Notice of Tribal Consultation and Urban Confer Sessions on the State of the Great Plains Area Indian Health Service; Extension of Comment Period, 65661 [2016-22922]
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Federal Register / Vol. 81, No. 185 / Friday, September 23, 2016 / Notices
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, 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.
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, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, 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 guidance document.
FOR FURTHER INFORMATION CONTACT:
Andrew LeBoeuf, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 240–402–0503.
SUPPLEMENTARY INFORMATION:
sradovich on DSK3GMQ082PROD with NOTICES
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘SelfIdentification of Generic Drug Facilities,
Sites, and Organizations.’’ The guidance
announced in this notice finalizes the
draft guidance of the same name
announced in the Federal Register of
August 27, 2012 (77 FR 51811).
Compared to the draft guidance, the
final guidance clarifies various matters,
including that the self-identification
requirements have been implemented,
and simplifies the instructions for
electronic submission of selfidentification information. FDA
received one comment on the draft
guidance, which was considered as the
guidance was finalized.
On July 9, 2012, GDUFA (Pub. L. 112–
144, Title III) was signed into law by the
President. GDUFA is designed to speed
the delivery of safe and effective generic
drugs to the public and reduce costs to
industry. GDUFA enables FDA to assess
user fees to support critical and
measurable enhancements to FDA’s
generic drugs program. GDUFA will also
significantly improve global supply
chain transparency by requiring owners
of facilities producing generic drug
products, active pharmaceutical
ingredients (API), and certain other sites
and organizations that support the
manufacture or approval of these
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products to electronically self-identify
with FDA and update that information
annually.
Self-identification is required for two
purposes. First, it is necessary to
determine the universe of facilities
required to pay user fees. Second, selfidentification is a central component of
an effort to promote global supply chain
transparency. The information provided
through self-identification enables
quick, accurate, and reliable
surveillance of generic drugs and
facilitates inspections and compliance.
Most facilities that self-identify are
required to pay an annual facility user
fee. These include facilities
manufacturing, or intending to
manufacture, API of human generic
drugs and/or finished dosage form (FDF)
human generic drugs. Other facilities,
sites, and organizations must selfidentify, but are not required to pay the
annual facility user fee. These include
facilities that solely manufacture
positron emission tomography drugs, or
sites and organizations that only
perform testing, repackaging, or
relabeling operations. Please note that
while re-packagers are not required to
pay user fees, packagers are, in most
cases, FDF manufacturers and subject to
facility fees.
A separate system for the electronic
self-identification of generic industry
facilities, sites, and organizations was
established for GDUFA. Entities
required to register and list (under
section 510 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360) or
section 351 of the Public Health Service
Act (42 U.S.C. 262)), and those required
to self-identify under GDUFA, submit
information separately to the respective
systems. Each system populates its own
database to meet unique requirements
and deadlines. The new GDUFA system
uses the same platform and technical
standards already familiar to
manufacturers required to register and
list.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Self-Identification
of Generic Drug Facilities, Sites, and
Organizations.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/Drugs/
GuidanceCompliance
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65661
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: September 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–22944 Filed 9–22–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Notice of Tribal Consultation and
Urban Confer Sessions on the State of
the Great Plains Area Indian Health
Service; Extension of Comment Period
Indian Health Service, HHS.
Notice; extension of comment
AGENCY:
ACTION:
period.
This document extends the
comment period in the Notice of Tribal
Consultation and Urban Confer Sessions
on the State of the Great Plains Area
Indian Health Service announcement
that was published in the Federal
Register on June 3, 2016.
DATES: The comment period has been
extended to November 30, 2016.
FOR FURTHER INFORMATION CONTACT:
Roselyn Tso, Acting Director, Office of
Direct Service and Contracting Tribes,
Indian Health Service, 5600 Fishers
Lane, Mail Stop 08E17, Rockville, MD
20857, telephone (301) 443–1104. (This
is not a toll-free number.)
SUMMARY:
Dated: September 16, 2016.
Mary Smith,
Principal Deputy Director, Indian Health
Service.
[FR Doc. 2016–22922 Filed 9–22–16; 8:45 am]
BILLING CODE 4165–16–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
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[Federal Register Volume 81, Number 185 (Friday, September 23, 2016)]
[Notices]
[Page 65661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22922]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
Notice of Tribal Consultation and Urban Confer Sessions on the
State of the Great Plains Area Indian Health Service; Extension of
Comment Period
AGENCY: Indian Health Service, HHS.
ACTION: Notice; extension of comment period.
-----------------------------------------------------------------------
SUMMARY: This document extends the comment period in the Notice of
Tribal Consultation and Urban Confer Sessions on the State of the Great
Plains Area Indian Health Service announcement that was published in
the Federal Register on June 3, 2016.
DATES: The comment period has been extended to November 30, 2016.
FOR FURTHER INFORMATION CONTACT: Roselyn Tso, Acting Director, Office
of Direct Service and Contracting Tribes, Indian Health Service, 5600
Fishers Lane, Mail Stop 08E17, Rockville, MD 20857, telephone (301)
443-1104. (This is not a toll-free number.)
Dated: September 16, 2016.
Mary Smith,
Principal Deputy Director, Indian Health Service.
[FR Doc. 2016-22922 Filed 9-22-16; 8:45 am]
BILLING CODE 4165-16-P
