81 FR 41553 - Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment; Draft Guidance for Industry; Extension of the Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 123 (June 27, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 123 (June 27, 2016)
| Page Range | 41553-41554 | |
| FR Document | 2016-15098 |
[Federal Register Volume 81, Number 123 (Monday, June 27, 2016)] [Notices] [Pages 41553-41554] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-15098] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1170] Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment; Draft Guidance for Industry; Extension of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of the comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is extending the comment period for the notice of availability, published in the Federal Register of May 4, 2016 (81 FR 26805), announcing the draft guidance for industry entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.'' We are taking this action due to maintenance on the Federal eRulemaking portal from July 1 through July 5, 2016. DATES: Submit either electronic or written comments by July 19, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are [[Page 41554]] solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2013-D-1170 for ``Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment; Draft Guidance for Industry.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 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: In the Federal Register of May 4, 2016 (81 FR 26805), FDA published a notice of availability. Interested persons were originally given until July 5, 2016, to comment on the draft guidance for industry entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.'' From July 1 through July 5, 2016, the Federal eRulemaking Portal, http://www.regulations.gov, is undergoing maintenance. We are, therefore, extending the comment period for the draft guidance for industry entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.'' The extended comment period will close on July 19, 2016. Dated: June 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-15098 Filed 6-24-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 123 / Monday, June 27, 2016 / Notices 41553
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Recognition No. Title of standard 1 Reference No. and date
H. Software/Informatics
13–82 ...................... Application of risk management for IT networks incorporating medical—Applica- AAMI/ISO TIR 80001–2–6:2014.
tion guidance—Part 2–6: Guidance for responsibility agreements.
13–83 ...................... Principles for medical device security—Risk management ................................... AAMI TIR 57:2016.
13–84 ...................... Health informatics—Point-of-care medical device communication—Part 10103: ISO/IEEE 11073–10103 First edition
Nomenclature—Implantable device, cardiac. 2014–03–01.
I. Tissue Engineering
15–45 ...................... Medical devices utilizing animal tissues and their derivatives—Part 1: Applica- ISO 22442–1 Second edition 2015–11–
tion of risk management. 1.
15–46 ...................... Medical devices utilizing animal tissues and their derivatives—Part 2: Controls ISO 22442–2 Second edition 2015–11–
on sourcing, collection and handling. 1.
15–47 ...................... Medical devices utilizing animal tissues and their derivatives—Part 3: Validation ISO 22442–3 First edition 2007–12–15.
of the elimination and/or inactivation of viruses and transmissible spongiform
encephalopathy (TSE) agents.
1 All standard titles in this table conform to the style requirements of the respective organizations.
IV. List of Recognized Standards identification of the testing or DEPARTMENT OF HEALTH AND
FDA maintains the Agency’s current performance or other characteristics of HUMAN SERVICES
list of FDA Recognized Consensus the device(s) that would be addressed
Standards in a searchable database that by a declaration of conformity. Food and Drug Administration
may be accessed directly at FDA’s VI. Electronic Access [Docket No. FDA–2013–D–1170]
Internet site at http://
www.accessdata.fda.gov/scripts/cdrh/ You may obtain a copy of ‘‘Guidance Chronic Hepatitis C Virus Infection:
cfdocs/cfStandards/search.cfm. FDA on the Recognition and Use of Developing Direct-Acting Antiviral
will incorporate the modifications and Consensus Standards’’ by using the Drugs for Treatment; Draft Guidance
revisions described in this notice into Internet. The Center for Devices and for Industry; Extension of the
the database and, upon publication in Radiological Health (CDRH) maintains a Comment Period
the Federal Register, this recognition of site on the Internet for easy access to
consensus standards will be effective. AGENCY: Food and Drug Administration,
information including text, graphics, HHS.
FDA will announce additional
and files that you may download to a Notice; extension of the
ACTION:
modifications and revisions to the list of
personal computer with access to the comment period.
recognized consensus standards, as
needed, in the Federal Register once a Internet. Updated on a regular basis, the
CDRH home page, http://www.fda.gov/ SUMMARY: The Food and Drug
year, or more often if necessary.
