Agency Information Collection Activities; Proposed Collection; Comment Request, 27406-27407 [2013-11092]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES 27406 Federal Register / Vol. 78, No. 91 / Friday, May 10, 2013 / Notices recommendations to the Agency on FDA’s regulatory issues. DATES: Date and Time: The meeting will be held on July 18, 2013, from 8 a.m. to 5 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Yvette Waples, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, Fax: 301–847–8533, email: AADPAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). 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 at http:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On July 18, 2013, the committee will discuss new drug application (NDA) 022225, sugammadex sodium injection, submitted by Organon USA Inc., for the proposed indications of routine reversal of moderate and deep neuromuscular blockade (NMB) induced by rocuronium or vecuronium and immediate reversal of NMB at 3 minutes after administration of rocuronium. 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 http://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the VerDate Mar<15>2010 18:05 May 09, 2013 Jkt 229001 appropriate advisory committee meeting 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 July 3, 2013. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. 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 June 25, 2013. 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 June 26, 2013. 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 Yvette Waples 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 http://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: May 6, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–11133 Filed 5–9–13; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities; Proposed Collection; Comment Request ACTION: Notice. In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443– 1984. HRSA especially requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. SUMMARY: Information Collection Request Title: Develop and Implement UCARE4LIFE Message Library (OMB No. 0915– xxxx)—New Abstract: HRSA HIV/AIDS Bureau (HAB) will develop and implement the UCARE4LIFE message library project aimed at increasing HIV primary care retention rates for racial and ethnic minority youth aged 15 to 24 living with HIV/AIDS. The primary aims are: (1) to develop, test, and maintain a text message library, which addresses topics of HIV disease management, e.g. appointment keeping, retention in care, and medication adherence rates; and (2) to develop, implement, conduct, and evaluate a pilot study of delivering text messages to targeted youth receiving care at Ryan White grantee sites and other clinical sites. HRSA awarded a two-year contract to the Research Triangle Institute (RTI) International to conduct the UCARE4Life project. The UCARE4Life project is supported by the Department of Health and Human E:\FR\FM\10MYN1.SGM 10MYN1 27407 Federal Register / Vol. 78, No. 91 / Friday, May 10, 2013 / Notices Services Secretary’s Minority AIDS Initiative Fund (SMAIF), fiscal year (FY) 2012 and FY2013 and a gift from the M.A.C. AIDS Fund. The first phase of this project will include focus group interviews with the target audience to test the messages (Aim 1). Approximately 128 individuals will be screened to assess focus group eligibility. Four focus groups will be conducted with up to eight participants in each for a total sample size of 32. The second phase of this project involves the evaluation of the pilot study (Aim 2). This will encompass data collection with patients and providers. Patient participants for the pilot study will be recruited from 10 clinical sites, some of which will be Ryan White grantees. Up to 1,000 individuals will be screened to determine eligibility for the pilot study to recruit a sample of 500 participants (50 from each clinical site). Participants will complete a baseline survey, 3-month survey, 6-month survey, and follow-up survey at 9 months. In addition, 10 patient participants from each clinical site will be selected to participate in an in-depth, qualitative telephone interview for a total of 100 interviews. Finally, up to three clinic staff from the 10 participating clinics will take part in indepth, qualitative telephone interviews (N=30). Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information Number of respondents Form name Number of responses per respondent requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. The annual estimate of burden is as follows: Average burden per response (in hours) Total responses Total burden hours Patient focus group screener ............................................... Patient Focus Group Interview ............................................ Patient Pilot Study Screener ................................................ Patient Pilot Study Surveys ................................................. Patient Pilot Study Qualitative Interviews ............................ Clinic Staff Pilot Study Qualitative Interviews ...................... 128 32 1,000 500 100 30 1 1 1 4 1 1 128 32 1,000 2,000 100 30 0.25 2.00 0.25 0.75 1.00 0.75 32 64 250 1,500 100 22.5 Total .............................................................................. 1,790 ........................ 3,290 ........................ 1,968.5 Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 10–29, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Deadline: Comments on this information collection request must be received within 60 days of this notice. ADDRESSES: Dated: May 3, 2013. Bahar Niakan, Director, Division of Policy and Information Coordination. [FR Doc. 2013–11092 Filed 5–9–13; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration mstockstill on DSK4VPTVN1PROD with NOTICES Council on Graduate Medical Education; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting: Name: Council on Graduate Medical Education (COGME). Date and Time: May 30, 2013, 10:00 a.m.– 5:00 p.m. Eastern Time. VerDate Mar<15>2010 18:05 May 09, 2013 Jkt 229001 Place: Webinar format. Status: The meeting will be open to the public. Purpose: The Council on Graduate Medical Education provides advice and recommendations to the Secretary of the Department of Health and Human Services and to Congress on a range of issues including the supply and distribution of physicians in the United States, current and future physician shortages or excesses, issues relating to foreign medical school graduates, the nature and financing of medical education training, and the development of performance measures and longitudinal evaluation of medical education programs. At this meeting, the Council will finalize work on its 21st Report and then begin discussions for its next report. The Council will also discuss recent developments in the physician workforce and in graduate medical education. Agenda: The meeting on Thursday, May 30, 2013, will begin with opening comments from HRSA senior officials. Work on the Council’s 21st report on the restructuring of graduate medical education will finish. The Council will also discuss current issues related to the physician workforce and graduate medical education with the objective of determining a topic for the next report. The Council will plan for its next meeting, which will be face-to-face, for late summer of 2013. An opportunity will be provided for public comment at the end of the meeting. SUPPLEMENTARY INFORMATION: Information on accessing the webinar PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 will be available via the following Web site two days prior the meeting date: http://www.hrsa.gov/ advisorycommittees/bhpradvisory/ cogme/index.html. The audio portion of the meeting will be computer-based; therefore, anyone wishing to make a public comment should use the Question & Answer Pod anytime during the meeting. The questions will be collected and as many addressed as possible during time provided at the end of the meeting. Anyone wishing further information on the webinar aspects of the meeting should contact Iwona Grodecki at 301–443–8379. The agenda for this meeting will be made available to the public two days prior the meeting date at the abovementioned web address. FOR FURTHER INFORMATION CONTACT: Anyone requesting information regarding the COGME should contact Mr. Shane Rogers, Designated Federal Official within the Bureau of Health Professions, Health Resources and Services Administration, in one of following three ways: (1) Send a request to the following address: Shane Rogers, Designated Federal Official, Bureau of Health Professions, Health Resources and Services Administration, Parklawn Building, Room 9A–27, 5600 Fishers Lane, Rockville, Maryland 20857; (2) E:\FR\FM\10MYN1.SGM 10MYN1

