laws relating to the matters covered by this section that are at least as stringent as this section or the regulations issued under this sec- tion. (n) National Advisory Committee (1) Establishment In carrying out this section, the Secretary shall establish an advisory committee to be known as the National Mammography Quality Assurance Advisory Committee (hereafter in this subsection referred to as the ‘‘Advisory Committee’’). (2) Composition The Advisory Committee shall be composed of not fewer than 13, nor more than 19 individ- uals, who are not officers or employees of the Federal Government. The Secretary shall make appointments to the Advisory Com- mittee from among— (A) physicians, (B) practitioners, and (C) other health professionals, whose clinical practice, research specializa- tion, or professional expertise include a sig- nificant focus on mammography. The Sec- retary shall appoint at least 4 individuals from among national breast cancer or consumer health organizations with expertise in mam- mography, at least 2 industry representatives with expertise in mammography equipment, and at least 2 practicing physicians who pro- vide mammography services. (3) Functions and duties The Advisory Committee shall— (A) advise the Secretary on appropriate quality standards and regulations for mam- mography facilities; (B) advise the Secretary on appropriate standards and regulations for accreditation bodies; (C) advise the Secretary in the develop- ment of regulations with respect to sanc- tions; (D) assist in developing procedures for monitoring compliance with standards under subsection (f); (E) make recommendations and assist in the establishment of a mechanism to inves- tigate consumer complaints; (F) report on new developments con- cerning breast imaging that should be con- sidered in the oversight of mammography fa- cilities; (G) determine whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determine the effects of personnel or other requirements of subsection (f) on access to the services of such facilities in such areas; (H) determine whether there will exist a sufficient number of medical physicists after October 1, 1999, to assure compliance with the requirements of subsection (f)(1)(E); (I) determine the costs and benefits of compliance with the requirements of this section (including the requirements of regu- lations promulgated under this section); and (J) perform other activities that the Sec- retary may require. The Advisory Committee shall report the find- ings made under subparagraphs (G) and (I) to the Secretary and the Congress no later than October 1, 1993. (4) Meetings The Advisory Committee shall meet not less than quarterly for the first 3 years of the pro- gram and thereafter, at least annually. Page 496 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 263b (5) Chairperson The Secretary shall appoint a chairperson of the Advisory Committee. (o) Consultations In carrying out this section, the Secretary shall consult with appropriate Federal agencies within the Department of Health and Human Services for the purposes of developing stand- ards, regulations, evaluations, and procedures for compliance and oversight. (p) Breast cancer screening surveillance re- search grants (1) Research (A) Grants The Secretary shall award grants to such entities as the Secretary may determine to be appropriate to establish surveillance sys- tems in selected geographic areas to provide data to evaluate the functioning and effec- tiveness of breast cancer screening programs in the United States, including assessments of participation rates in screening mammog- raphy, diagnostic procedures, incidence of breast cancer, mode of detection (mammog- raphy screening or other methods), outcome and follow up information, and such related epidemiologic analyses that may improve early cancer detection and contribute to re- duction in breast cancer mortality. Grants may be awarded for further research on breast cancer surveillance systems upon the Secretary’s review of the evaluation of the program. (B) Use of funds Grants awarded under subparagraph (A) may be used— (i) to study— (I) methods to link mammography and clinical breast examination records with population-based cancer registry data; (II) methods to provide diagnostic out- come data, or facilitate the communica- tion of diagnostic outcome data, to radi- ology facilities for purposes of evalu- ating patterns of mammography inter- pretation; and (III) mechanisms for limiting access and maintaining confidentiality of all stored data; and (ii) to conduct pilot testing of the meth- ods and mechanisms described in sub- clauses (I), (II), and (III) of clause (i) on a limited basis. (C) Grant application To be eligible to receive funds under this paragraph, an entity shall submit an appli- cation to the Secretary at such time, in such manner, and containing such information as the Secretary may require. (D) Report A recipient of a grant under this paragraph shall submit a report to the Secretary con- taining the results