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