81 FR 24108 - Request for Public Comment: 60-Day Information Collection: Indian Self-Determination and Education Assistance Act Contracts

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service

Federal Register Volume 81, Issue 79 (April 25, 2016)

Page Range		24108-24109
FR Document		2016-09501

In compliance the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``Indian Self-Determination and Education Assistance Act Contracts,'' Office of Management and Budget (OMB) Control Number 0917-0037. IHS is requesting OMB to approve an extension for this collection, which expires on July 31, 2016.

Federal Register, Volume 81 Issue 79 (Monday, April 25, 2016)

[Federal Register Volume 81, Number 79 (Monday, April 25, 2016)]
[Notices]
[Pages 24108-24109]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-09501]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Indian Health Service


Request for Public Comment: 60-Day Information Collection: Indian 
Self-Determination and Education Assistance Act Contracts

AGENCY: Indian Health Service, HHS.

ACTION: Notice and request for comments. Request for extension of 
approval.

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

SUMMARY: In compliance the Paperwork Reduction Act of 1995, the Indian 
Health Service (IHS) invites the general public to comment on the 
information collection titled, ``Indian Self-Determination and 
Education Assistance Act Contracts,'' Office of Management and Budget 
(OMB) Control Number 0917-0037. IHS is requesting OMB to approve an 
extension for this collection, which expires on July 31, 2016.

DATES: Comment Due Date: June 24, 2016. Your comments regarding this 
information collection are best assured of having full effect if 
received within 60 days of the date of this publication.

ADDRESSES: Send your written comments, requests for more information on 
the collection, or requests to obtain a copy of the data collection 
instrument and instructions to Mr. Chris Buchanan by one of the 
following methods:
     Mail: Mr. Chris Buchanan, Director, IHS Office of Direct 
Services and Contracting Tribes (ODSCT), Indian Health Service, 5600 
Fishers Lane, Mail Stop O8E17C, Rockville, MD 20857.
     Phone: 301-443-1104.
     Email: [email protected].
     Fax: 301-480-3192.

SUPPLEMENTARY INFORMATION: This previously approved information 
collection project was last published in the Federal Register (78 FR 
32405), as a joint submission with the Bureau of Indian Affairs (BIA), 
under OMB Control Number 1076-0136, on May 30, 2013 and allowed 30 days 
for public comment. No public comment was received in response to the 
notice. On July 31, 2013, the IHS obtained its own OMB Control Number, 
0917-0037, for this information collection and is now publishing a 
separate notice from the BIA in the Federal Register. The purpose of 
this notice is to allow 60 days for public comment. A copy of the 
supporting statement is available at www.regulations.gov (see Docket ID 
IHS-2016-0003).

[[Page 24109]]

I. Abstract

    Representatives of the IHS seek renewal of the approval for 
information collections conducted under 25 CFR part 900, implementing 
the Indian Self-Determination and Education Assistance Act (ISDEAA), as 
amended (25 U.S.C. 450 et seq.), which describes how contracts are 
awarded to Indian Tribes. The rule at 25 CFR part 900 was developed 
through negotiated rulemaking with Tribes in 1996 and governs, among 
other things, what must be included in a Tribe's initial ISDEAA 
contract proposal to IHS. A response is required to obtain and retain a 
benefit.
    The information requirements for this rule represent significant 
differences from other agencies in several respects. Under the Act, the 
Secretary of Health and Human Services is directed to enter into self-
determination contracts with Tribes upon request, unless specific 
declination criteria apply, and, generally, Tribes may renew these 
contracts annually, whereas other agencies provide grants on a 
discretionary or competitive basis. Additionally, IHS awards contracts 
for multiple programs whereas other agencies usually award single 
grants to Tribes.
    The IHS uses the information collected to determine applicant 
eligibility, evaluate applicant capabilities, protect the service 
population, safeguard Federal funds and other resources, and permit the 
Federal agency to administer and evaluate contract programs. Tribal 
governments or Tribal organizations provide the information by 
submitting contract proposals, and related information, to the IHS, as 
required under Public Law 93-638. No third party notification or public 
disclosure burden is associated with this collection.

II. Request for Comments

    The IHS requests your comments on this collection concerning: (a) 
The necessity of this information collection for the proper performance 
of the functions of the agency, including whether the information will 
have practical utility; (b) the accuracy of the agency's estimate of 
the burden (hours and cost) of the collection of information, including 
the validity of the methodology and assumptions used; (c) ways we could 
enhance the quality, utility, and clarity of the information to be 
collected; and (d) ways we could minimize the burden of the collection 
of the information on the respondents.
    Please note that an agency may not conduct or sponsor, and an 
individual need not respond to, a collection of information unless it 
displays a valid OMB Control Number.
    It is our policy to make all comments available to the public for 
review at the location listed in the ADDRESSES section. Before 
including your address, phone number, email address or other personally 
identifiable information in your comment, you should be aware that your 
entire comment--including your personal identifying information--may be 
made publicly available at any time. While you can ask us in your 
comment to withhold your personal identifying information from public 
review, we cannot guarantee that we will be able to do so.

III. Data

    OMB Control Number: 0917-0037.
    Title: Indian Self-Determination and Education Assistance Act 
Contracts, 25 CFR part 900.
    Brief Description of Collection: An Indian Tribe or Tribal 
organization is required to submit this information each time that it 
proposes to contract with the IHS under the ISDEAA. Each response may 
vary in its length. In addition, each subpart of 25 CFR part 900 
concerns different parts of the contracting process. For example, 
subpart C relates to provisions of the contents for the initial 
contract proposal. The respondents do not incur the burden associated 
with subpart C when contracts are renewed. Subpart F describes minimum 
standards for management systems used by Indian Tribes or Tribal 
organizations under these contracts. Subpart G addresses the 
negotiability of all reporting and data requirements in the contracts. 
Responses are required to obtain or retain a benefit.
    Type of Review: Revision of currently approved collection.
    Respondents: Federally recognized Indian Tribes and Tribal 
organizations.
    Number of Respondents: 566.
    Estimated Number of Responses: 1510.
    Estimated Time per Response: Varies from 1 to 1040 hours, with an 
average of 15.968 hours per response.
    Frequency of Response: Each time programs, functions, services or 
activities are contracted from the IHS under the ISDEAA.
    Estimated Total Annual Hour Burden: 24,112.

    Dated: April 18, 2016.
Elizabeth A. Fowler,
Deputy Director For Management Operations, Indian Health Service.
[FR Doc. 2016-09501 Filed 4-22-16; 8:45 am]
 BILLING CODE 4165-16-P

24108 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Notices

chlorthalidone USP tablets, 15 mg, if all failure, hepatic cirrhosis, and DEPARTMENT OF HEALTH AND
other legal and regulatory requirements corticosteroid and estrogen therapy. HUMAN SERVICES
are met. Chlorthalidone has also been found
FOR FURTHER INFORMATION CONTACT: useful in edema due to various forms of Indian Health Service
Christopher Koepke, Center for Drug renal dysfunction such as nephrotic
syndrome, acute glomerulonephritis, Request for Public Comment: 60-Day
Evaluation and Research, Food and
and chronic renal failure. Information Collection: Indian Self-
Drug Administration, 10903 New
THALITONE (chlorthalidone USP) Determination and Education
Hampshire Ave., Bldg. 51, Rm. 6214,
tablets, 15 mg, are currently listed in the Assistance Act Contracts
Silver Spring, MD 20993–0002, 240–
402–3543. ‘‘Discontinued Drug Product List’’
section of the Orange Book. AGENCY: Indian Health Service, HHS.
SUPPLEMENTARY INFORMATION: In 1984,
Clinipace Worldwide submitted a ACTION:Notice and request for
Congress enacted the Drug Price citizen petition dated September 9, 2015 comments. Request for extension of
Competition and Patent Term (Docket No. FDA–2015–P–3299), under approval.
Restoration Act of 1984 (Pub. L. 98–417) 21 CFR 10.30, requesting that the
(the 1984 amendments), which Agency determine whether SUMMARY: In compliance the Paperwork
authorized the approval of duplicate THALITONE (chlorthalidone USP) Reduction Act of 1995, the Indian
versions of drug products under an tablets, 15 mg, were withdrawn from Health Service (IHS) invites the general
ANDA procedure. ANDA applicants sale for reasons of safety or public to comment on the information
must, with certain exceptions, show that effectiveness. collection titled, ‘‘Indian Self-
the drug for which they are seeking After considering the citizen petition Determination and Education
approval contains the same active and reviewing Agency records and Assistance Act Contracts,’’ Office of
ingredient in the same strength and based on the information, FDA has Management and Budget (OMB) Control
dosage form as the ‘‘listed drug,’’ which determined under § 314.161 that Number 0917–0037. IHS is requesting
is a version of the drug that was THALITONE (chlorthalidone USP) OMB to approve an extension for this
previously approved. ANDA applicants tablets, 15 mg, were not withdrawn for collection, which expires on July 31,
do not have to repeat the extensive reasons of safety or effectiveness. The 2016.
clinical testing otherwise necessary to petitioner has identified no data or other
gain approval of a new drug application DATES: Comment Due Date: June 24,
information suggesting that
(NDA). 2016. Your comments regarding this
THALITONE (chlorthalidone USP)
The 1984 amendments include what information collection are best assured
tablets, 15 mg, were withdrawn for
is now section 505(j)(7) of the Federal of having full effect if received within
reasons of safety or effectiveness. We
Food, Drug, and Cosmetic Act (21 U.S.C. 60 days of the date of this publication.
have carefully reviewed our files for
355(j)(7)), which requires FDA to records concerning the withdrawal of ADDRESSES: Send your written
publish a list of all approved drugs. THALITONE (chlorthalidone USP) comments, requests for more
FDA publishes this list as part of the tablets, 15 mg, from sale. We have also information on the collection, or
‘‘Approved Drug Products With independently evaluated relevant requests to obtain a copy of the data
Therapeutic Equivalence Evaluations,’’ literature and data for possible collection instrument and instructions
which is known generally as the postmarketing adverse events. We have to Mr. Chris Buchanan by one of the
‘‘Orange Book.’’ Under FDA regulations, reviewed the available evidence and following methods:
drugs are removed from the list if the determined that this drug product was • Mail: Mr. Chris Buchanan, Director,
Agency withdraws or suspends not withdrawn from sale for reasons of IHS Office of Direct Services and
approval of the drug’s NDA or ANDA safety or effectiveness. Contracting Tribes (ODSCT), Indian
for reasons of safety or effectiveness or Accordingly, the Agency will Health Service, 5600 Fishers Lane, Mail
if FDA determines that the listed drug continue to list THALITONE Stop O8E17C, Rockville, MD 20857.
was withdrawn from sale for reasons of (chlorthalidone USP) tablets, 15 mg, in • Phone: 301–443–1104.
safety or effectiveness (21 CFR 314.162). the ‘‘Discontinued Drug Product List’’ • Email: Chris.Buchanan@ihs.gov.
A person may petition the Agency to section of the Orange Book. The
determine, or the Agency may • Fax: 301–480–3192.
‘‘Discontinued Drug Product List’’
determine on its own initiative, whether delineates, among other items, drug SUPPLEMENTARY INFORMATION: This
a listed drug was withdrawn from sale products that have been discontinued previously approved information
for reasons of safety or effectiveness. from marketing for reasons other than collection project was last published in
This determination may be made at any safety or effectiveness. ANDAs that refer the Federal Register (78 FR 32405), as
time after the drug has been withdrawn to THALITONE (chlorthalidone USP) a joint submission with the Bureau of
from sale, but must be made prior to tablets, 15 mg, may be approved by the Indian Affairs (BIA), under OMB
approving an ANDA that refers to the Agency as long as they meet all other Control Number 1076–0136, on May 30,
listed drug (§ 314.161 (21 CFR 314.161)). legal and regulatory requirements for 2013 and allowed 30 days for public
FDA may not approve an ANDA that the approval of ANDAs. If FDA comment. No public comment was
does not refer to a listed drug. determines that labeling for this drug received in response to the notice. On
THALITONE (chlorthalidone USP) product should be revised to meet July 31, 2013, the IHS obtained its own
tablets, 15 mg, are the subject of NDA OMB Control Number, 0917–0037, for
asabaliauskas on DSK3SPTVN1PROD with NOTICES