of the study and testing conducted under clauses (i) and (ii) of sub- paragraph (B), along with recommendations for methods of establishing a breast cancer screening surveillance system. (2) Establishment The Secretary shall establish a breast can- cer screening surveillance system based on the recommendations contained in the report de- scribed in paragraph (1)(D). (3) Standards and procedures The Secretary shall establish standards and procedures for the operation of the breast can- cer screening surveillance system, including procedures to maintain confidentiality of pa- tient records. (4) Information The Secretary shall recruit facilities to pro- vide to the breast cancer screening surveil- lance system relevant data that could help in the research of the causes, characteristics, and prevalence of, and potential treatments for, breast cancer and benign breast conditions, if the information may be disclosed under sec- tion 552 of title 5. (q) State program (1) In general The Secretary may, upon application, au- thorize a State— (A) to carry out, subject to paragraph (2), the certification program requirements under subsections (b), (c), (d), (g)(1), (h), (i), and (j) (including the requirements under regulations promulgated pursuant to such subsections), and (B) to implement the standards established by the Secretary under subsection (f), with respect to mammography facilities oper- ating within the State. (2) Approval The Secretary may approve an application under paragraph (1) if the Secretary deter- mines that— (A) the State has enacted laws and issued regulations relating to mammography facili- ties which are the requirements of this sec- tion (including the requirements under regu- lations promulgated pursuant to such sub- sections), and (B) the State has provided satisfactory as- surances that the State— (i) has the legal authority and qualified personnel necessary to enforce the require- ments of and the regulations promulgated pursuant to this section (including the re- quirements under regulations promulgated pursuant to such subsections), (ii) will devote adequate funds to the ad- ministration and enforcement of such re- quirements, and (iii) will provide the Secretary with such information and reports as the Secretary may require. (3) Authority of Secretary In a State with an approved application— (A) the Secretary shall carry out the Sec- retary’s functions under subsections (e) and (f); (B) the Secretary may take action under subsections (h), (i), and (j); and (C) the Secretary shall conduct oversight functions under subsections (g)(2) and (g)(3). Page 497 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 263b (4) Withdrawal of approval (A) In general The Secretary may, after providing notice and opportunity for corrective action, with- draw the approval of a State’s authority under paragraph (1) if the Secretary deter- mines that the State does not meet the re- quirements of such paragraph. The Sec- retary shall promulgate regulations for the implementation of this subparagraph. (B) Effect of withdrawal If the Secretary withdraws the approval of a State under subparagraph (A), the certifi- cate of any facility certified by the State shall continue in effect until the expiration of a reasonable period, as determined by the Secretary, for such facility to obtain certifi- cation by the Secretary. (r) Funding (1) Fees (A) In general The Secretary shall, in accordance with this paragraph assess and collect fees from persons described in subsection (d)(1)(A) (other than persons who are governmental entities, as determined by the Secretary) to cover the costs of inspections conducted under subsection (g)(1) by the Secretary or a State acting under a delegation under sub- paragraph (A) of such subsection. Fees may be assessed and collected under this para- graph only in such manner as would result in an aggregate amount of fees collected during any fiscal year which equals the ag- gregate amount of costs for such fiscal year for inspections of facilities of such persons under subsection (g)(1). A person’s liability for fees shall be reasonably based on the pro- portion of the inspection costs which relate to such person. (B) Deposit and appropriations (i) Deposit and availability Fees collected under subparagraph (A) shall be deposited as an offsetting collec- tion to the appropriations for the Depart- ment of Health and Human Services as provided in appropriation Acts and shall remain available without fiscal year limi- tation. (ii) Appropriations Fees collected under subparagraph (A) shall be collected and available only to the extent provided in advance in appropria- tion Acts. (2) Authorization of appropriations There are authorized to be appropriated to carry out this section— (A) to award research grants under sub- section (p), such sums as may be necessary for each of the fiscal years 1993 through 2007; and (B) for the Secretary to carry out other ac- tivities which are not supported by fees au- thorized and collected under paragraph (1), such