Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment; Availability, 63218-63219 [2013-24785]

Download as PDF 63218 Federal Register / Vol. 78, No. 205 / Wednesday, October 23, 2013 / Notices FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR 170.39 No. of respondents No. of responses per respondent Total annual responses Average burden per response Total hours Threshold of regulation for substances used in food-contact articles ....................................................................... 7 1 7 48 336 emcdonald on DSK67QTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. In compiling these estimates, FDA consulted its records of the number of regulation exemption requests received in the past three years. The annual hours per response reporting estimate of 48 hours is based on information received from representatives of the food packaging and processing industries and Agency records. FDA estimates that approximately 7 requests per year will be submitted under the threshold of regulation exemption process of § 170.39, for a total of 336 hours. The threshold of regulation process offers one advantage over the premarket notification process for food-contact substances established by section 409(h) (OMB control number 0910–0495) in that the use of a substance exempted by the Agency is not limited to only the manufacturer or supplier who submitted the request for an exemption. Other manufacturers or suppliers may use exempted substances in food-contact articles as long as the conditions of use (e.g., use levels, temperature, type of food contacted, etc.) are those for which the exemption was issued. As a result, the overall burden on both the Agency and the regulated industry would be significantly less in that other manufacturers and suppliers would not have to prepare, and FDA would not have to review, similar submissions for identical components of food-contact articles used under identical conditions. Manufacturers and other interested persons can easily access an up-to-date list of exempted substances which is on display at FDA’s Division of Dockets Management and on the Internet at https://www.fda.gov/Food/Ingredients PackagingLabeling/PackagingFCS/ default.htm. Having the list of exempted substances publicly available decreases the likelihood that a company would submit a food additive petition or a notification for the same type of foodcontact application of a substance for which the Agency has previously granted an exemption from the food additive listing regulation requirement. VerDate Mar<15>2010 18:13 Oct 22, 2013 Jkt 232001 Dated: October 17, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–24804 Filed 10–22–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–1170] Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Chronic Hepatitis C Virus Infection: Developing DirectActing Antiviral Drugs for Treatment.’’ The purpose of this guidance is to assist sponsors in all phases of development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C. This guidance revises and replaces a previous draft guidance for industry entitled ‘‘Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment’’ issued on September 14, 2010. 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 December 23, 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 SUMMARY: PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 one self-addressed adhesive label to assist that office in processing your requests. 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: Jeffrey Murray, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6360, Silver Spring, MD 20993–0002, 301– 796–1500. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.’’ The purpose of this guidance is to assist sponsors in all phases of development of DAA drugs for the treatment of chronic hepatitis C. This guidance revises the draft guidance for industry entitled ‘‘Chronic Hepatitis C Virus Infection: Developing DirectActing Antiviral Agents for Treatment’’ issued in September 2010. Significant changes in this revision include: • Details on phase 2 and phase 3 trial design options for the evaluation of interferon (IFN)-free and IFN-containing ¨ regimens in treatment-naıve and treatment-experienced populations, including DAA-experienced populations. • Revised primary endpoint to sustained virologic response at 12 weeks post-treatment cessation. • Greater emphasis on DAA drug development in special populations including trial design options for human immunodeficiency virus/hepatitis C virus co-infected patients, patients with decompensated cirrhosis, and patients pre- or post-liver transplant. • More details on clinical virology considerations for DAA drugs. E:\FR\FM\23OCN1.SGM 23OCN1 Federal Register / Vol. 78, No. 205 / Wednesday, October 23, 2013 / Notices 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 developing DAA drugs for the treatment of chronic hepatitis C virus infection. 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 guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget 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, the collections of information in 21 CFR part 314 have been approved under OMB control number 0910–0001, and the collections of information referred to in the guidance for industry ‘‘Establishment and Operation of Clinical Trial Data Monitoring Committees’’ have been approved under OMB control number 0910–0581. 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. emcdonald on DSK67QTVN1PROD with NOTICES IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/Guidances/default.htm or https://www.regulations.gov. Dated: October 4, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–24785 Filed 10–22–13; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 18:13 Oct 22, 2013 Jkt 232001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–1156] International Conference on Harmonisation; Draft Guidance on Elemental Impurities; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘Elemental Impurities.’’ Prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), this guidance is intended to develop a harmonized approach for the control of elemental impurities that helps industry avoid the uncertainty and duplication of work resulting from differing requirements across ICH regions. It includes the specific elements to be limited and the appropriate limits for impurities, and emphasizes control of supply chains and risk assessments. It is expected to provide appropriate safety-based limits for the control of elemental impurities, consistent expectations for test requirements and regulatory filings, and a global policy for limiting elemental impurities, both qualitatively and quantitatively, in drug products and ingredients. SUMMARY: 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 December 23, 2013. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002, or the 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 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 DATES: PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 63219 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: Regarding the guidance: John Kauffman, CDER, Food and Drug Administration, 1114 Market St., DPA Facility, suite 1002, St. Louis, MO 63101, 314–539– 2135. Regarding the ICH: Michelle Limoli, International Programs, CDER, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3342, Silver Spring, MD 20993–0002, 301–796–8377. SUPPLEMENTARY INFORMATION: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; CDER and CBER, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as E:\FR\FM\23OCN1.SGM 23OCN1

Agencies

[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Notices]
[Pages 63218-63219]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24785]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1170]


Draft Guidance for Industry on Chronic Hepatitis C Virus 
Infection: Developing Direct-Acting Antiviral Drugs for Treatment; 
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 ``Chronic 
Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs 
for Treatment.'' The purpose of this guidance is to assist sponsors in 
all phases of development of direct-acting antiviral (DAA) drugs for 
the treatment of chronic hepatitis C. This guidance revises and 
replaces a previous draft guidance for industry entitled ``Chronic 
Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents 
for Treatment'' issued on September 14, 2010.

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 December 23, 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 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: Jeffrey Murray, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6360, Silver Spring, MD 20993-0002, 301-
796-1500.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-
Acting Antiviral Drugs for Treatment.'' The purpose of this guidance is 
to assist sponsors in all phases of development of DAA drugs for the 
treatment of chronic hepatitis C. This guidance revises the draft 
guidance for industry entitled ``Chronic Hepatitis C Virus Infection: 
Developing Direct-Acting Antiviral Agents for Treatment'' issued in 
September 2010. Significant changes in this revision include:
     Details on phase 2 and phase 3 trial design options for 
the evaluation of interferon (IFN)-free and IFN-containing regimens in 
treatment-na[iuml]ve and treatment-experienced populations, including 
DAA-experienced populations.
     Revised primary endpoint to sustained virologic response 
at 12 weeks post-treatment cessation.
     Greater emphasis on DAA drug development in special 
populations including trial design options for human immunodeficiency 
virus/hepatitis C virus co-infected patients, patients with 
decompensated cirrhosis, and patients pre- or post-liver transplant.
     More details on clinical virology considerations for DAA 
drugs.

[[Page 63219]]

    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 developing 
DAA drugs for the treatment of chronic hepatitis C virus infection. 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 guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget 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, the collections of information in 
21 CFR part 314 have been approved under OMB control number 0910-0001, 
and the collections of information referred to in the guidance for 
industry ``Establishment and Operation of Clinical Trial Data 
Monitoring Committees'' have been approved under OMB control number 
0910-0581.

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: October 4, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-24785 Filed 10-22-13; 8:45 am]
BILLING CODE 4160-01-P
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