Draft Guidance for Industry on Attachment to Guidance on Antiviral Product Development-Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting Hepatitis C Virus Resistance Data; Availability, 12759-12760 [2013-04196]
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Federal Register / Vol. 78, No. 37 / Monday, February 25, 2013 / Notices
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: ACF Reports Clearance
Officer. Email address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2013–04176 Filed 2–22–13; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: State Self-Assessment Review
and Report.
OMB No.: 0970–0223.
Description: Section 454(15)(A) of the
Social Security Act, as amended by the
Personal Responsibility and Work
Opportunity Reconciliation Act of 1996,
requires each State to annually assess
the performance of its child support
enforcement program in accordance
with standards specified by the
Secretary of the Department of Health
and Human Services, and to provide a
report of the findings to the Secretary.
This information is required to
determine if States are complying with
Federal child support mandates and
providing the best services possible. The
report is also intended to be used as a
management tool to help States evaluate
their programs and assess performance.
Respondents: State Child Support
Enforcement Agencies or the
Department/Agency/Bureau responsible
for Child Support Enforcement in each
State.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of responses per
respondent
Average burden hours
per response
Total burden
hours
Self-assessment report ....................................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Instrument
54
1
4
216
Estimated Total Annual Burden
Hours: 216.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
VerDate Mar<15>2010
17:22 Feb 22, 2013
Jkt 229001
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2013–04278 Filed 2–22–13; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2005–D–0282; formerly
2005D–0183]
Draft Guidance for Industry on
Attachment to Guidance on Antiviral
Product Development—Conducting
and Submitting Virology Studies to the
Agency: Guidance for Submitting
Hepatitis C Virus Resistance Data;
Availability
AGENCY:
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Attachment to
Guidance on Antiviral Product
Development—Conducting and
Submitting Virology Studies to the
SUMMARY:
PO 00000
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 April 26, 2013.
DATES:
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
ADDRESSES:
HHS.
ACTION:
Agency: Guidance for Submitting HCV
Resistance Data.’’ The purpose of this
attachment is to assist sponsors in
submitting hepatitis C virus (HCV)
clinical virology data, which are
important for supporting clinical trials
of products in development for the
treatment of HCV. HCV resistance data
submitted in appropriately formatted
datasets is a critical component in the
review of investigational antiviral
products for the treatment of HCV. The
information in this attachment will
facilitate the development and
regulatory review of anti-HCV products.
Frm 00046
Fmt 4703
Sfmt 4703
E:\FR\FM\25FEN1.SGM
25FEN1
12760
Federal Register / Vol. 78, No. 37 / Monday, February 25, 2013 / Notices
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.
Lisa
K. Naeger, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, rm. 6366, Silver Spring,
MD 20993–0002, 301–796–0771.
FOR FURTHER INFORMATION CONTACT:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Attachment to Guidance on Antiviral
Product Development—Conducting and
Submitting Virology Studies to the
Agency: Guidance for Submitting HCV
Resistance Data.’’ The purpose of this
attachment is to assist sponsors in
submitting HCV clinical virology data,
which are important for supporting
clinical trials of products in
development for the treatment of HCV.
This attachment revises and replaces the
attachment on submitting HCV
resistance data published in June 2006
and represents FDA’s current thinking
regarding how sponsors should submit
HCV resistance data. The revised
attachment provides the format,
recommended definitions,
standardization of column headings and
variables, and recommended data for
submission of HCV resistance datasets.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on submitting HCV clinical virology
data. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
mstockstill on DSK4VPTVN1PROD with NOTICES
II. The Paperwork Reduction Act of
1995
This draft guidance refers to
previously approved collections of
information that 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 have been approved under
OMB control number 0910–0014.
17:22 Feb 22, 2013
Jkt 229001
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). 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
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
III. Comments
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://www.
regulations.gov.
Dated: February 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–04196 Filed 2–22–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2005–D–0153; formerly
2005D–0011]
Guidance for Industry on Labeling for
Human Prescription Drug and
Biological Products—Implementing the
Physician Labeling Rule Content and
Format Requirements; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Labeling for Human
Prescription Drug and Biological
Products—Implementing the PLR
Content and Format Requirements.’’
This guidance is intended to assist
applicants in complying with the
content and format requirements of
labeling for human prescription drug
and biological products. The
recommendations in this guidance will
help ensure that the labeling is clear;
useful; informative; and to the extent
possible, consistent in content and
format. It will assist applicants in
developing labeling for new products,
revising existing labeling, and
implementing the requirements on
content and format of labeling for
SUMMARY:
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
human prescription drug and biological
products (71 FR 3922), which appeared
in the Federal Register of January 24,
2006. The rule is commonly referred to
as the ‘‘Physician Labeling Rule’’ (PLR)
because it addresses prescription drug
labeling that is used by prescribers and
other health care practitioners.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002 or Office
of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
that office in processing your requests.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
guidance document.
Submit electronic comments on the
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: Lori
Bickel, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6353, Silver Spring,
MD 20993–0002, 301–796–0210; or
Stephen Ripley, 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:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Labeling for Human Prescription Drug
and Biological Products—Implementing
the PLR Content and Format
Requirements.’’ The guidance provides
recommendations on how to create
professional labeling consistent with the
requirements on content and format of
labeling for human prescription drug
and biological products under §§ 201.56
and 201.57 (21 CFR 201.56 and 201.57)
(71 FR 3922). The guidance also
provides recommendations on how to
organize labeling sections and what
information should be included in each.
This guidance is one of a series of
guidances FDA is developing, or has
E:\FR\FM\25FEN1.SGM
25FEN1
]]>Agencies
[Federal Register Volume 78, Number 37 (Monday, February 25, 2013)]
[Notices]
[Pages 12759-12760]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04196]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2005-D-0282; formerly 2005D-0183]
Draft Guidance for Industry on Attachment to Guidance on
Antiviral Product Development--Conducting and Submitting Virology
Studies to the Agency: Guidance for Submitting Hepatitis C Virus
Resistance Data; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Attachment to
Guidance on Antiviral Product Development--Conducting and Submitting
Virology Studies to the Agency: Guidance for Submitting HCV Resistance
Data.'' The purpose of this attachment is to assist sponsors in
submitting hepatitis C virus (HCV) clinical virology data, which are
important for supporting clinical trials of products in development for
the treatment of HCV. HCV resistance data submitted in appropriately
formatted datasets is a critical component in the review of
investigational antiviral products for the treatment of HCV. The
information in this attachment will facilitate the development and
regulatory review of anti-HCV products.
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 April 26, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY
[[Page 12760]]
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: Lisa K. Naeger, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-0771.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Attachment to Guidance on Antiviral Product Development--
Conducting and Submitting Virology Studies to the Agency: Guidance for
Submitting HCV Resistance Data.'' The purpose of this attachment is to
assist sponsors in submitting HCV clinical virology data, which are
important for supporting clinical trials of products in development for
the treatment of HCV. This attachment revises and replaces the
attachment on submitting HCV resistance data published in June 2006 and
represents FDA's current thinking regarding how sponsors should submit
HCV resistance data. The revised attachment provides the format,
recommended definitions, standardization of column headings and
variables, and recommended data for submission of HCV resistance
datasets.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on submitting
HCV clinical virology data. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
II. The Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information that 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 have been
approved under OMB control number 0910-0014.
III. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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 document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: February 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04196 Filed 2-22-13; 8:45 am]
BILLING CODE 4160-01-P
