Draft Guidance for Industry on Attachment to Guidance on Antiviral Product Development-Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting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]

Download as PDF 12759 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 http:// 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 http://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 http:// 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 http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http://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 http://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]


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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 http://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 http://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 http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://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