Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Pharmaceutical Development Study, 54044 [E7-18641]

Download as PDF 54044 Federal Register / Vol. 72, No. 183 / Friday, September 21, 2007 / Notices Dated: September 13, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7–18494 Filed 9–20–07; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Pharmaceutical Development Study Food and Drug Administration, HHS. Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Pharmaceutical Development Study’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4816. In the Federal Register of February 13, 2006 (71 FR 7556), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0604. The approval expires on August 31, 2010. A copy of the supporting statement for this information collection is available on the Internet at https://www.fda.gov/ ohrms/dockets. mstockstill on PROD1PC66 with NOTICES SUPPLEMENTARY INFORMATION: Dated: September 14, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–18641 Filed 9–20–07; 8:45 am] VerDate Aug<31>2005 18:17 Sep 20, 2007 Jkt 211001 Food and Drug Administration, HHS. [Docket No. 2005N–0353] BILLING CODE 4160–01–S [Docket No. 2007N–0337] AGENCY: Food and Drug Administration ACTION: Food and Drug Administration Agency Information Collection Activities: Proposed Collection; Comment Request; Radioactive Drug Research Committees BILLING CODE 4120–01–P AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in regulations governing the use of radioactive drugs for basic informational research. DATES: Submit written or electronic comments on the collection of information by November 20, 2007. ADDRESSES: Submit electronic comments on the collection of information to: https://www.fda.gov/ dockets/ecomments or https:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Karen L. Nelson Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, rm. 1061, Rockville, MD 20857, 301–827–4816. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Radioactive Drug Research Committees— 21 CFR 361.1 (OMB Control Number 0910–0053) Under sections 201, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 355, and 371), FDA has the authority to issue regulations governing the use of radioactive drugs for basic scientific research. Section 361.1 (21 CFR 361.1) sets forth specific regulations regarding the establishment and composition of Radioactive Drug Research Committees and their role in approving and monitoring basic research studies utilizing radiopharmaceuticals. No basic research study involving any administration of a radioactive drug to research subjects is permitted without the authorization of an FDA approved Radioactive Drug Research Committee (§ 361.1(d)(7)). The type of research that may be undertaken with a radiopharmaceutical drug must be intended to obtain basic information and not to carry out a clinical trial for safety or efficacy. The types of basic research permitted are specified in the regulation, and include studies of metabolism, human physiology, pathophysiology, or biochemistry. Section 361.1(c)(2) requires that each Radioactive Drug Research Committee shall select a chairman, who shall sign all applications, minutes, and reports of the committee. Each committee shall meet at least once each quarter in which research activity has been authorized or E:\FR\FM\21SEN1.SGM 21SEN1

Agencies

[Federal Register Volume 72, Number 183 (Friday, September 21, 2007)]
[Notices]
[Page 54044]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18641]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0353]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Pharmaceutical Development Study

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Pharmaceutical Development Study'' 
has been approved by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4816.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 13, 2006 
(71 FR 7556), the agency announced that the proposed information 
collection had been submitted to OMB for review and clearance under 44 
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number. OMB has now approved the 
information collection and has assigned OMB control number 0910-0604. 
The approval expires on August 31, 2010. A copy of the supporting 
statement for this information collection is available on the Internet 
at https://www.fda.gov/ohrms/dockets.

    Dated: September 14, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-18641 Filed 9-20-07; 8:45 am]
BILLING CODE 4160-01-S
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