Agency Information Collection Activities; Proposed Collection; Comment Request; Revision of the Requirements for Constituent Materials, 71193-71194 [2012-28907]
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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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SUMMARY:
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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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71194
Federal Register / Vol. 77, No. 230 / Thursday, November 29, 2012 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
No. of
respondents
No. of
responses
per
respondent
Total annual
responses
Average
burden per
response
Total hours
610.15 ..................................................................................
1
1
1
1
1
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–28907 Filed 11–28–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–1038]
Draft Guidance for Industry: Preclinical
Assessment of Investigational Cellular
and Gene Therapy Products;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry: Preclinical
Assessment of Investigational Cellular
and Gene Therapy Products,’’ dated
November 2012. The draft guidance
document provides sponsors and
individuals that design and implement
preclinical studies with
recommendations on the substance and
scope of preclinical information needed
to support clinical trials for
investigational products regulated by
the Center for Biologics Research and
Evaluation (CBER), Office of Cellular,
Tissue, and Gene Therapies (OCTGT).
The product areas covered by this
guidance are cellular therapy, gene
therapy, therapeutic vaccination, and
xenotransplantation. The guidance is
intended to clarify current expectations
regarding the preclinical information
that supports an investigational new
drug application (IND) and a biologics
license application (BLA) for these
product areas.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by February 27,
2013.
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Submit written requests for
single copies of the draft guidance to the
Office of Communication, Outreach and
Development (HFM–40), CBER, Food
and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448. Send one selfaddressed adhesive label to assist the
office in processing your requests. The
draft guidance may also be obtained by
mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Tami Belouin, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry: Preclinical Assessment of
Investigational Cellular and Gene
Therapy Products,’’ dated November
2012. The draft guidance document
provides sponsors and individuals that
design and implement preclinical
studies with recommendations on the
substance and scope of preclinical
information needed to support clinical
trials for investigational products
regulated by OCTGT. The product areas
covered by this guidance are cellular
therapy, gene therapy, therapeutic
vaccination, and xenotransplantation.
The guidance is intended to clarify
current expectations regarding the
preclinical information that supports an
IND and a BLA for these product areas.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’s current thinking on this
topic. It does not create or confer any
rights for or on any person and does not
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operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the requirement
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 312 has
been approved under 0910–0014; the
collections of information in 21 CFR
part 601 has been approved under
0910–0338; and the collections of
information in 21 CFR part 58 has been
approved under 0910–0119.
III. Comments
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may
submit either written comments
regarding this document to the Division
of Dockets Management (see ADDRESSES)
or electronic comments to https://
www.regulations.gov. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: November 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–28882 Filed 11–28–12; 8:45 am]
BILLING CODE 4160–01–P
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]]>Agencies
[Federal Register Volume 77, Number 230 (Thursday, November 29, 2012)]
[Notices]
[Pages 71193-71194]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28907]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 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 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:
[[Page 71194]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of
21 CFR section No. of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
610.15............................................................. 1 1 1 1 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28907 Filed 11-28-12; 8:45 am]
BILLING CODE 4160-01-P
