82 FR 2367 - Submission of Quality Metrics Data; Revised Draft Guidance for Industry; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 5 (January 9, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 5 (January 9, 2017)
| Page Range | 2367-2368 | |
| FR Document | 2017-00094 |
[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)] [Notices] [Pages 2367-2368] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00094] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-2537] Submission of Quality Metrics Data; Revised Draft Guidance for Industry; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; extension of comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is extending the comment period for the notice of revised draft guidance availability that appeared in the Federal Register of November 25, 2016. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the notice of revised draft guidance availability published on November 25, 2016 (81 FR 85226). Submit either electronic or written comments by March 27, 2017. [[Page 2368]] ADDRESSES: You may submit comments by any of the following methods: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are 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 https://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 Submissions Submit written submissions in the following ways: 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-2015-D-2537 for ``Submission of Quality Metrics Data; Revised Draft Guidance for Industry.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://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 https://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 https://www.regulations.gov and insert the docket number(s), 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: Tara Gooen Bizjak, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2109, Silver Spring, MD 20993-0002, 301- 796-3257 or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: In the Federal Register of November 25, 2016, FDA published a notice of revised draft guidance availability with a 60-day comment period. Comments on the notice of revised draft guidance availability will inform FDA's development and proposed implementation of a voluntary phase of the quality metrics program. FDA is extending the comment period for an additional 60 days, until March 27, 2017. The Agency believes that a 60-day extension of the comment period for the notice of revised draft guidance availability will provide adequate time for interested persons to submit comments without significantly delaying Agency decision making on these important issues. Dated: January 3, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-00094 Filed 1-6-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices 2367
tribes.’’ Finally, ACF recently issued the as well as provide as much detail as specific, including recommended use of
ACF Principles for Working with possible in describing challenges or technological or other means of data
Federally Recognized Indian Tribes, difficulties posed and any specific sharing.
effective October 20, 2016, that affirmed recommendations you wish to provide. (9) Are there elements of the
ACF’s commitment to receive input (2) Are there challenges to AI/AN application process that could
from elected tribal representatives as tribes and tribal organizations posed by potentially discourage AI/AN tribes or
well as ‘‘to otherwise ensure human administrative cost caps required under organizations from applying for ACF
services coordination around issues some ACF grant programs? Please be grants? If so, please specify what those
affecting AI/AN populations.’’ specific as to the program or programs elements are and explain why those
Consistent with the above affirmative you are referring to as well as provide elements could potentially discourage
statements of the value of feedback from as much detail as possible in describing prospective AI/AN applicants and any
AI/AN partners and stakeholders, ACF challenges or difficulties posed and any recommendations for addressing such
is requesting information from AI/AN specific recommendations you wish to barriers.
tribes, tribal organizations, and provide.
stakeholders (including grantees). The (3) Are there instances for which you III. Response to Comments
purpose is to identify issues and believe waiver authority, additional Because of the large number of public
challenges facing AI/AN populations as waiver authority allowed under block comments we normally receive, we are
well as to inform ACF of tribes’ and grants, would benefit tribes under any not able to acknowledge or respond to
tribal organizations’ recommendations, ACF programs? Please be specific as to them individually. However, comments
promising practices, and innovations to the program or programs you are will be accepted on this RFI through
address the needs of AI/AN children, referring to as well as provide as much https://www.Regulations.gov where you
youth, families, and communities. This detail as possible in describing will be able to track your own
information may, in turn, be used by challenges or difficulties posed and any comments and view other comments we
ACF in the development of future specific recommendations you wish to receive.
rulemaking and technical assistance, provide.
(4) For ACF programs that currently Dated: January 3, 2017.
formation of legislative proposals and
have waiver authority for tribes, do you Mark H. Greenberg
research agendas, and strategic planning
in consultation with tribes. recommend ACF streamline the Acting Assistant Secretary for Children and
processes under which AI/AN tribes Families.
II. Request for Information and tribal organizations apply for or Dated: January 3, 2017.
As President Obama stated in his request waivers of statutory or Stacey Ecoffey,
Presidential Proclamation—National regulatory requirements across ACF Acting Deputy Assistant Secretary for Native
Native American Heritage Month (2016): grant programs? Please be specific as to American Affairs and Acting Commissioner
the program or programs you are Administration for Native Americans.
