[Federal Register Volume 74, Number 82 (Thursday, April 30, 2009)]
[Notices]
[Pages 19973-19974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-9699]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Statement of Delegation of Authority

    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.

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    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.

    Dated: April 21, 2009.
Charles E. Johnson,
Acting Secretary.
[FR Doc. E9-9699 Filed 4-29-09; 8:45 am]
BILLING CODE 4140-01-M