sums as may be necessary for fiscal years 1993 through 2007. (July 1, 1944, ch. 373, title III, § 354, as added Pub. L. 102–539, § 2, Oct. 27, 1992, 106 Stat. 3547; amend- ed Pub. L. 105–248, §§ 2–13, Oct. 9, 1998, 112 Stat. 1864–1867; Pub. L. 108–365, §§ 2–4, Oct. 25, 2004, 118 Stat. 1738–1740.) Editorial Notes PRIOR PROVISIONS A prior section 263b, act July 1, 1944, ch. 373, title III, § 354, as added Oct. 18, 1968, Pub. L. 90–602, § 2(3), 82 Stat. 1173; amended Nov. 28, 1990, Pub. L. 101–629, § 19(a)(1)(B), 104 Stat. 4529; Aug. 13, 1993, Pub. L. 103–80, § 4(a)(2), 107 Stat. 779, set forth Congressional declaration of pur- pose, prior to repeal by Pub. L. 101–629, § 19(a)(3), Nov. 28, 1990, 104 Stat. 4530. Sections 263c to 263n, act July 1, 1944, ch. 373, title III, §§ 355–360F, as added Oct. 18, 1968, Pub. L. 90–602, § 2(3), 82 Stat. 1174, and amended, which related to electronic product radiation control, were renumbered sections 531 to 542, respectively, of the Federal Food, Drug, and Cosmetic Act by Pub. L. 101–629, § 19(a)(4), Nov. 28, 1990, 104 Stat. 4530, and are classified to sections 360hh to 360ss, respectively, of Title 21, Food and Drugs. AMENDMENTS 2004—Subsec. (b)(1). Pub. L. 108–365, § 2(1)(C), sub- stituted ‘‘temporary renewal certificate, provisional certificate, or a limited provisional certificate’’ for ‘‘provisional certificate’’ in concluding provisions. Subsec. (b)(1)(A). Pub. L. 108–365, § 2(1)(A), inserted ‘‘or a temporary renewal certificate’’ after ‘‘certifi- cate’’ in introductory provisions and substituted ‘‘para- graphs (1) or (2) of subsection (c)’’ for ‘‘subsection (c)(1)’’ in cl. (i). Subsec. (b)(1)(B). Pub. L. 108–365, § 2(1)(B), inserted ‘‘or a limited provisional certificate’’ after ‘‘certifi- cate’’ in introductory provisions and substituted ‘‘para- graphs (3) and (4) of subsection (c)’’ for ‘‘subsection (c)(2)’’ in cl. (i). Subsec. (c)(2) to (4). Pub. L. 108–365, § 2(2), added pars. (2) and (3) and redesignated former par. (2) as (4). Subsec. (n)(2). Pub. L. 108–365, § 3(1), reenacted subpar. (C) without change, added concluding provisions, and struck out former concluding provisions which read as follows: ‘‘whose clinical practice, research specializa- tion, or professional expertise include a significant focus on mammography. The Secretary shall appoint at least 4 individuals from among national breast cancer or consumer health organizations with expertise in mammography and at least 2 practicing physicians who provide mammography services.’’ Subsec. (n)(4). Pub. L. 108–365, § 3(2), substituted ‘‘an- nually’’ for ‘‘biannually’’. Subsec. (r)(2). Pub. L. 108–365, § 4, substituted ‘‘2007’’ for ‘‘2002’’ in subpars. (A) and (B). 1998—Subsec. (a)(4). Pub. L. 105–248, § 9(1), inserted ‘‘or local’’ after ‘‘State’’. Subsec. (a)(8). Pub. L. 105–248, § 4(b), added par. (8). Subsec. (d)(2)(B). Pub. L. 105–248, § 3, substituted ‘‘part 498 of title 42, Code of Federal Regulations’’ for ‘‘42 C.F.R. 498 and in effect on October 27, 1992’’. Subsec. (e)(1)(B)(i)(I), (II). Pub. L. 105–248, § 4(a)(1), substituted ‘‘review physicians’’ for ‘‘practicing physi- cians’’. Subsec. (e)(1)(B)(ii). Pub. L. 105–248, § 4(a)(2), sub- stituted ‘‘relationship’’ for ‘‘financial relationship’’. Subsec. (f)(1)(G)(i). Pub. L. 105–248, § 5, added cl. (i) and struck out former cl. (i) which read as follows: ‘‘a facility that performs any mammogram maintain the mammogram in the permanent medical records of the patient— ‘‘(I) for a period of not less than 5 years, or not less than 10 years if no additional mammograms of such patient are performed at the facility, or longer if mandated by State law; or ‘‘(II) until such time as the patient should request that the patient’s medical records be forwarded to a medical institution or a physician of the patient; Page 498 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 264 1 So in original. The comma probably should not appear. whichever is longer; and’’. Subsec. (f)(1)(G)(ii)(IV). Pub. L. 105–248, § 6, added subcl. (IV) and struck out former subcl. (IV) which read as follows: ‘‘if such report is sent to the patient, the re- port shall include a summary written in terms easily understood by a lay person; and’’. Subsec. (g)(1). Pub. L. 105–248, § 9(1), inserted ‘‘or local’’ after ‘‘State’’ wherever appearing. Subsec. (g)(1)(A). Pub. L. 105–248, § 7, in first sentence, struck out ‘‘certified’’ before ‘‘facilities’’ and inserted ‘‘the certification requirements under subsection (b) and’’ after ‘‘compliance with’’. Subsec. (g)(1)(E). Pub. L. 105–248, § 8(1), inserted ‘‘, subject to paragraph (6)’’ before period at end. Subsec. (g)(3). Pub. L. 105–248, § 9(1), (2), inserted ‘‘or local’’ after ‘‘State’’ in heading and in two places in text. Subsec. (g)(4). Pub. L. 105–248, § 9(1), inserted ‘‘or local’’ after ‘‘State’’. Subsec. (g)(6). Pub. L. 105–248, § 8(2), added par. (6). Subsec. (h)(2). Pub. L. 105–248, § 10(a), added par. (2) and redesignated former par. (2) as (3). Subsec. (h)(3). Pub. L. 105–248, § 10(a)(1), (b), redesig- nated