Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 54659-54660 [2013-21557]

Download as PDF Federal Register / Vol. 78, No. 172 / Thursday, September 5, 2013 / Notices ehiers on DSK2VPTVN1PROD with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Allergenic Products Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on November 5, 2013, from 9 a.m. to approximately 3:30 p.m. and on November 6, 2013, from 8:30 a.m. to approximately 2:45 p.m. Location: FDA, 5630 Fishers Lane, Conference Room 1066, Rockville, MD 20857. For those unable to attend in person, the meeting will also be webcast. The webcast will be available at the following links: November 5, 2013: https://fda. yorkcast.com/webcast/Viewer/?peid= 3074a2c9f7ac478db3303477 ac1c146b1d. November 6, 2013: https://fda. yorkcast.com/webcast/Viewer/ ?peid=2f114f7579ef42e8b4ca4523b 0b26eb51d. Contact Person: Donald Jehn or Joanne Lipkind, Food and Drug Administration, 1401 Rockville Pike (HFM–71), Rockville, MD 20852, 301– 827–0314, Donald.Jehn@fda.hhs.gov or Joanne.Lipkind@fda.hhs.gov, 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 https://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 November 5, 2013, the committee will meet in open session to discuss and make recommendations on the safety and efficacy of Oralair, a Sweet Vernal Grass, Perennial Ryegrass, Timothy Grass, Orchard Grass, and Kentucky Bluegrass Mixed Pollens Allergen Extract tablet for sublingual use, manufactured by Stallergenes. On November 6, 2013, the committee will meet in open session to discuss and make recommendations on the safety and efficacy of Grastek, a Timothy Grass Pollen Allergen Extract tablet for sublingual use, manufactured by Merck. VerDate Mar<15>2010 14:10 Sep 04, 2013 Jkt 229001 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 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 October 29, 2013. Oral presentations from the public will be scheduled between approximately 12 noon and 12:30 p.m. on November 5, 2013, and between approximately 11:10 a.m. and 11:40 a.m. on November 6, 2013. 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 October 21, 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 October 22, 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 Donald Jehn or Joanne Lipkind 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/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 54659 Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: August 29, 2013 Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–21555 Filed 9–4–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this ICR should be received within 30 days of this notice. ADDRESSES: Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to OIRA_ submission@omb.eop.gov or by fax to 202–395–5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: Develop and Implement UCARE4LIFE Message Library OMB No. 0915–xxxx– New. Abstract: This project will develop and implement the UCARE4LIFE message library 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 SUMMARY: E:\FR\FM\05SEN1.SGM 05SEN1 54660 Federal Register / Vol. 78, No. 172 / Thursday, September 5, 2013 / Notices 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. 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 ten 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). Patient participants will complete a baseline survey, 3-month survey, 6month survey, and follow-up survey at 9 months. In addition, ten 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 ten 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 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 ICR are summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Number of respondents Form name Number of responses per respondent 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 1000 500 100 30 1 1 1 4 1 1 128 32 1000 2000 100 30 0.25 2.0 0.25 0.75 1.0 0.75 32 64 250 1500 100 22.5 Total .......................................................................... 1790 ........................ 3290 .......................... 1968.5 Dated: August 28, 2013. Bahar Niakan, Director, Division of Policy and Information Coordination. [FR Doc. 2013–21557 Filed 9–4–13; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities; Proposed Collection; Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ehiers on DSK2VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 14:10 Sep 04, 2013 Jkt 229001 ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this Information Collection Request must be received within 60 days of this notice. 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, Maryland 20857. FOR FURTHER INFORMATION CONTACT: 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 Information Collection Clearance Officer at (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: HRSA Telehealth Outcome Measures. OMB No.: 0915–0311—Extension. Abstract: To help carry out its mission, the Office for the Advancement of Telehealth (OAT) created a set of PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 performance measures that grantees can use to evaluate the effectiveness of their services programs and monitor their progress through the use of performance reporting data. Need and Proposed Use of the Information: As required by the Government Performance and Review Act of 1993 (GPRA), all federal agencies must develop strategic plans describing their overall goal and objectives. The Office for the Advancement of Telehealth (OAT) has worked with its grantees to develop performance measures to be used to evaluate and monitor the progress of the grantees. Grantee goals are to: improve access to needed services; reduce rural practitioner isolation; improve health system productivity and efficiency; and improve patient outcomes. In each of these categories, specific indicators were designed to be reported through a performance monitoring Web site. Likely Respondents: Telehealth Network Grantees. 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 E:\FR\FM\05SEN1.SGM 05SEN1

Agencies

[Federal Register Volume 78, Number 172 (Thursday, September 5, 2013)]
[Notices]
[Pages 54659-54660]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21557]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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

SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health Resources and Services Administration
(HRSA) has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period.

DATES: Comments on this ICR should be received within 30 days of this
notice.

ADDRESSES: Submit your comments, including the Information Collection
Request Title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202-395-5806.

FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email the HRSA Information
Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443-
1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: Develop and Implement
UCARE4LIFE Message Library OMB No. 0915-xxxx-New.
Abstract: This project will develop and implement the UCARE4LIFE
message library 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

[[Page 54660]]

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.
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 ten 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). Patient participants will complete a
baseline survey, 3-month survey, 6-month survey, and follow-up survey
at 9 months. In addition, ten 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 ten 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 ICR are summarized in the table below.

Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
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 2.0 64
Patient Pilot Study Screener... 1000 1 1000 0.25 250
Patient Pilot Study Surveys.... 500 4 2000 0.75 1500
Patient Pilot Study Qualitative 100 1 100 1.0 100
Interviews....................
Clinic Staff Pilot Study 30 1 30 0.75 22.5
Qualitative Interviews........
--------------------------------------------------------------------------------
Total...................... 1790 .............. 3290 .............. 1968.5
----------------------------------------------------------------------------------------------------------------

Dated: August 28, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-21557 Filed 9-4-13; 8:45 am]
BILLING CODE 4165-15-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.