Agencies

[Federal Register Volume 78, Number 91 (Friday, May 10, 2013)]
[Notices]
[Pages 27406-27407]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11092]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities; Proposed Collection; 
Comment Request

ACTION: Notice.

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SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (Section 3506(c)(2)(A) of 
Title 44, United States Code, as amended by the Paperwork Reduction Act 
of 1995, Pub. L. 104-13), the Health Resources and Services 
Administration (HRSA) publishes periodic summaries of proposed projects 
being developed for submission to the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act of 1995. To request more 
information on the proposed project or to obtain a copy of the data 
collection plans and draft instruments, email paperwork@hrsa.gov or 
call the HRSA Reports Clearance Officer at (301) 443-1984.
    HRSA especially requests comments on: (1) The necessity and utility 
of the proposed information collection for the proper performance of 
the agency's functions, (2) the accuracy of the estimated burden, (3) 
ways to enhance the quality, utility, and clarity of the information to 
be collected, and (4) the use of automated collection techniques or 
other forms of information technology to minimize the information 
collection burden.

Information Collection Request Title: Develop and Implement UCARE4LIFE 
Message Library (OMB No. 0915-xxxx)--New

    Abstract: HRSA HIV/AIDS Bureau (HAB) will develop and implement the 
UCARE4LIFE message library project aimed at increasing HIV primary care 
retention rates for racial and ethnic minority youth aged 15 to 24 
living with HIV/AIDS. The primary aims are: (1) to develop, test, and 
maintain a text message library, which addresses topics of HIV disease 
management, e.g. appointment keeping, retention in care, and medication 
adherence rates; and (2) to develop, implement, conduct, and evaluate a 
pilot study of delivering text messages to targeted youth receiving 
care at Ryan White grantee sites and other clinical sites. HRSA awarded 
a two-year contract to the Research Triangle Institute (RTI) 
International to conduct the UCARE4Life project. The UCARE4Life project 
is supported by the Department of Health and Human

[[Page 27407]]

Services Secretary's Minority AIDS Initiative Fund (SMAIF), fiscal year 
(FY) 2012 and FY2013 and a gift from the M.A.C. AIDS Fund.
    The first phase of this project will include focus group interviews 
with the target audience to test the messages (Aim 1). Approximately 
128 individuals will be screened to assess focus group eligibility. 
Four focus groups will be conducted with up to eight participants in 
each for a total sample size of 32.
    The second phase of this project involves the evaluation of the 
pilot study (Aim 2). This will encompass data collection with patients 
and providers. Patient participants for the pilot study will be 
recruited from 10 clinical sites, some of which will be Ryan White 
grantees. Up to 1,000 individuals will be screened to determine 
eligibility for the pilot study to recruit a sample of 500 participants 
(50 from each clinical site). Participants will complete a baseline 
survey, 3-month survey, 6-month survey, and follow-up survey at 9 
months. In addition, 10 patient participants from each clinical site 
will be selected to participate in an in-depth, qualitative telephone 
interview for a total of 100 interviews. Finally, up to three clinic 
staff from the 10 participating clinics will take part in in-depth, 
qualitative telephone interviews (N=30).
    Burden Statement: Burden in this context means the time expended by 
persons to generate, maintain, retain, disclose or provide the 
information requested. This includes the time needed to review 
instructions, to develop, acquire, install and utilize technology and 
systems for the purpose of collecting, validating and verifying 
information, processing and maintaining information, and disclosing and 
providing information, to train personnel and to be able to respond to 
a collection of information, to search data sources, to complete and 
review the collection of information, and to transmit or otherwise 
disclose the information. The total annual burden hours estimated for 
this Information Collection Request are summarized in the table below.
    The annual estimate of burden is as follows:

----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Patient focus group screener....             128               1             128            0.25              32
Patient Focus Group Interview...              32               1              32            2.00              64
Patient Pilot Study Screener....           1,000               1           1,000            0.25             250
Patient Pilot Study Surveys.....             500               4           2,000            0.75           1,500
Patient Pilot Study Qualitative              100               1             100            1.00             100
 Interviews.....................
Clinic Staff Pilot Study                      30               1              30            0.75            22.5
 Qualitative Interviews.........
                                 -------------------------------------------------------------------------------
    Total.......................           1,790  ..............           3,290  ..............         1,968.5
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ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA 
Information Collection Clearance Officer, Room 10-29, Parklawn 
Building, 5600 Fishers Lane, Rockville, MD 20857.
    Deadline: Comments on this information collection request must be 
received within 60 days of this notice.

    Dated: May 3, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-11092 Filed 5-9-13; 8:45 am]
BILLING CODE 4165-15-P