81 FR 24822 - Agency Information Collection Activities: Proposed Collection: Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 81, Issue 81 (April 27, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 81 (April 27, 2016)
| Page Range | 24822-24824 | |
| FR Document | 2016-09772 |
[Federal Register Volume 81, Number 81 (Wednesday, April 27, 2016)] [Notices] [Pages 24822-24824] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-09772] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: 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 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 no later than June 27, 2016. ADDRESSES: Submit your comments to [email protected] or mail the HRSA Information Collection Clearance Officer, Room 14N39, Parklawn Building, 5600 Fishers Lane, Rockville, MD 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 [email protected] or call the HRSA Information Collection Clearance Officer at (301) 443-1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the [[Page 24823]] information request collection title for reference. Information Collection Request Title: Building Futures: Supporting Youth Living with HIV OMB No. 0915-xxxx New. Abstract: The Ryan White HIV/AIDS Program (RWHAP), administered by the HRSA HIV/AIDS Bureau (HRSA/HAB), provides HIV-related services in the United States for people living with HIV (PLWH) who do not have sufficient health care coverage or financial resources to pay for HIV- related services. Fourteen percent of the approximately 512,000 RWHAP clients in 2014 were young adults between the ages of 13 and 30.\1\ HRSA/HAB has awarded a contract, Building Futures: Supporting Youth Living with HIV, to identify and document best-practices and challenges associated with providing HIV care to youth living with HIV. Information learned from high performing and low performing sites serving young people living with HIV (aged 13-24 years) will help identify effective strategies and barriers for helping this population reach viral suppression. The high performing and low performing sites will be chosen from RWHAP-funded providers based on health outcome data from the 2014 Ryan White HIV/AIDS Services Report. Information gathered at these visits will help inform technical assistance (TA) conducted at low performing sites, as well as additional TA products to be made available to other RWHAP providers to improve health outcomes for young people living with HIV. --------------------------------------------------------------------------- \1\ Health Resources and Services Administration. Ryan White HIV/AIDS Program Annual Client-Level Data Report 2014. http://hab.hrsa.gov/data/servicesdelivered/2014RWHAPDataReport.pdf. Published December 2015. Accessed 1/29/2016. --------------------------------------------------------------------------- Need and Proposed Use of the Information: Youth (defined for the purposes of this project as age 13 through 24) in the United States are disproportionately impacted by HIV. In 2014, 9,731 (22 percent) of the 44,073 new HIV diagnoses in the U.S. were among youth between the ages of 13 and 24, with a large majority (81 percent) of these youth diagnoses among older youth aged 20-24.\2\ Young people living with HIV also experience disparities in outcomes along the HIV care continuum.\3\ Among RWHAP clients in 2014, older youth aged 20-24 had the lowest rates of retention in care and both 15-19 year olds and 20- 24 year olds had notably lower rates of viral load suppression as compared to other age groups. Additionally, certain subpopulations such as young men who have sex with men (MSM) of color, lesbian, gay, bisexual, transgender and questioning youth (LGBTQ), and young women of color bear a disproportionate share of the disease burden and have poorer outcomes in the areas of retention in care and viral suppression.4 5 --------------------------------------------------------------------------- \2\ Centers for Disease Control and Prevention, ``Diagnoses of HIV Infection in the United States and Dependent Areas, 2014,'' HIV Surveillance Supplemental Report; Vol 26, November 2015, http://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-us.pdf. \3\ ``HIV/AIDS Care Continuum,'' accessed January 26, 2016, https://www.aids.gov/federal-resources/policies/care-continuum/. \4\ Centers for Disease Control and Prevention, ``HIV Among Youth,'' HIV Among Youth, June 30, 2015, http://www.cdc.gov/hiv/group/age/youth/index.html. \5\ ``Youth and Young Adults in the Ryan White HIV/AIDS Program,'' September 2015, http://hab.hrsa.gov/data/reports/youthdatareport2015.pdf. --------------------------------------------------------------------------- The Building Futures: Supporting Youth Living with HIV project aims to strengthen RWHAP engagement with young people aged 13-24 living with HIV to improve their health outcomes. Through this project, HRSA/HAB will systematically document strategies used by providers funded by the RWHAP to achieve high rates of youth