81 FR 65661 - Notice of Tribal Consultation and Urban Confer Sessions on the State of the Great Plains Area Indian Health Service; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service Federal Register Volume 81, Issue 185 (September 23, 2016)
Indian Health Service
Federal Register Volume 81, Issue 185 (September 23, 2016)
| Page Range | 65661-65661 | |
| FR Document | 2016-22922 |
[Federal Register Volume 81, Number 185 (Friday, September 23, 2016)] [Notices] [Page 65661] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22922] ----------------------------------------------------------------------- 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
![Federal Register / Vol. 81, No. 185 / Friday, September 23, 2016 / Notices 65661
regulatoryinformation/dockets/ products to electronically self-identify RegulatoryInformation/Guidances/
default.htm. with FDA and update that information default.htm or http://
Docket: For access to the docket to annually. www.regulations.gov.
read background documents or the Self-identification is required for two Dated: September 19, 2016.
electronic and written/paper comments purposes. First, it is necessary to
Leslie Kux,
received, go to http:// determine the universe of facilities
required to pay user fees. Second, self- Associate Commissioner for Policy.
www.regulations.gov and insert the
identification is a central component of [FR Doc. 2016–22944 Filed 9–22–16; 8:45 am]
docket number, found in brackets in the
heading of this document, into the an effort to promote global supply chain BILLING CODE 4164–01–P
‘‘Search’’ box and follow the prompts transparency. The information provided
and/or go to the Division of Dockets through self-identification enables
Management, 5630 Fishers Lane, Rm. quick, accurate, and reliable DEPARTMENT OF HEALTH AND
1061, Rockville, MD 20852. surveillance of generic drugs and HUMAN SERVICES
Submit written requests for single facilitates inspections and compliance.
Most facilities that self-identify are Indian Health Service
copies of this guidance to the Division
of Drug Information, Center for Drug required to pay an annual facility user Notice of Tribal Consultation and
Evaluation and Research, Food and fee. These include facilities Urban Confer Sessions on the State of
Drug Administration, 10001 New manufacturing, or intending to the Great Plains Area Indian Health
Hampshire Ave., Hillandale Building, manufacture, API of human generic
Service; Extension of Comment Period
4th Floor, Silver Spring, MD 20993– drugs and/or finished dosage form (FDF)
0002. Send one self-addressed adhesive human generic drugs. Other facilities, AGENCY: Indian Health Service, HHS.
label to assist that office in processing sites, and organizations must self- ACTION: Notice; extension of comment
your requests. See the SUPPLEMENTARY identify, but are not required to pay the period.
INFORMATION section for electronic annual facility user fee. These include
facilities that solely manufacture SUMMARY: This document extends the
access to the guidance document.
positron emission tomography drugs, or comment period in the Notice of Tribal
FOR FURTHER INFORMATION CONTACT: Consultation and Urban Confer Sessions
sites and organizations that only
Andrew LeBoeuf, Center for Drug perform testing, repackaging, or on the State of the Great Plains Area
Evaluation and Research, Food and relabeling operations. Please note that Indian Health Service announcement
Drug Administration, 10903 New while re-packagers are not required to that was published in the Federal
Hampshire Ave., Silver Spring, MD pay user fees, packagers are, in most Register on June 3, 2016.
20993, 240–402–0503. cases, FDF manufacturers and subject to DATES: The comment period has been
SUPPLEMENTARY INFORMATION: facility fees. extended to November 30, 2016.
I. Background A separate system for the electronic FOR FURTHER INFORMATION CONTACT:
self-identification of generic industry Roselyn Tso, Acting Director, Office of
FDA is announcing the availability of facilities, sites, and organizations was Direct Service and Contracting Tribes,
a guidance for industry entitled ‘‘Self- established for GDUFA. Entities Indian Health Service, 5600 Fishers
Identification of Generic Drug Facilities, required to register and list (under Lane, Mail Stop 08E17, Rockville, MD
Sites, and Organizations.’’ The guidance section 510 of the Federal Food, Drug, 20857, telephone (301) 443–1104. (This
announced in this notice finalizes the and Cosmetic Act (21 U.S.C. 360) or is not a toll-free number.)
draft guidance of the same name section 351 of the Public Health Service
announced in the Federal Register of Dated: September 16, 2016.
Act (42 U.S.C. 262)), and those required
August 27, 2012 (77 FR 51811). to self-identify under GDUFA, submit Mary Smith,
Compared to the draft guidance, the information separately to the respective Principal Deputy Director, Indian Health
final guidance clarifies various matters, systems. Each system populates its own Service.
including that the self-identification database to meet unique requirements [FR Doc. 2016–22922 Filed 9–22–16; 8:45 am]
requirements have been implemented, and deadlines. The new GDUFA system BILLING CODE 4165–16–P
and simplifies the instructions for uses the same platform and technical
electronic submission of self- standards already familiar to
identification information. FDA manufacturers required to register and DEPARTMENT OF HEALTH AND
received one comment on the draft list. HUMAN SERVICES
guidance, which was considered as the This guidance is being issued
guidance was finalized. National Institutes of Health
consistent with FDA’s good guidance
On July 9, 2012, GDUFA (Pub. L. 112– practices regulation (21 CFR 10.115). National Institute of Allergy and
144, Title III) was signed into law by the The guidance represents the current Infectious Diseases; Notice of Closed
President. GDUFA is designed to speed thinking of FDA on ‘‘Self-Identification Meeting
the delivery of safe and effective generic of Generic Drug Facilities, Sites, and
drugs to the public and reduce costs to Organizations.’’ It does not establish any Pursuant to section 10(d) of the
industry. GDUFA enables FDA to assess rights for any person and is not binding Federal Advisory Committee Act, as
user fees to support critical and on FDA or the public. You can use an amended (5 U.S.C. App.), notice is
measurable enhancements to FDA’s alternative approach if it satisfies the hereby given of the following meeting.
generic drugs program. GDUFA will also The meeting will be closed to the
sradovich on DSK3GMQ082PROD with NOTICES
requirements of the applicable statutes
significantly improve global supply and regulations. public in accordance with the
chain transparency by requiring owners provisions set forth in sections
of facilities producing generic drug II. Electronic Access 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
products, active pharmaceutical Persons with access to the Internet as amended. The grant applications and
ingredients (API), and certain other sites may obtain the guidance at either http:// the discussions could disclose
and organizations that support the www.fda.gov/Drugs/ confidential trade secrets or commercial
manufacture or approval of these GuidanceCompliance property such as patentable material,
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Document Created: 2016-09-23 01:43:50
Document Modified: 2016-09-23 01:43:50
| 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 comment period. | |
| Dates | The comment period has been extended to November 30, 2016. | |
| 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.) | |
| FR Citation | 81 FR 65661 |
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