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Notice is hereby given that I have delegated to the Director, National Institutes of Health (NIH), the authorities added to the Public Health Service Act by Section 801 of Public Law 110-85, the Food and Drug Administration Amendments Act of 2007, 42 U.S.C. 282(j), as amended, pertaining to the expansion of the Clinical Trial Registry and Results Data Bank described therein. Specifically, the Director is delegated the following authorities:
1. 402(j)(2)(A)(ii)(IV), 42 U.S.C. 282(j)(2)(A)(ii)(IV): The Secretary may make publicly available certain administrative data collected for the registry, as necessary.
2. 402(j)(3)(A)(i), 42 U.S.C. 282(j)(3)(A)(i): To ensure that the Data Bank includes links to results information for those trials that form the primary basis for an efficacy claim or are performed after clearance or approval of the drug or device, under 42 U.S.C. 282(j)(3)(A)(i).
3. 402(j)(3)(A)(ii)(I), 42 U.S.C. 282(j)(3)(A)(ii)(I): To ensure that the Data Bank includes links to specified FDA information.Start Printed Page 19974
4. 402(j)(3)(A)(ii)(II), 42 U.S.C. 282(j)(3)(A)(ii)(II): To ensure that the Data Bank includes links to specified NIH information.
5. 402(j)(3)(A)(ii)(iii), 42 U.S.C. 282(j)(3)(A)(ii)(iii): To include links to the FDA and NIH information described above for Data Bank entries for clinical trials submitted to the Data Bank prior to the enactment of FDAAA.
6. 402(j)(3)(C), 42 U.S.C. 282(j)(3)(C): To include in the Data Bank the specified “basic results” information for drugs that are approved under section 505 of the Federal Food, Drug and Cosmetic Act or licensed under section 351 of the Public Health Service Act, and for devices that are cleared under section 510(k) of the Federal Food, Drug and Cosmetic Act, or approved under section 515 or 520(m) of the Federal Food, Drug, and Cosmetic Act.
7. 402(j)(3)(D)(vi), 42 U.S.C. 282(j)(3)(D)(vi): To consider the status of World Health Organization consensus data elements for reporting clinical trial results when issuing regulations.
8. 402(j)(3)(D)(vii), 42 U.S.C. 282(j)(3)(D)(vii): To hold a public meeting to provide an opportunity for input from interested parties with regard to the regulations to be issued pursuant to 42 U.S.C. 282(j)(3)(D)(i).
9. 402(j)(3)(I)(iii), 42 U.S.C. 282(j)(3)(I)(iii): To include in the Data Bank tables of information of anticipated and unanticipated serious adverse events and anticipated and unanticipated frequent adverse events, upon the application of 42 U.S.C. 282(j)(3)(I)(ii).
10. 402(j)(3)(I)(iv), 42 U.S.C. 282(j)(I)(iv): To consult with experts in risk communication and post, with the tables described in 42 U.S.C. 282(j)(3)(I)(iii), information to enhance patient understanding and to ensure such tables do not mislead patients or the lay public.
11. 402(j)(4)(B)(i), 42 U.S.C. 282(j)(B)(i): To determine for a specified clinical trial, that posting in the Data Bank of clinical trial information for such clinical trial is necessary to protect the public health, and further, to require by notification that such information be submitted to, and accepted on behalf of the Secretary by, the Director of the National Institutes of Health, in accord with 42 U.S.C. 282(j)(4)(B)(i)(I).
12. 402(j)(5)(A)(iv), 42 U.S.C. 282(j)(5)(A)(iv): To consult with other agencies that conduct human subjects research in accordance with any section of part 46 of title 45, Code of Federal Regulations (or any successor regulation), to determine if such research is an applicable clinical trial and develop, with such agencies, procedures to ensure the submission of clinical trial information.
13. 402(j)(5)(C)(i), 42 U.S.C. 282(j)(5)(C)(i): To use the publicly available information and any other information available to the Secretary about applicable clinical trials to verify the accuracy of submitted results information for the Pilot Quality Control Study.
This delegation will be exercised in accordance with the Department's applicable policies, procedures, guidelines and regulations.
I ratify and affirm any actions taken by you or your subordinates that involved the exercise of the authorities delegated herein prior to the effective date of this delegation. This delegation is effective upon date of signature.Start Signature
Dated: April 21, 2009.
Charles E. Johnson,
[FR Doc. E9-9699 Filed 4-29-09; 8:45 am]
BILLING CODE 4140-01-M