Let us continue to build on the
advancements we have made, because referring to as well as provide as much [FR Doc. 2017–00111 Filed 1–6–17; 8:45 am]
enduring progress will depend on our detail as possible in describing where BILLING CODE 4184–01–P
dedication to honoring our trust and treaty you believe additional streamlining is
responsibilities. With sustained effort and needed, along with any specific
unwavering optimism, we can ensure a recommendations you wish to provide. DEPARTMENT OF HEALTH AND
vibrant and resilient Indian Country filled (5) Are there regulatory or HUMAN SERVICES
with possibility and prosperity.
administrative barriers that present
In this RFI, we seek feedback and challenges to AI/AN tribes and tribal Food and Drug Administration
recommendations related to how ACF organizations in the implementation of [Docket No. FDA–2015–D–2537]
partners with tribes and how to make ACF grant programs? Please be specific
progress in the future. The following about what those regulatory or Submission of Quality Metrics Data;
questions are not exhaustive, and we administrative barriers are as well as Revised Draft Guidance for Industry;
encourage commenters to provide any recommendations for addressing them. Extension of Comment Period
additional information they believe (6) Can you identify practices,
relevant to ACF’s work with and on policies, and procedures in ACF or AGENCY: Food and Drug Administration,
behalf of American Indians and Alaska elsewhere that are particularly effective HHS.
Natives. You may provide general in meeting the needs of AI/AN tribes, ACTION:Notice of availability; extension
comments, respond to all questions tribal organizations, families, and of comment period.
posed in section II of this RFI, or communities? Please be specific as to
respond to one or more questions. If you the program or programs you are SUMMARY: The Food and Drug
respond to any of the questions in referring to as well as provide as much Administration (FDA) is extending the
section II, please identify the number detail as possible in describing effective comment period for the notice of
that corresponds to the question(s) you and responsive practices, policies, and revised draft guidance availability that
are responding to. Include our agency procedures. appeared in the Federal Register of
name and the docket number on all (7) Related to data, what would you November 25, 2016. The Agency is
submissions. Please do not include recommend ACF either collect (if it does taking this action in response to
confidential information, or otherwise not already) or analyze that would be requests for an extension to allow
interested persons additional time to
sradovich on DSK3GMQ082PROD with NOTICES
sensitive or protected information with most useful to inform our work with
your responses. AI/AN tribes and tribal organizations? submit comments.
(1) Are there challenges to AI/AN Please be specific and provide as much DATES: FDA is extending the comment
tribes and tribal organizations posed by detail as possible. period on the notice of revised draft
non-federal match or cost sharing (8) Do you have recommendations for guidance availability published on
requirements in any applicable ACF how ACF could better share data related November 25, 2016 (81 FR 85226).
programs? Please be specific as to the to AI/AN grantee program performance, Submit either electronic or written
program or programs you are referring to outcomes, and sustainability? Please be comments by March 27, 2017.
VerDate Sep<11>2014 21:14 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\09JAN1.SGM 09JAN1](https://thefederalregister.org/doc/82_FR_2372/page/1.svg)
![2368 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices
ADDRESSES: You may submit comments copies total. One copy will include the the notice of revised draft guidance
by any of the following methods: information you claim to be confidential availability will provide adequate time
with a heading or cover note that states for interested persons to submit
Electronic Submissions
‘‘THIS DOCUMENT CONTAINS comments without significantly
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The delaying Agency decision making on
following way: Agency will review this copy, including these important issues.
• Federal eRulemaking Portal: the claimed confidential information, in Dated: January 3, 2017.
https://www.regulations.gov. Follow the its consideration of comments. The
instructions for submitting comments. Leslie Kux,
second copy, which will have the
Comments submitted electronically, Associate Commissioner for Policy.
claimed confidential information
including attachments, to https:// [FR Doc. 2017–00094 Filed 1–6–17; 8:45 am]
redacted/blacked out, will be available
www.regulations.gov will be posted to for public viewing and posted on BILLING CODE 4164–01–P
the docket unchanged. Because your https://www.regulations.gov. Submit
comment will be made public, you are both copies to the Division of Dockets
solely responsible for ensuring that your DEPARTMENT OF HEALTH AND
Management. If you do not wish your
comment does not include any HUMAN SERVICES
name and contact information to be
confidential information that you or a made publicly available, you can
third party may not wish to be posted, Food and Drug Administration
provide this information on the cover
such as medical information, your or sheet and not in the body of your [Docket No. FDA–2016–N–0001]
anyone else’s Social Security number, or comments and you must identify this
confidential business information, such information as ‘‘confidential.’’ Any Circulatory System Devices Panel of
as a manufacturing process. Please note information marked as ‘‘confidential’’ the Medical Devices Advisory
that if you include your name, contact will not be disclosed except in Committee; Notice of Meeting
information, or other information that accordance with 21 CFR 10.20 and other AGENCY: Food and Drug Administration,
identifies you in the body of your applicable disclosure law. For more HHS.
comments, that information will be information about FDA’s posting of ACTION: Notice.