retention in care and viral suppression. HRSA/HAB will also learn about gaps and challenges from providers that have demonstrated poorer outcomes in these areas. Specialized Site Visits will be conducted with 10 high performing providers to identify, understand, and document replicable evidence- based best practices and models of care. Interviews will be conducted with program support and clinical staff, in addition to HIV-positive youth patients. HIV-positive youth leaders will be engaged as consultants to the site visit team to pretest instruments, review site visit conclusions with the project team, and offer a perspective of young people living with HIV on the data gathered from the high- performing sites and implementation of changes to improve performance of lower performing sites. Performance Improvement Site Visits will be conducted with 16 lower performing providers to better understand the gaps and challenges to providing RWHAP care to youth, share best practices and lessons learned from high performing providers, and provide action-oriented TA to overcome barriers and optimize health outcomes. Youth consultants will co-lead a panel/advisory board of young people living with HIV and a planning session to better understand technical assistance implementation issues. Sampled providers will be selected based on viral load and retention in care rates and the diversity of client populations, as identified in 2014 Ryan White HIV/AIDS Services Report data. Likely Respondents: Clinics funded by the Ryan White HIV/AIDS Program. 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. Total Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of Total burden per Total burden Form name respondents responses per responses response hours respondent (hours) ---------------------------------------------------------------------------------------------------------------- Online Questionnaire............ 26 1 26 0.5 13 Onsite Observational Tool....... 26 1 26 0.5 13 Program Manager and Clinical 20 1 20 1.5 30 Director Interview Guide (High) *.............................. Program Manager and Clinical 32 1 32 1.5 48 Director Interview Guide (Low) **............................. [[Page 24824]] Program and Administrative Staff 50 1 50 1 50 Interview Guide (High) *....... Program and Administrative Staff 80 1 80 1 80 Interview Guide (Low) **....... Youth Focus Group............... 156 1 156 1 156 Youth Interview................. 26 1 26 0.5 13 Panel/advisory board of young 80 1 80 1.5 120 people living with HIV (Low) ** ------------------------------------------------------------------------------- Total....................... 496 .............. 496 .............. 523 ---------------------------------------------------------------------------------------------------------------- * High indicates high performing sites. ** Low indicates low performing sites. HRSA specifically 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. Jackie Painter, Director, Division of Executive Secretariat. [FR Doc. 2016-09772 Filed 4-26-16; 8:45 a.m.] BILLING CODE 4165-15-P
![24822 Federal Register / Vol. 81, No. 81 / Wednesday, April 27, 2016 / Notices
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Total operating
Number of Average
Number of Total annual and
Activity responses per burden per Total hours
respondents responses maintenance
respondent response costs
Request for CLIA Categorization ............. 60 15 900 1 900 $46,800
1 There are no capital costs associated with this collection of information.
The number of respondents is Administration, 10903 New Hampshire Dated: April 19, 2016.
approximately 60. On average, each Avenue, Silver Spring, MD 20993, 301– Sylvia M. Burwell,
respondent will request categorizations 796–3291. Secretary of Health and Human Services.
(independent of a 510(k) or PMA) 15 [FR Doc. 2016–09761 Filed 4–26–16; 8:45 am]
I. Summary
times per year. The cost, not including BILLING CODE P
personnel, is estimated at $52 per hour This organization will expand current
(52 × 900), totaling $46,800. This activities in the Office of Medical Policy
includes the cost of copying and mailing and foster efficient oversight of clinical DEPARTMENT OF HEALTH AND
copies of package inserts and a cover trials conducted through policy HUMAN SERVICES
letter, which includes a statement of the initiatives that build quality upfront and
reason for the request and reference to science-based inspectional approaches. Health Resources and Services
the original 510(k) numbers, including This will provide an oversight and Administration
regulation numbers and product codes. direction for new and ongoing policy
The burden hours are based on FDA initiatives in broad-based medical and Agency Information Collection
familiarity with the types of clinical policy areas, including Activities: Proposed Collection: Public
documentation typically included in a initiatives to improve science and Comment Request
sponsor’s categorization requests, and efficiency trials.
