Breast and Cervical Cancer Early Detection Federal Advisory Committee, 71193 [2012-28858]

Download as PDF Federal Register / Vol. 77, No. 230 / Thursday, November 29, 2012 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention (CDC) Breast and Cervical Cancer Early Detection Federal Advisory Committee Correction: This notice was published in the Federal Register on November 5, 2012, Volume 77, Number 214, Page 66469. A teleconference line has been added for public participation. To participate, please dial toll-free 1 (866) 756–7359 and enter passcode 8958302 for access. Participation by teleconference is limited by the number of ports available. Contact Person for More Information: Alicia Ortner, Committee Specialist, CDC, 4770 Buford Hwy, M/S K–57, Atlanta, Georgia 30341. Telephone (770) 488–4880. Email: aortner@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: November 21, 2012. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2012–28858 Filed 11–28–12; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0099] Agency Information Collection Activities; Proposed Collection; Comment Request; Revision of the Requirements for Constituent Materials AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 pmangrum on DSK3VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 15:12 Nov 28, 2012 Jkt 229001 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 regarding the requirement for the use of constituent materials in licensed biological products. DATES: Submit either electronic or written comments on the collection of information by January 28, 2013. ADDRESSES: Submit electronic comments on the collection of information to http:// 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: Ila S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 7726, Ila.Mizrachi@fda.hhs.gov. 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 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 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 71193 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. Revision of the Requirements for Constituent Materials in Biological Products—21 CFR 610.15(d) (OMB Control Number 0910–0666)—Extension In the Federal Register of April 13, 2011 (76 FR 20513), FDA issued a final rule amending the regulation for the use of constituent materials in licensed biological products. Under 21 CFR 610.15(d), the Director of the Center for Biologics Evaluation and Research (CBER) or the Director of the Center for Drugs Evaluation and Research (CDER) may approve, as appropriate, a manufacturer’s request for exceptions or alternatives to the regulation for constituent materials. Thus, the provision provides manufacturers of biological products with flexibility, as appropriate, to employ advances in science and technology as they become available, without diminishing public health protections. Manufacturers seeking approval of an exception or alternative must submit a request in writing. The request must be clearly identified with a brief statement describing the basis for the request and the supporting data. The request may be submitted as part of the original biologics application, as an amendment to the original, pending application or as a prior approval supplement to an approved application. The information to be collected assists FDA in identifying and reviewing requests for an exception or alternative to the requirements for constituent materials. Respondents to this information collection provision are manufacturers of biological products. Since implementation of the final rule, FDA has received no submissions of requests for an exception or alternative for constituent materials. Therefore, FDA is estimating one respondent and annual response annually to account for a possible submission to CBER or CDER of a request for an exception or alternative for constituent materials. The average burden per response is based on FDA experience with similar information collection requirements. FDA estimates the burden of this collection of information as follows: E:\FR\FM\29NON1.SGM 29NON1

Agencies

[Federal Register Volume 77, Number 230 (Thursday, November 29, 2012)]
[Notices]
[Page 71193]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28858]



[[Page 71193]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention (CDC)


Breast and Cervical Cancer Early Detection Federal Advisory 
Committee

    Correction: This notice was published in the Federal Register on 
November 5, 2012, Volume 77, Number 214, Page 66469. A teleconference 
line has been added for public participation. To participate, please 
dial toll-free 1 (866) 756-7359 and enter passcode 8958302 for access. 
Participation by teleconference is limited by the number of ports 
available.
    Contact Person for More Information: Alicia Ortner, Committee 
Specialist, CDC, 4770 Buford Hwy, M/S K-57, Atlanta, Georgia 30341. 
Telephone (770) 488-4880. Email: aortner@cdc.gov. The Director, 
Management Analysis and Services Office, has been delegated the 
authority to sign Federal Register notices pertaining to announcements 
of meetings and other committee management activities, for both the 
Centers for Disease Control and Prevention and the Agency for Toxic 
Substances and Disease Registry.

    Dated: November 21, 2012.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention.
[FR Doc. 2012-28858 Filed 11-28-12; 8:45 am]
BILLING CODE 4163-18-P