MedicalDevices, includes a link to Administration (FDA or we) is
Beginning with Recognition List 033,
standards-related documents including extending the comment period for the
FDA no longer announces minor
the guidance and the current list of notice of availability, published in the
revisions to the list of recognized
recognized standards. After publication Federal Register of May 4, 2016 (81 FR
consensus standards such as technical
in the Federal Register, this notice 26805), announcing the draft guidance
contact person, devices affected,
announcing ‘‘Modification to the List of for industry entitled ‘‘Chronic Hepatitis
processes affected, Code of Federal
Recognized Standards, Recognition List C Virus Infection: Developing Direct-
Regulations citations, and product
Number: 043’’ will be available at http:// Acting Antiviral Drugs for Treatment.’’
codes.
We are taking this action due to
www.fda.gov/MedicalDevices/
V. Recommendation of Standards for maintenance on the Federal
DeviceRegulationandGuidance/
Recognition by FDA eRulemaking portal from July 1 through
Standards/ucm123792.htm. You may July 5, 2016.
Any person may recommend access ‘‘Guidance on the Recognition
consensus standards as candidates for DATES: Submit either electronic or
and Use of Consensus Standards,’’ and
recognition under section 514 of the written comments by July 19, 2016.
the searchable database for ‘‘FDA
FD&C Act by submitting such Recognized Consensus Standards’’ at ADDRESSES: You may submit comments
recommendations, with reasons for the as follows:
http://www.fda.gov/MedicalDevices/
recommendation, to standards@
DeviceRegulationandGuidance/ Electronic Submissions
cdrh.fda.gov. To be properly considered,
Standards.
such recommendations should contain, Submit electronic comments in the
at a minimum, the following Dated: June 21, 2016. following way:
information: (1) Title of the standard, (2) Leslie Kux, • Federal eRulemaking Portal: http://
mstockstill on DSK3G9T082PROD with NOTICES
any reference number and date, (3) Associate Commissioner for Policy. www.regulations.gov. Follow the
name and address of the national or [FR Doc. 2016–15100 Filed 6–24–16; 8:45 am]
instructions for submitting comments.
international standards development Comments submitted electronically,
BILLING CODE 4164–01–P
organization, (4) a proposed list of including attachments, to http://
devices for which a declaration of www.regulations.gov will be posted to
conformity to this standard should the docket unchanged. Because your
routinely apply, and (5) a brief comment will be made public, you are
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![41554 Federal Register / Vol. 81, No. 123 / Monday, June 27, 2016 / Notices
solely responsible for ensuring that your copies to the Division of Dockets DEPARTMENT OF HEALTH AND
comment does not include any Management. If you do not wish your HUMAN SERVICES
confidential information that you or a name and contact information to be
third party may not wish to be posted, made publicly available, you can Health Resources and Services
such as medical information, your or provide this information on the cover Administration
anyone else’s Social Security number, or sheet and not in the body of your
confidential business information, such Agency Information Collection
comments and you must identify this Activities: Submission to OMB for
as a manufacturing process. Please note information as ‘‘confidential.’’ Any
that if you include your name, contact Review and Approval; Public Comment
information marked as ‘‘confidential’’ Request
information, or other information that will not be disclosed except in
identifies you in the body of your AGENCY: Health Resources and Services
accordance with 21 CFR 10.20 and other
comments, that information will be Administration, HHS.
posted on http://www.regulations.gov. applicable disclosure law. For more
information about FDA’s posting of ACTION: Notice.
• If you want to submit a comment
with confidential information that you comments to public dockets, see 80 FR SUMMARY: In compliance with section
do not wish to be made available to the 56469, September 18, 2015, or access 3507(a)(1)(D) of the Paperwork
public, submit the comment as a the information at: http://www.fda.gov/ Reduction Act of 1995, the Health
written/paper submission and in the regulatoryinformation/dockets/ Resources and Services Administration
manner detailed (see ‘‘Written/Paper default.htm. (HRSA) has submitted an Information
Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to Collection Request (ICR) to the Office of
Written/Paper Submissions read background documents or the Management and Budget (OMB) for
electronic and written/paper comments review and approval. Comments
Submit written/paper submissions as submitted during the first public review
follows: received, go to http://
www.regulations.gov and insert the of this ICR will be provided to OMB.
• Mail/Hand delivery/Courier (for
docket number, found in brackets in the OMB will accept further comments from
written/paper submissions): Division of
heading of this document, into the the public during the review and
Dockets Management (HFA–305), Food
‘‘Search’’ box and follow the prompts approval period.