posted on https://www.regulations.gov. comments to public dockets, see 80 FR
• If you want to submit a comment 56469, September 18, 2015, or access SUMMARY: The Food and Drug
with confidential information that you the information at: http://www.fda.gov/ Administration (FDA) announces a
do not wish to be made available to the regulatoryinformation/dockets/ forthcoming public advisory committee
public, submit the comment as a default.htm. meeting of the Circulatory System
written/paper submission and in the Docket: For access to the docket to Devices Panel of the Medical Devices
manner detailed (see ‘‘Written/Paper read background documents or the Advisory Committee. The general
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments function of the committee is to provide
Written Submissions received, go to https:// advice and recommendations to the
www.regulations.gov and insert the Agency on FDA’s regulatory issues. The
Submit written submissions in the meeting will be open to the public.
docket number(s), found in brackets in
following ways:
the heading of this document, into the DATES: The meeting will be held on
• Mail/Hand delivery/Courier (for
‘‘Search’’ box and follow the prompts February 23, 2017, from 8 a.m. to 6 p.m.
written/paper submissions): Division of
and/or go to the Division of Dockets ADDRESSES: Hilton Washington, DC/
Dockets Management (HFA–305), Food
Management, 5630 Fishers Lane, Rm. North, Salons A, B, C and D, 620 Perry
and Drug Administration, 5630 Fishers
1061, Rockville, MD 20852. Pkwy., Gaithersburg, MD 20877. The
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments FOR FURTHER INFORMATION CONTACT: Tara hotel’s phone number is 301–977–8900.
submitted to the Division of Dockets Gooen Bizjak, Center for Drug Answers to commonly asked questions
Management, FDA will post your Evaluation and Research, Food and including information regarding special
comment, as well as any attachments, Drug Administration, 10903 New accommodations due to a disability,
except for information submitted, Hampshire Ave., Bldg. 51, Rm. 2109, visitor parking, and transportation may
marked and identified, as confidential, Silver Spring, MD 20993–0002, 301– be accessed at: http://www.fda.gov/
if submitted as detailed in 796–3257 or Stephen Ripley, Center for AdvisoryCommittees/AboutAdvisory
‘‘Instructions.’’ Biologics Evaluation and Research, Committees/ucm408555.htm.
Instructions: All submissions received Food and Drug Administration, 10903 FOR FURTHER INFORMATION CONTACT:
must include the Docket No. FDA– New Hampshire Ave., Bldg. 71, Rm. Evella Washington, Center for Devices
2015–D–2537 for ‘‘Submission of 7301, Silver Spring, MD 20993–0002, and Radiological Health, Food and Drug
Quality Metrics Data; Revised Draft 240–402–7911. Administration, 10903 New Hampshire
Guidance for Industry.’’ Received SUPPLEMENTARY INFORMATION: In the Ave., Bldg. 66, Rm. G640, Silver Spring,
comments will be placed in the docket Federal Register of November 25, 2016, MD 20993–0002, Evella.Washington@
and, except for those submitted as FDA published a notice of revised draft fda.hhs.gov, 301–796–6683, or FDA
‘‘Confidential Submissions,’’ publicly guidance availability with a 60-day Advisory Committee Information Line,
viewable at https://www.regulations.gov comment period. Comments on the 1–800–741–8138 (301–443–0572 in the
or at the Division of Dockets notice of revised draft guidance Washington, DC area). A notice in the
Federal Register about last minute
sradovich on DSK3GMQ082PROD with NOTICES
Management between 9 a.m. and 4 p.m., availability will inform FDA’s
Monday through Friday. development and proposed modifications that impact a previously
• Confidential Submissions—To implementation of a voluntary phase of announced advisory committee meeting
submit a comment with confidential the quality metrics program. cannot always be published quickly
information that you do not wish to be FDA is extending the comment period enough to provide timely notice.
made publicly available, submit your for an additional 60 days, until March Therefore, you should always check the
comments only as a written/paper 27, 2017. The Agency believes that a 60- Agency’s Web site at http://
submission. You should submit two day extension of the comment period for www.fda.gov/AdvisoryCommittees/
VerDate Sep<11>2014 21:14 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\09JAN1.SGM 09JAN1](https://thefederalregister.org/doc/82_FR_2372/page/2.svg)
Document Created: 2018-10-24 11:09:17
Document Modified: 2018-10-24 11:09:17
| 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 of availability; extension of comment period. | |
| Dates | FDA is extending the comment period on the notice of revised draft guidance availability published on November 25, 2016 (81 FR 85226). Submit either electronic or written comments by March 27, 2017. | |
| Contact | Tara Gooen Bizjak, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2109, Silver Spring, MD 20993-0002, 301- 796-3257 or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 82 FR 2367 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR