Submission for OMB Review; 30-Day Comment Request: Women's Health Initiative Observational Study, 32406-32407 [2013-12815]

Download as PDF 32406 Federal Register / Vol. 78, No. 104 / Thursday, May 30, 2013 / Notices TKELLEY on DSK3SPTVN1PROD with NOTICES response time, to: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for IHS. Please send a copy of your comments to Mr. Chris Buchanan, Director, IHS Office of Direct Services and Contracting Tribes (ODSCT), 801 Thompson Ave., STE. 220, Rockville, MD 20852; send via facsimile to (301) 443–4666; or send via email to Chris.Buchanan@ihs.gov. FOR FURTHER INFORMATION CONTACT: Contact Mr. Chris Buchanan through the methods listed in the above section or by calling (301) 443–1104, regarding the IHS information collection activities. You may review the information collection request online at https:// www.reginfo.gov. SUPPLEMENTARY INFORMATION: I. Abstract Representatives of the IHS seek renewal of the approval for information collections conducted under 25 CFR part 900, implementing the Indian SelfDetermination 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 VerDate Mar<15>2010 16:25 May 29, 2013 Jkt 229001 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: 1076–0136. Title: Indian Self-Determination and Education Assistance Contracts, 25 C.F.R. 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. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Type of Review: Extension without change 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 11 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: May 23, 2013. Yvette Roubideaux, Acting Director, Indian Health Services. [FR Doc. 2013–12845 Filed 5–29–13; 8:45 am] BILLING CODE 4165–16–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request: Women’s Health Initiative Observational Study Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), 0020, the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on February 5, 2013 on pages 8152–8153 and allowed 60-days for public comment. One comment was received and an appropriate response was made. The purpose of this notice is to allow an additional 30 days for public comment. The NHLBI, National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments To OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202–395–6974, Attention: NIH Desk Officer. SUMMARY: E:\FR\FM\30MYN1.SGM 30MYN1 32407 Federal Register / Vol. 78, No. 104 / Thursday, May 30, 2013 / Notices Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments, or request more information on the proposed project contact: Shari Eason Ludlam, Project Officer, Women’s Health Initiative Program Office, 6701 Rockledge Drive, 2 Rockledge Centre, Room 9188, MSC 7913, Bethesda, MD 20892–7936, or call (301) 402–2900 or Email your request, including your address to: ludlams@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. DATES: Proposed Collection: Women’s Health Initiative Observational Study. Revision- OMB No. 0925–0414, Expiration Date: 07/31/2013. National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH). Need and Use of Information Collection: This study will be used by the NIH to evaluate risk factors for chronic disease among older women by developing and following a large cohort of postmenopausal women and relating subsequent disease development to baseline assessments of historical, physical, psychosocial, and physiologic characteristics. In addition, the observational study will complement the clinical trial (which has received Number of respondents Type of respondent* OS Participants ................................................................................................ Next of kin ........................................................................................................ Physician/Office Staff ....................................................................................... clinical exemption) and provide additional information on the common causes of frailty, disability and death for postmenopausal women, namely, coronary heart disease, breast and colorectal cancer, and osteoporotic fractures. Continuation of follow-up years for ascertainment of medical history update forms will provide essential data for outcomes assessment for this population of aging women. OMB approval is requested for 3 years. There are no costs to respondents other than their time, which is estimated at $308,218 for all respondents. The total estimated annualized burden hours are 13,927. Number of responses per response 41,495 936 17 1 1 1 Average burden per response (in hours) 20/60 6/60 5/60 Total annual burden hours 13,832 94 1 * Annual burden is placed on health care providers and respondent relatives/informants through requests for information which will help in the compilation of the number and nature of new fatal and nonfatal events. Dated: May 14, 2013. Michael S. Lauer, Director, Division of Cardiovascular Sciences, NHLBI, National Institutes of Health. Lynn W. Susulske, Government Information Specialist, Freedom of Information and Privacy Act Branch, NHLBI, National Institutes of Health. [FR Doc. 2013–12815 Filed 5–29–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health TKELLEY on DSK3SPTVN1PROD with NOTICES Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings 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, and personal information concerning individuals associated with the grant applications, the disclosure of which VerDate Mar<15>2010 16:25 May 29, 2013 Jkt 229001 would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel; ZHD1 DSR–L (SR). Date: June 7, 2013. Time: 4:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6100 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Dennis E. Leszczynski, Ph.D., Scientific Review Officer, Division of Scientific Review, National Institute of Child Health and Human Development, NIH, 6100 Executive Blvd., Room 5B01, Bethesda, MD 20892, 301–435–2717, leszcyd@mail.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: National Institute of Child Health and Human Development Initial Review Group; Reproduction, Andrology, and Gynecology Subcommittee. Date: June 28, 2013. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: Dennis E. Leszczynski, Ph.D., Scientific Review Officer, Division of Scientific Review, National Institute of Child Health and Human Development, NIH, 6100 Executive Blvd., Room 5B01, Bethesda, MD 20892, 301–435–2717, leszcyd@mail.nih.gov. Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel; ZHD1 DSR–Z (KH). PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 Date: July 10, 2013. Time: 2:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6100 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Peter Zelazowski, Ph.D., Scientific Review Officer, Division of Scientific Review, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6100 Executive Blvd., Room 5B01, Bethesda, MD 20892, 301–435–6902, peter.zelazowski@nih.gov. Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel. Date: July 16, 2013. Time: 2:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6100 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Peter Zelazowski, Ph.D., Scientific Review Officer, Division of Scientific Review, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6100 Executive Blvd., Room 5B01, Bethesda, MD 20892, 301–435–6902, peter.zelazowski@nih.gov. Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel. Date: July 30–31, 2013. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, Washington, DC 20015. Contact Person: Cathy J. Wedeen, Ph.D., Scientific Review Officer, Division of E:\FR\FM\30MYN1.SGM 30MYN1

Agencies

[Federal Register Volume 78, Number 104 (Thursday, May 30, 2013)]
[Notices]
[Pages 32406-32407]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12815]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Submission for OMB Review; 30-Day Comment Request: Women's Health
Initiative Observational Study

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Heart, Lung, and Blood Institute
(NHLBI), 0020, the National Institutes of Health, has submitted to the
Office of Management and Budget (OMB) a request for review and approval
of the information collection listed below. This proposed information
collection was previously published in the Federal Register on February
5, 2013 on pages 8152-8153 and allowed 60-days for public comment. One
comment was received and an appropriate response was made. The purpose
of this notice is to allow an additional 30 days for public comment.
The NHLBI, National Institutes of Health, may not conduct or sponsor,
and the respondent is not required to respond to, an information
collection that has been extended, revised, or implemented on or after
October 1, 1995, unless it displays a currently valid OMB control
number.
Direct Comments To OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: NIH Desk Officer.

[[Page 32407]]

DATES: Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, or request more information on the
proposed project contact: Shari Eason Ludlam, Project Officer, Women's
Health Initiative Program Office, 6701 Rockledge Drive, 2 Rockledge
Centre, Room 9188, MSC 7913, Bethesda, MD 20892-7936, or call (301)
402-2900 or Email your request, including your address to:
ludlams@mail.nih.gov. Formal requests for additional plans and
instruments must be requested in writing.
Proposed Collection: Women's Health Initiative Observational Study.
Revision- OMB No. 0925-0414, Expiration Date: 07/31/2013. National
Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health
(NIH).
Need and Use of Information Collection: This study will be used by
the NIH to evaluate risk factors for chronic disease among older women
by developing and following a large cohort of postmenopausal women and
relating subsequent disease development to baseline assessments of
historical, physical, psychosocial, and physiologic characteristics. In
addition, the observational study will complement the clinical trial
(which has received clinical exemption) and provide additional
information on the common causes of frailty, disability and death for
postmenopausal women, namely, coronary heart disease, breast and
colorectal cancer, and osteoporotic fractures. Continuation of follow-
up years for ascertainment of medical history update forms will provide
essential data for outcomes assessment for this population of aging
women.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time, which is estimated at $308,218 for
all respondents. The total estimated annualized burden hours are
13,927.

----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent* Number of responses per per response Total annual
respondents response (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
OS Participants................................. 41,495 1 20/60 13,832
Next of kin..................................... 936 1 6/60 94
Physician/Office Staff.......................... 17 1 5/60 1
----------------------------------------------------------------------------------------------------------------
* Annual burden is placed on health care providers and respondent relatives/informants through requests for
information which will help in the compilation of the number and nature of new fatal and nonfatal events.

Dated: May 14, 2013.
Michael S. Lauer,
Director, Division of Cardiovascular Sciences, NHLBI, National
Institutes of Health.
Lynn W. Susulske,
Government Information Specialist, Freedom of Information and Privacy
Act Branch, NHLBI, National Institutes of Health.
[FR Doc. 2013-12815 Filed 5-29-13; 8:45 am]
BILLING CODE 4140-01-P

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