current standards, the Agency will
19–574, held by Citron Pharma LLC, advise ANDA applicants to submit such this information collection and is now
and initially approved on December 20, labeling. publishing a separate notice from the
1988. THALITONE is indicated for the BIA in the Federal Register. The
management of hypertension either Dated: April 19, 2016. purpose of this notice is to allow 60
alone or in combination with other Leslie Kux, days for public comment. A copy of the
antihypertensive drugs. Chlorthalidone Associate Commissioner for Policy. supporting statement is available at
is indicated as an adjunctive therapy in [FR Doc. 2016–09450 Filed 4–22–16; 8:45 am] www.regulations.gov (see Docket ID
edema associated with congestive heart BILLING CODE 4164–01–P IHS–2016–0003).

VerDate Sep<11>2014 19:02 Apr 22, 2016 Jkt 238001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\25APN1.SGM 25APN1

Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Notices 24109

I. Abstract information unless it displays a valid DEPARTMENT OF HEALTH AND
Representatives of the IHS seek OMB Control Number. HUMAN SERVICES
renewal of the approval for information It is our policy to make all comments
available to the public for review at the National Institutes of Health
collections conducted under 25 CFR
part 900, implementing the Indian Self- location listed in the ADDRESSES section.
Before including your address, phone Office of the Director, National
Determination and Education Institutes of Health Notice of Meeting
Assistance Act (ISDEAA), as amended number, email address or other
(25 U.S.C. 450 et seq.), which describes personally identifiable information in Pursuant to section 10(a) of the
how contracts are awarded to Indian your comment, you should be aware Federal Advisory Committee Act, as
Tribes. The rule at 25 CFR part 900 was that your entire comment—including amended (5 U.S.C. App.), notice is
developed through negotiated your personal identifying information— hereby given of a meeting of the
rulemaking with Tribes in 1996 and may be made publicly available at any Advisory Committee to the Director,
governs, among other things, what must time. While you can ask us in your National Institutes of Health.
be included in a Tribe’s initial ISDEAA comment to withhold your personal The meeting will be open to the
contract proposal to IHS. A response is identifying information from public public, with attendance limited to space
required to obtain and retain a benefit. review, we cannot guarantee that we available. Individuals who plan to
The information requirements for this will be able to do so. attend and need special assistance, such
rule represent significant differences III. Data as sign language interpretation or other
from other agencies in several respects. reasonable accommodations, should
Under the Act, the Secretary of Health OMB Control Number: 0917–0037.
notify the Contact Person listed below
and Human Services is directed to enter Title: Indian Self-Determination and in advance of the meeting.
into self-determination contracts with Education Assistance Act Contracts, 25
CFR part 900. Name of Committee: Advisory Committee
Tribes upon request, unless specific to the Director, National Institutes of Health.
declination criteria apply, and, Brief Description of Collection: An Date:June 9–10, 2016.
generally, Tribes may renew these Indian Tribe or Tribal organization is Time: June 09, 2016, 9:00 a.m. to 5:00 p.m.
contracts annually, whereas other required to submit this information each Agenda: NIH Director’s Report, ACD
agencies provide grants on a time that it proposes to contract with Working Group reports.
discretionary or competitive basis. the IHS under the ISDEAA. Each Place: National Institutes of Health
Additionally, IHS awards contracts for response may vary in its length. In Building 31, 6th Floor Conference Room 6C6,
multiple programs whereas other addition, each subpart of 25 CFR part 31 Center Drive, Bethesda, MD 20892.
900 concerns different parts of the Time: June 10, 2016, 9:00 a.m. to
agencies usually award single grants to adjournment
Tribes. contracting process. For example,
Agenda: IC Director Report and other
The IHS uses the information subpart C relates to provisions of the business of the committee.
collected to determine applicant contents for the initial contract Place: National Institutes of Health,