par. (2) as (3), added subpar. (C), and redesignated former subpar. (C) as (D). Former par. (3) redesignated (4). Subsec. (h)(4). Pub. L. 105–248, § 10(a)(1), (c), redesig- nated par. (3) as (4) and substituted ‘‘paragraphs (1) through (3)’’ for ‘‘paragraphs (1) and (2)’’. Subsec. (i)(1)(C). Pub. L. 105–248, § 11, inserted ‘‘(or of an accreditation body approved pursuant to subsection (e))’’ after ‘‘of the Secretary’’ and inserted ‘‘(or such ac- creditation body or State carrying out certification program requirements pursuant to subsection (q))’’ after ‘‘that the Secretary’’. Subsec. (i)(1)(D). Pub. L. 105–248, § 9(3), inserted ‘‘or local’’ after ‘‘any State’’ and ‘‘or local agency’’ after ‘‘by the State’’. Subsec. (i)(2)(A). Pub. L. 105–248, § 12, substituted ‘‘has reason to believe that the circumstance of the case will support one or more of the findings described in para- graph (1) and that—’’ and cls. (i) and (ii) for ‘‘makes the finding described in paragraph (1) and determines that— ‘‘(i) the failure of a facility to comply with the standards established by the Secretary under sub- section (f) of this section presents a serious risk to human health; or ‘‘(ii) a facility has engaged in an action described in subparagraph (D) or (E) of paragraph (1).’’ Subsec. (q)(4)(B). Pub. L. 105–248, § 13, substituted ‘‘certified’’ for ‘‘accredited’’. Subsec. (r)(2)(A). Pub. L. 105–248, § 2, substituted ‘‘sub- section (p)’’ for ‘‘subsection (q)’’ and ‘‘2002’’ for ‘‘1997’’. Subsec. (r)(2)(B). Pub. L. 105–248, § 2, substituted ‘‘fis- cal years’’ for ‘‘fiscal year’’ and ‘‘2002’’ for ‘‘1997’’. Statutory Notes and Related Subsidiaries CHANGE OF NAME Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999. Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of Pub. L. 104–14, set out as a note preceding section 21 of Title 2, The Congress. Committee on Commerce of House of Representatives changed to Committee on En- ergy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and ex- changes and insurance generally transferred to Com- mittee on Financial Services of House of Representa- tives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001. TERMINATION OF ADVISORY COMMITTEES Advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by Congress, its duration is otherwise provided for by law. See section 1013 of Title 5, Government Organization and Employees. Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as a note under section 217a of this title, provided that an advisory committee established pursuant to the Public Health Service Act shall terminate at such time as may be specifically prescribed by an Act of Congress enacted after Jan. 4, 1975. REGULATIONS Pub. L. 103–183, title VII, § 707, Dec. 14, 1993, 107 Stat. 2241, provided that: ‘‘The Secretary of Health and Human Services is authorized to issue interim final regulations— ‘‘(1) under which the Secretary may approve accred- itation bodies under section 354(e) of the Public Health Service Act (42 U.S.C. 263b(e)); and ‘‘(2) establishing quality standards under section 354(f) of the Public Health Service Act (42 U.S.C. 263b(f)).’’ STUDY Section 3 of Pub. L. 102–539 directed Comptroller Gen- eral of United States to conduct a study of the certifi- cation program authorized by this section to determine if the program has resulted in improvement of quality and accessibility of mammography services, and if the program has reduced the frequency of poor quality mammography and improved early detection of breast cancer, with Comptroller General, not later than 3 years from Oct. 27, 1992, submit to Congress an interim report of results of study and, not later than 5 years from such date to submit a final report. PART G—QUARANTINE AND INSPECTION § 264. Regulations to control communicable dis- eases (a) Promulgation and enforcement by Surgeon General The Surgeon General, with the approval of the Secretary, is authorized to make and enforce such regulations as in his judgment are nec- essary to prevent the introduction, trans- mission, or spread of communicable diseases from foreign countries into the States or posses- sions, or from one State or possession into any other State or possession. For purposes of car- rying out and enforcing such regulations, the Surgeon General may provide for such inspec- tion, fumigation, disinfection, sanitation, pest extermination, destruction of animals or arti- cles found to be so infected or contaminated as to be sources of dangerous infection to human beings, and other measures, as in his judgment may be necessary. (b) Apprehension, detention, or conditional re- lease of individuals Regulations prescribed under this section shall not provide for the apprehension, deten- tion, or conditional release of individuals except for the purpose of preventing the introduction, transmission, or spread of such communicable diseases as may be specified from time to time in Executive orders of the President upon the recommendation of the Secretary, in consulta- tion with the Surgeon General,1.