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets DATES: Comments on this ICR should be
• For written/paper comments Management, 5630 Fishers Lane, Rm. received no later than July 27, 2016.
submitted to the Division of Dockets 1061, Rockville, MD 20852. ADDRESSES: Submit your comments,
Management, FDA will post your including the ICR Title, to the desk
FOR FURTHER INFORMATION CONTACT: officer for HRSA, either by email to
comment, as well as any attachments,
except for information submitted, Jeffrey Murray, Center for Drug OIRA_submission@omb.eop.gov or by
marked and identified, as confidential, Evaluation and Research, Food and fax to 202–395–5806.
if submitted as detailed in Drug Administration, 10903 New FOR FURTHER INFORMATION CONTACT: To
‘‘Instructions.’’ Hampshire Ave., Bldg. 22, Rm. 6360, request a copy of the clearance requests
Instructions: All submissions received Silver Spring, MD 20993–0002, 301– submitted to OMB for review, email the
must include the Docket No. FDA– 796–1500. HRSA Information Collection Clearance
2013–D–1170 for ‘‘Chronic Hepatitis C SUPPLEMENTARY INFORMATION: In the Officer at paperwork@hrsa.gov or call
Virus Infection: Developing Direct- Federal Register of May 4, 2016 (81 FR (301) 443–1984.
Acting Antiviral Drugs for Treatment; SUPPLEMENTARY INFORMATION:
26805), FDA published a notice of
Draft Guidance for Industry.’’ Received Information Collection Request Title:
availability.
comments will be placed in the docket Black Lung Clinics Program
and, except for those submitted as Interested persons were originally Performance Measures OMB No. 0915–
‘‘Confidential Submissions,’’ publicly given until July 5, 2016, to comment on 0292–Extension
viewable at http://www.regulations.gov the draft guidance for industry entitled Abstract: HRSA’s Federal Office of
or at the Division of Dockets ‘‘Chronic Hepatitis C Virus Infection: Rural Health Policy (FORHP), conducts
Management between 9 a.m. and 4 p.m., Developing Direct-Acting Antiviral an annual data collection of information
Monday through Friday. Drugs for Treatment.’’ for the Black Lung Clinics Program,
• Confidential Submissions—To From July 1 through July 5, 2016, the which has been ongoing with OMB
submit a comment with confidential approval since 2004. The Black Lung
Federal eRulemaking Portal, http://
information that you do not wish to be Clinics Program seeks to reduce the
www.regulations.gov, is undergoing
made publicly available, submit your morbidity and mortality associated with
comments only as a written/paper maintenance. We are, therefore,
occupationally-related coal mine dust
submission. You should submit two extending the comment period for the
lung disease. Collecting this data
copies total. One copy will include the draft guidance for industry entitled provides HRSA with information on the
information you claim to be confidential ‘‘Chronic Hepatitis C Virus Infection: extent to which each grantee is meeting
with a heading or cover note that states Developing Direct-Acting Antiviral the needs of these miners in their
‘‘THIS DOCUMENT CONTAINS Drugs for Treatment.’’ The extended communities.
CONFIDENTIAL INFORMATION.’’ The comment period will close on July 19, Need and Proposed Use of the
Agency will review this copy, including 2016. Information: Data from the annual
mstockstill on DSK3G9T082PROD with NOTICES
the claimed confidential information, in Dated: June 21, 2016. report provides quantitative information
its consideration of comments. The Leslie Kux,
about the clinics, specifically: (a) The
second copy, which will have the characteristics of the patients they serve
Associate Commissioner for Policy.
claimed confidential information (gender, age, disability level, occupation
redacted/blacked out, will be available [FR Doc. 2016–15098 Filed 6–24–16; 8:45 am] type); (b) the characteristics of services
for public viewing and posted on http:// BILLING CODE 4164–01–P provided (medical encounters, non-
www.regulations.gov. Submit both medical encounters, benefits
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Document Created: 2016-06-25 02:06:52
Document Modified: 2016-06-25 02:06:52
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; extension of the comment period. | |
| Dates | Submit either electronic or written comments by July 19, 2016. | |
| 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. | |
| FR Citation | 81 FR 41553 |
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