Proposed Collection; Comment Request; The Hispanic Community Health Study (HCHS)/Study of Latinos (SOL), 48872-48873 [2011-20174]

Download as PDF 48872 Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Notices follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On October 14, 2011, the committee will discuss, make recommendations, and vote on a premarket approval application for the Progensa PCA3 assay sponsored by Gen-Probe, Inc. The Progensa PCA3 assay is indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended based on current standard of care, before consideration of PCA3 assay results. A lower PCA3 score is associated with a decreased likelihood of a positive biopsy. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https:// www.fda.gov/AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before September 30, 2011. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m., immediately following lunch. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 22, 2011. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by September 23, 2011. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams at 301–796–5966 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: August 3, 2011. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2011–20118 Filed 8–8–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; The Hispanic Community Health Study (HCHS)/Study of Latinos (SOL) In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National SUMMARY: Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Hispanic Community Health Study (HCHS)/Study of Latinos (SOL). Type of Information Collection Request: Revision of currently approved collection. (OMB# 0925–0584). Need and Use of Information Collection: A baseline examination was conducted from March 3, 2008 to June 30, 2011. HCHS will follow-up new participants enrolled in the past year by telephone for dietary data, and continue to conduct annual follow-up of all participants by telephone to ascertain morbidity and mortality. Physicians/health care providers will be contacted to verify reported events for outcomes ascertainment. The Hispanic Community Health Study (HCHS)/Study of Latinos (SOL) will identify risk factors for cardiovascular and lung disease in Hispanic populations and determine the role of acculturation in the prevalence and development of these diseases. Frequency of Response: The participants will be contacted annually. Affected Public: Individuals or households; Businesses or other for profit; Small businesses or organizations. Type of Respondents: Individuals or households; physicians/ health care providers. The annual reporting burden is as follows: Estimated Number of Respondents: 17,284; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 0.3072; and Estimated Total Annual Burden Hours Requested: 5,309. The annualized cost to respondents is estimated at $104,718, assuming respondents time at the rate of $15 per hour and physician time at the rate of $55 per hour. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. ESTIMATE OF ANNUAL HOUR BURDEN Number of respondents sroberts on DSK5SPTVN1PROD with NOTICES Type of response Frequency of responses Average hours per response Annual hour burden Participant telephone Interviews: a. Follow-up call, Year 1 ........................................................................... b. Follow-up call, Year 2 ........................................................................... c. Follow-up call, Year 3,4,5,6 .................................................................. Non Participant Components: Physician, medical examiner, next of kin or other contact follow-up 1 ..... 1,333 5,333 9,334 1 1 1 0.75 0.25 0.25 1,000 1,333 2,334 1,284 1 0.50 642 Total unique respondents .................................................................. 17,284 ........................ ........................ 5,309 1 Annual burden is placed on doctors 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. VerDate Mar<15>2010 19:06 Aug 08, 2011 Jkt 223001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 E:\FR\FM\09AUN1.SGM 09AUN1 Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Notices Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Larissa AvilesSanta, Project Officer, NIH, NHLBI, 6701 Rockledge Drive, MSC 7936, Bethesda, MD 20892–7936, or call non-toll-free number 301–435–0450 or e-mail your request, including your address to: AvilessantaL@NHLBI.NIH.GOV. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60-days of the date of this publication. DATES: Dated: August 1, 2011. Michael S. Lauer, Director, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, NIH. Lynn Susulske, NHLBI Project Clearance Liaison, National Institutes of Health. [FR Doc. 2011–20174 Filed 8–8–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health sroberts on DSK5SPTVN1PROD with NOTICES National Library of Medicine Notice of Meetings Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of a meeting of the Board of Scientific Counselors, Lister Hill Center for Biomedical Communications. The meeting will be open to the public as indicated below, with attendance limited to space available. VerDate Mar<15>2010 19:06 Aug 08, 2011 Jkt 223001 Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for review, discussion, and evaluation of individual intramural programs and projects conducted by the NATIONAL LIBRARY OF MEDICINE, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Board of Scientific Counselors, Lister Hill Center for Biomedical Communications. Date: September 26–27, 2011. Open: September 26, 2011, 9 a.m. to 11:30 a.m. Agenda: Review of research and development programs and preparation of reports of the Lister Hill Center for Biomedical Communications. Place: National Library of Medicine, Building 38, 2nd Floor, Board Room, 8600 Rockville Pike, Bethesda, MD 20892. Closed: September 26, 2011, 11:30 p.m. to 4:30 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: National Library of Medicine, Building 38, 2nd Floor, Board Room, 8600 Rockville Pike, Bethesda, MD 20892. Open: September 27, 2011, 10 a.m. to 11:15 a.m. Agenda: Review of research and development programs and preparation of reports of the Lister Hill Center for Biomedical Communications. Place: National Library of Medicine, Building 38, 2nd Floor, Board Room, 8600 Rockville Pike, Bethesda, MD 20892. Contact Person: Karen Steely, Program Assistant, Lister Hill Center for Biomedical Communications, National Library of Medicine, Building 38A, Room 7S709, Bethesda, MD 20892, 301–435–3137, ksteely@mail.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 48873 (Catalogue of Federal Domestic Assistance Program No. 93.879, Medical Library Assistance, National Institutes of Health, HHS) Dated: August 3, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2011–20178 Filed 8–8–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging 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 meetings. The meetings 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 would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel, AD Mutation. Date: August 30, 2011. Time: 1 p.m. to 1:45 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Alicja L. Markowska, PhD, DSC, Scientific Review Branch, National Institute On Aging, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301–496–9666, markowsa@nia.nih.gov. Name of Committee: National Institute on Aging Special Emphasis Panel, Registry For AD. Date: August 30, 2011. Time: 1:45 p.m. to 3 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Alicja L. Markowska, PHD, DSC, Scientific Review Branch, National Institute On Aging, 7201 Wisconsin Avenue, Suite 2C212, E:\FR\FM\09AUN1.SGM 09AUN1

Agencies

[Federal Register Volume 76, Number 153 (Tuesday, August 9, 2011)]
[Notices]
[Pages 48872-48873]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20174]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; The Hispanic Community 
Health Study (HCHS)/Study of Latinos (SOL)

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995, for opportunity for public comment 
on proposed data collection projects, the National Heart, Lung, and 
Blood Institute (NHLBI), the National Institutes of Health (NIH) will 
publish periodic summaries of proposed projects to be submitted to the 
Office of Management and Budget (OMB) for review and approval.
    Proposed Collection: Title: Hispanic Community Health Study (HCHS)/
Study of Latinos (SOL). Type of Information Collection Request: 
Revision of currently approved collection. (OMB 0925-0584). 
Need and Use of Information Collection: A baseline examination was 
conducted from March 3, 2008 to June 30, 2011. HCHS will follow-up new 
participants enrolled in the past year by telephone for dietary data, 
and continue to conduct annual follow-up of all participants by 
telephone to ascertain morbidity and mortality. Physicians/health care 
providers will be contacted to verify reported events for outcomes 
ascertainment. The Hispanic Community Health Study (HCHS)/Study of 
Latinos (SOL) will identify risk factors for cardiovascular and lung 
disease in Hispanic populations and determine the role of acculturation 
in the prevalence and development of these diseases. Frequency of 
Response: The participants will be contacted annually. Affected Public: 
Individuals or households; Businesses or other for profit; Small 
businesses or organizations. Type of Respondents: Individuals or 
households; physicians/health care providers. The annual reporting 
burden is as follows: Estimated Number of Respondents: 17,284; 
Estimated Number of Responses per Respondent: 1; Average Burden Hours 
Per Response: 0.3072; and Estimated Total Annual Burden Hours 
Requested: 5,309. The annualized cost to respondents is estimated at 
$104,718, assuming respondents time at the rate of $15 per hour and 
physician time at the rate of $55 per hour. There are no Capital Costs 
to report. There are no Operating or Maintenance Costs to report.

                                         Estimate of Annual Hour Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Frequency of    Average hours    Annual hour
                Type of response                    respondents      responses     per response       burden
----------------------------------------------------------------------------------------------------------------
        Participant telephone Interviews:
    a. Follow-up call, Year 1...................           1,333               1            0.75           1,000
    b. Follow-up call, Year 2...................           5,333               1            0.25           1,333
    c. Follow-up call, Year 3,4,5,6.............           9,334               1            0.25           2,334
           Non Participant Components:
    Physician, medical examiner, next of kin or            1,284               1            0.50             642
     other contact follow-up \1\................
                                                 ---------------------------------------------------------------
        Total unique respondents................          17,284  ..............  ..............           5,309
----------------------------------------------------------------------------------------------------------------
\1\ Annual burden is placed on doctors 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.


[[Page 48873]]

    Request for Comments: Written comments and/or suggestions from the 
public and affected agencies are invited on one or more of the 
following points: (1) Whether the proposed collection of information is 
necessary for the proper performance of the function of the agency, 
including whether the information will have practical utility; (2) The 
accuracy of the agency's estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (3) Ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) Ways to minimize 
the burden of the collection of information on those who are to 
respond, including the use of appropriate automated, electronic, 
mechanical, or other technological collection techniques or other forms 
of information technology.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact Dr. Larissa Aviles-Santa, Project Officer, NIH, 
NHLBI, 6701 Rockledge Drive, MSC 7936, Bethesda, MD 20892-7936, or call 
non-toll-free number 301-435-0450 or e-mail your request, including 
your address to: AvilessantaL@NHLBI.NIH.GOV.

DATES: Comments Due Date: Comments regarding this information 
collection are best assured of having their full effect if received 
within 60-days of the date of this publication.

    Dated: August 1, 2011.
Michael S. Lauer,
Director, Division of Cardiovascular Sciences, National Heart, Lung, 
and Blood Institute, NIH.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2011-20174 Filed 8-8-11; 8:45 am]
BILLING CODE 4140-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.