Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Revision of the Requirements for Constituent Materials, 33845-33846 [2013-13247]
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33845
Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Notices
1. Considering the six priority areas
and related goals, please respond to the
following questions:
a. Are there critical gaps in viral
hepatitis activities which should be
given a major focus in a renewed Action
Plan? Provide background and rationale
for their inclusion. These gaps may have
been included in the 2011 Viral
Hepatitis Action Plan or they may be
new.
b. Are there effective models and best
practices that should be considered for
replication? Please include rationale for
their use in the field/area of viral
hepatitis.
2. What are the specific measures that
should be used to track progress of
implementation of the Viral Hepatitis
Action Plan and/or the progress of
addressing the epidemics of viral
hepatitis? Provide background and
rationale for the use of these measures.
3. What specific activities within and/
or components of the Affordable Care
Act offer substantial opportunities to
support improved viral hepatitis health
care services and data? Describe how
this might evolve.
4. How can government better engage
with non-governmental stakeholders
around the implementation of the
National Viral Hepatitis Action Plan?
Provide examples/suggestions of how
this could be integrated into a renewed
Action Plan and its implementation.
5. What additional information not
specifically addressed elsewhere in this
RFI that would be important for the
government to bear in mind in
developing a renewed National Viral
Hepatitis Action Plan?
Dated: May 21, 2013.
Ronald O. Valdiserri,
Deputy Assistant Secretary for Health,
Infectious Diseases, Office of the Assistant
Secretary for Health.
[FR Doc. 2013–13332 Filed 6–4–13; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0099]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 5,
2013.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0666. Also
include the FDA 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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Revision of the Requirements for
Constituent Materials—(OMB Control
Number 0910–0666)—Extension
In the Federal Register of April 13,
2011 (76 FR 20513), FDA issued a final
BILLING CODE 4150–28–P
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.
In the Federal Register of November
29, 2012 (77 FR 71193), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
mstockstill on DSK4VPTVN1PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
Number of
respondents
Number 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.
VerDate Mar<15>2010
16:43 Jun 04, 2013
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E:\FR\FM\05JNN1.SGM
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33846
Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Notices
Dated: May 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–13247 Filed 6–4–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0579]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Biological
Products: Reporting of Biological
Product Deviations and Human Cells,
Tissues, and Cellular and TissueBased Product Deviations in
Manufacturing; Forms FDA 3486 and
3486A
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 on
the information collection requirements
relating to the reporting of biological
product deviations in manufacturing
and human cells, tissues, and cellular
and tissue-based product (HCT/P)
deviations, and Forms FDA 3486 and
3486A.
Submit electronic or written
comments on the collection of
information by August 5, 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
Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
mstockstill on DSK4VPTVN1PROD with NOTICES
DATES:
VerDate Mar<15>2010
16:43 Jun 04, 2013
Jkt 229001
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.
Biological Products: Reporting of
Biological Product Deviations and
Human Cells, Tissues, and Cellular and
Tissue-Based Product Deviations in
Manufacturing; Forms FDA 3486 and
3486A (OMB Control Number 0910–
0458)—Extension
Under section 351 of the Public
Health Service Act (PHS Act) (42 U.S.C.
262), all biological products, including
human blood and blood components,
offered for sale in interstate commerce
must be licensed and meet standards,
including those prescribed in the FDA
regulations, designed to ensure the
continued safety, purity, and potency of
such products. In addition under
section 361 of the PHS Act (42 U.S.C.
264), FDA may issue and enforce
regulations necessary to prevent the
introduction, transmission, or spread of
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
communicable diseases between the
States or possessions or from foreign
countries into the States or possessions.
Further, the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
351) provides that drugs and devices
(including human blood and blood
components) are adulterated if they do
not conform with current good
manufacturing practice (CGMP) assuring
that they meet the requirements of the
FD&C Act. Establishments
manufacturing biological products,
including human blood and blood
components, must comply with the
applicable CGMP regulations (parts 211,
606, and 820 (21 CFR parts 211, 606,
and 820)) and current good tissue
practice (CGTP) regulations (part 1271
(21 CFR part 1271)) as appropriate. FDA
regards biological product deviation
(BPD) reporting and HCT/P deviation
reporting to be an essential tool in its
directive to protect public health by
establishing and maintaining
surveillance programs that provide
timely and useful information.
Section 600.14 (21 CFR 600.14), in
brief, requires the manufacturer who
holds the biological product license, for
other than human blood and blood
components, and who had control over
a distributed product when the
deviation occurred, to report to the
Center for Biologics Evaluation and
Research (CBER) or to the Center for
Drugs Evaluation and Research (CDER)
as soon as possible but at a date not to
exceed 45 calendar days after acquiring
information reasonably suggesting that a
reportable event has occurred. Section
606.171, in brief, requires licensed
manufacturers of human blood and
blood components, including Source
Plasma, unlicensed registered blood
establishments, and transfusion
services, who had control over a
distributed product when the deviation
occurred, to report to CBER as soon as
possible but at a date not to exceed 45
calendar days after acquiring
information reasonably suggesting that a
reportable event has occurred.
Similarly, § 1271.350(b), in brief,
requires HCT/P establishments that
manufacture non-reproductive HCT/Ps
described in § 1271.10 to investigate and
report to CBER all HCT/P deviations
relating to a distributed HCT/P that
relates to the core CGTP requirements,
if the deviation occurred in the
establishment’s facility or in a facility
that performed a manufacturing step for
the establishment under contract,
agreement or other arrangement. Form
FDA 3486 is used to submit BPD reports
and HCT/P deviation reports.
Respondents to this collection of
information are the licensed
E:\FR\FM\05JNN1.SGM
05JNN1
]]>Agencies
[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Notices]
[Pages 33845-33846]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13247]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0099]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by July 5,
2013.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0666.
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Revision of the Requirements for Constituent Materials--(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.
In the Federal Register of November 29, 2012 (77 FR 71193), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number 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.
[[Page 33846]]
Dated: May 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13247 Filed 6-4-13; 8:45 am]
BILLING CODE 4160-01-P