The Food and Drug Administration, AGENCY: Health Resources and Services
costs for basic office supplies (e.g.,
Office of Medical Products and Tobacco, Administration, HHS.
paper).
Center for Drug Evaluation and ACTION: Notice.
Dated: April 21, 2016.
Research, Office of Medical Policy has
Leslie Kux, been restructured as follows: SUMMARY: In compliance with the
Associate Commissioner for Policy. DKKNF. ORGANIZATION. The Office requirement for opportunity for public
[FR Doc. 2016–09769 Filed 4–26–16; 8:45 am] of Medical Policy is headed by the comment on proposed data collection
BILLING CODE 4164–01–P Director, Office of Medical Policy and projects (Section 3506(c)(2)(A) of the
includes the following organizational Paperwork Reduction Act of 1995), the
units: Health Resources and Services
DEPARTMENT OF HEALTH AND Office of Medical Policy Administration (HRSA) announces
HUMAN SERVICES Office of Prescription Drug Promotion plans to submit an Information
Division of Advertising and Promotion Collection Request (ICR), described
Food and Drug Administration Review I below, to the Office of Management and
Division of Advertising and Promotion Budget (OMB). Prior to submitting the
Office of Medical Products and
Review II ICR to OMB, HRSA seeks comments
Tobacco; Center for Drug Evaluation
II. Delegations of Authority from the public regarding the burden
and Research; Statement of
estimate, below, or any other aspect of
Organization, Functions, and Pending further delegation, directives, the ICR.
Delegations of Authority or orders by the Commissioner of Food
DATES: Comments on this Information
AGENCY: Food and Drug Administration, and Drugs, all delegations and
Collection Request must be received no
HHS. redelegations of authority made to
later than June 27, 2016.
ACTION: Notice. officials and employees of affected
organizational components will ADDRESSES: Submit your comments to
SUMMARY: The Food and Drug continue in them or their successors paperwork@hrsa.gov or mail the HRSA
Administration (FDA), Office of Medical pending further redelegations, provided Information Collection Clearance
Products and Tobacco, Center for Drug they are consistent with this Officer, Room 14N39, Parklawn
Evaluation and Research, Office of reorganization. Building, 5600 Fishers Lane, Rockville,
Medical Policy has modified its MD 20857.
III. Electronic Access FOR FURTHER INFORMATION CONTACT: To
structure. This new organizational
structure was approved by the Secretary This reorganization is reflected in request more information on the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
of Health and Human Services on FDA’s Staff Manual Guides (SMG). proposed project or to obtain a copy of
December 15, 2016, and effective on Persons interested in seeing the the data collection plans and draft
April 17, 2016. complete Staff Manual Guide can find it instruments, email paperwork@hrsa.gov
FOR FURTHER INFORMATION CONTACT: on FDA’s Web site at: http:// or call the HRSA Information Collection
Melanie Keller, Office of Management, www.fda.gov/AboutFDA/ Clearance Officer at (301) 443–1984.
Center for Drug Evaluation and ReportsManualsForms/ SUPPLEMENTARY INFORMATION: When
Research, Office of Medical Products StaffManualGuides/default.htm. submitting comments or requesting
and Tobacco, Food and Drug Authority: 44 U.S.C. 3101. information, please include the
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![24824 Federal Register / Vol. 81, No. 81 / Wednesday, April 27, 2016 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (hours)
Program and Administrative Staff Interview Guide (High) * 50 1 50 1 50
Program and Administrative Staff Interview Guide (Low) ** 80 1 80 1 80
Youth Focus Group .............................................................. 156 1 156 1 156
Youth Interview .................................................................... 26 1 26 0.5 13
Panel/advisory board of young people living with HIV
(Low) ** ............................................................................. 80 1 80 1.5 120
Total .............................................................................. 496 ........................ 496 ........................ 523
* High indicates high performing sites.