eligibility, evaluate applicant proposal. The respondents do not incur Building 31, 6th Floor Conference Room 6C6,
capabilities, protect the service the burden associated with subpart C 31 Center Drive, Bethesda, MD 20892.
population, safeguard Federal funds and when contracts are renewed. Subpart F Contact Person: Gretchen Wood, Staff
other resources, and permit the Federal describes minimum standards for Assistant, National Institutes of Health,
agency to administer and evaluate management systems used by Indian Office of the Director, One Center Drive,
Tribes or Tribal organizations under Building 1, Room 126, Bethesda, MD
contract programs. Tribal governments
these contracts. Subpart G addresses the 20892,301–496–4272, woodgs@od.nih.gov.
or Tribal organizations provide the
negotiability of all reporting and data Any interested person may file written
information by submitting contract
requirements in the contracts. comments with the committee by forwarding
proposals, and related information, to the statement to the Contact Person listed on
the IHS, as required under Public Law Responses are required to obtain or this notice. The statement should include the
93–638. No third party notification or retain a benefit. name, address, telephone number and when
public disclosure burden is associated Type of Review: Revision of currently applicable, the business or professional
with this collection. approved collection. affiliation of the interested person.
Respondents: Federally recognized In the interest of security, NIH has
II. Request for Comments instituted stringent procedures for entrance
Indian Tribes and Tribal organizations.
The IHS requests your comments on Number of Respondents: 566. onto the NIH campus. All visitor vehicles,
this collection concerning: (a) The including taxicabs, hotel, and airport shuttles
Estimated Number of Responses: will be inspected before being allowed on
necessity of this information collection 1510. campus. Visitors will be asked to show one
for the proper performance of the Estimated Time per Response: Varies form of identification (for example, a
functions of the agency, including from 1 to 1040 hours, with an average government-issued photo ID, driver’s license,
whether the information will have of 15.968 hours per response. or passport) and to state the purpose of their
practical utility; (b) the accuracy of the Frequency of Response: Each time visit.
agency’s estimate of the burden (hours programs, functions, services or Information is also available on the
and cost) of the collection of Institute’s/Center’s home page:http://
activities are contracted from the IHS
information, including the validity of acd.od.nih.gov, where an agenda and any
under the ISDEAA. additional information for the meeting will
the methodology and assumptions used;
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Estimated Total Annual Hour Burden: be posted when available.
(c) ways we could enhance the quality, 24,112.
utility, and clarity of the information to (Catalogue of Federal Domestic Assistance
Dated: April 18, 2016. Program Nos. 93.14, Intramural Research
be collected; and (d) ways we could
Elizabeth A. Fowler, Training Award; 93.22, Clinical Research
minimize the burden of the collection of Loan Repayment Program for Individuals
the information on the respondents. Deputy Director For Management Operations,
from Disadvantaged Backgrounds; 93.232,
Please note that an agency may not Indian Health Service.
Loan Repayment Program for Research
conduct or sponsor, and an individual [FR Doc. 2016–09501 Filed 4–22–16; 8:45 am] Generally; 93.39, Academic Research
need not respond to, a collection of BILLING CODE 4165–16–P Enhancement Award; 93.936, NIH Acquired

VerDate Sep<11>2014 19:02 Apr 22, 2016 Jkt 238001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\25APN1.SGM 25APN1

Document Created: 2016-04-23 01:39:21
Document Modified: 2016-04-23 01:39:21

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 and request for comments. Request for extension of approval.
FR Citation		81 FR 24108

81 FR 24108 - Request for Public Comment: 60-Day Information Collection: Indian Self-Determination and Education Assistance Act Contracts

DEPARTMENT OF HEALTH AND HUMAN SERVICESIndian Health Service

Federal Register Volume 81, Issue 79 (April 25, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service