** Low indicates low performing sites.
HRSA specifically requests comments ADDRESSES: Submit your comments, by each regional center, the number of
on (1) the necessity and utility of the including the Information Collection health care providers receiving
proposed information collection for the Request Title, to the desk officer for professional training or consultation,
proper performance of the agency’s HRSA, either by email to OIRA_ and the time and effort expended on
functions, (2) the accuracy of the submission@omb.eop.gov or by fax to different levels of training and
estimated burden, (3) ways to enhance 202–395–5806. consultation activities. In addition,
the quality, utility, and clarity of the FOR FURTHER INFORMATION CONTACT: To information is obtained on the
information to be collected, and (4) the request a copy of the clearance requests populations served by AETC trainees,
use of automated collection techniques submitted to OMB for review, email the and the increase in capacity achieved
or other forms of information HRSA Information Collection Clearance through training events. Collection of
technology to minimize the information Officer at paperwork@hrsa.gov or call this information allows HRSA to
collection burden. (301) 443–1984. provide information on training
Jackie Painter, SUPPLEMENTARY INFORMATION: activities and types of education and
Director, Division of Executive Secretariat. training provided to Ryan White HIV/
Information Collection Request Title:
[FR Doc. 2016–09772 Filed 4–26–16; 8:45 a.m.] AIDS Program recipients, resource
HRSA AIDS Education and Training
BILLING CODE 4165–15–P Centers Evaluation Activities allocation, and capacity expansion.
Likely Respondents: Trainees are
(OMB No. 0915–0281)—Revision
asked to complete the Participant
DEPARTMENT OF HEALTH AND Abstract: The AIDS Education and Information Form once a year and
HUMAN SERVICES Training Centers (AETC) Program, trainers are asked to complete an Event
under the Title XXVI of the Public Record for each training event they
Health Resources and Services Health Service Act, as amended, conduct during the year. In addition,
Administration supports a network of regional and each regional AETC (8 total) will
national centers that conduct targeted, compile these data into a data set and
Agency Information Collection
multi-disciplinary education and submit to HRSA once a year.
Activities: Submission to OMB for
training programs for health care
Review and Approval; Public Comment Burden Statement: Burden in this
providers treating persons with HIV.
Request context means the time expended by
The AETCs’ purpose is to increase the
AGENCY: Health Resources and Services number of health care providers who are persons to generate, maintain, retain,
Administration, HHS. effectively educated and motivated to disclose or provide the information
ACTION: Notice. counsel, diagnose, treat, and medically requested. This includes the time
manage individuals with HIV infection, needed to review instructions; to
SUMMARY: In compliance with Section and to help prevent high risk behaviors develop, acquire, install and utilize
3507(a)(1)(D) of the Paperwork that lead to HIV transmission. technology and systems for the purpose
Reduction Act of 1995, the Health Need and Proposed Use of the of collecting, validating and verifying
Resources and Services Administration Information: As part of an ongoing effort information, processing and
(HRSA) has submitted an Information to evaluate AETC activities, information maintaining information, and disclosing
Collection Request (ICR) to the Office of is needed on AETC training sessions, and providing information; to train
Management and Budget (OMB) for consultations, and technical assistance personnel and to be able to respond to
review and approval. Comments activities. Each regional center collects a collection of information; to search
submitted during the first public review information on AETC training events, data sources; to complete and review
asabaliauskas on DSK3SPTVN1PROD with NOTICES
of this ICR will be provided to OMB. and is required to report aggregate data the collection of information; and to
OMB will accept further comments from on their activities to HRSA. The data transmit or otherwise disclose the
the public during the review and provides information on the number of information. The total annual burden
approval period. training events, including clinical hours estimated for this Information
DATES: Comments on this ICR must be trainings and consultations, as well as Collection Request are summarized in
received no later than May 27, 2016. technical assistance activities conducted the table below.
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Document Created: 2018-02-07 13:55:27
Document Modified: 2018-02-07 13:55:27
| 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. | |
| Dates | Comments on this Information Collection Request must be received no later than June 27, 2016. | |
| Contact | To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call the HRSA Information Collection Clearance Officer at (301) 443-1984. | |
| FR Citation | 81 FR 24822 |
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