80 FR 50291 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 160 (August 19, 2015)

Page Range		50291-50292
FR Document		2015-20478

Federal Register, Volume 80 Issue 160 (Wednesday, August 19, 2015)

[Federal Register Volume 80, Number 160 (Wednesday, August 19, 2015)]
[Notices]
[Pages 50291-50292]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20478]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-15-0696]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility; (b) Evaluate the 
accuracy of the agencies estimate of the burden of the proposed 
collection of information, including the validity of

[[Page 50292]]

the methodology and assumptions used; (c) Enhance the quality, utility, 
and clarity of the information to be collected; (d) Minimize the burden 
of the collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology, e.g., permitting electronic submission of responses; and 
(e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written 
comments should be received within 30 days of this notice.

Proposed Project

    National HIV Prevention Program Monitoring and Evaluation (NHM&E) 
(OMB 0920-0696, Expiration 03/31/2016)--Revision--National Center for 
HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    CDC is requesting a three-year approval for revision to the 
previously approved project.
    The purpose of this revision is to continue collecting standardized 
HIV prevention program evaluation data from health departments and 
community-based organizations (CBOs) who receive federal funds for HIV 
prevention activities. Grantees have the option of key-entering or 
uploading data to a CDC-provided web-based software application 
(EvaluationWeb[supreg]).
    This revision includes changes to the data variables to adjust to 
the different monitoring and evaluation needs of new funding 
announcements without a change in burden. CDC is adjusting the 
variables by deleting some of the client-level variables related to 
determining risk factors during the HIV Testing process and replacing 
these variables with aggregate testing variables that have previously 
been reported by grantees as part of their progress reports. This will 
streamline and simplify data submission for the grantees.
    The other significant change is to add budget allocation data 
variables for CBOs but offset that addition with reductions in client-
level variables and conversion of some variables to aggregate-level 
reporting. There are other minor changes in variables and values to 
adjust to new technologies and interventions and to improve reporting 
related to linkage to care and retention in care for HIV positive 
persons. However, the number of variables deleted approximately equals 
the number of variables added, so the net result is no change in the 
grantee reporting burden.
    The evaluation and reporting process is necessary to ensure that 
CDC receives standardized, accurate, thorough evaluation data from both 
health department and CBO grantees. For these reasons, CDC developed 
standardized NHM&E variables through extensive consultation with 
representatives from health departments, CBOs, and national partners 
(e.g., The National Alliance of State and Territorial AIDS Directors, 
Urban Coalition of HIV/AIDS Prevention Services, and National Minority 
AIDS Council).
    CDC requires CBOs and health departments who receive federal funds 
for HIV prevention to report non-identifying, client-level and 
aggregate-level, standardized evaluation data to: (1) Accurately 
determine the extent to which HIV prevention efforts are carried out, 
what types of agencies are providing services, what resources are 
allocated to those services, to whom services are being provided, and 
how these efforts have contributed to a reduction in HIV transmission; 
(2) improve ease of reporting to better meet these data needs; and (3) 
be accountable to stakeholders by informing them of HIV prevention 
activities and use of funds in HIV prevention nationwide.
    CDC HIV prevention program grantees will collect, enter or upload, 
and report agency-identifying information, budget data, intervention 
information, and client demographics and behavioral risk 
characteristics. Data collection will include searching existing data 
sources, gathering and maintaining data, document compilation, grantee 
training, review of data, and data entry or upload into the web-based 
system.
    There are no additional costs to respondents other than their time. 
As noted above, the number of added variables is approximately equal to 
the number of deleted variables, so there is no change in burden hours 
from the previously approved information collection. The total 
estimated annual burden hours are 206,226.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                       Number of    Average burden
      Type of respondents            Form name         Number of     responses per   per response
                                                      respondents     respondent       (in hrs.)
--------------------------------------------------------------------------------------------------
Health jurisdiction............  Health Department              69               2            1377
                                  Reporting.
Community-based organization...  Community-based               200               2            40.5
                                  organization
                                  Reporting.
----------------------------------------------------------------------------------------------------------------


Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-20478 Filed 8-18-15; 8:45 am]
 BILLING CODE 4163-18-P

Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Notices 50291

The Prevention Training Centers directly or indirectly by the CDC, information to assess the impact of CBA
(PTCs) and CBA providers are funded involved in HIV prevention service services on organizational capacity (e.g.,
by CDC/Division of STD Prevention delivery. application of knowledge and skills,
(DSTDP) and Division of HIV/AIDS CDC is requesting to use two web- potential organization changes as a
Prevention (DHAP) over the five-year based assessments that will be result of CBA services) and to solicit
period to provide capacity-building administered to recipients of CBA information about how the CBA
services that includes information, services: (1) Training Follow-Up program can be improved. These
training, and technical assistance. CBA Instrument and (2) Technical Assistance interviews will be conducted via
services are requested and provided to (TA) Satisfaction Instrument. The first telephone for up to 15 minutes with a
support health departments, quantitative assessment will be subset of up to 40 recipients of CBA
community-based organizations, and disseminated 90 days after a training services.
healthcare organizations in the event to agency staff who participated in The respondents represent an average
implementation, monitoring and a training activity. It takes of the number of health professionals
evaluation of evidence-based HIV approximately 15 minutes to complete. who receive training and technical
prevention interventions and programs; The purpose of this web-based assistance from the CBA and PTC
building organizational infrastructure; assessment is to determine the training grantees. The data collection is
and community mobilization to participants’ satisfaction with the necessary (a) to assess CBA consumers’
decrease stigma and increase HIV trainers, training materials, and the (community-based organizations, health
testing in high risk communities. Under course pace, benefits from the training, departments, and healthcare
this project, there will be no duplication and CBA needs, how relevant the organizations) satisfaction with and
of information collection, because it training was to their work, and whether short-term outcomes from the overall
builds on existing, OMB approved data they were able to utilize the information CBA program as well as specific
collection activities. gained from the training. The second elements of the CBA program; (b) to
The PTCs and CBA providers offer quantitative assessment will be improve CBA services and enhance the
classroom and experiential training, disseminated 45 days after a technical Capacity Building Branch’s national
web-based training, clinical assistance event to agency staff who capacity building strategy over time; (c)
consultation, and capacity building participated in a technical assistance to assess the performance of the grantees
assistance to maintain and enhance the and will take about 15 minutes. The in delivering training and technical
capacity of healthcare professionals to second assessment will measure assistance and to standardize the
control and prevent STDs and HIV. participants’ satisfaction with the registration processes across the two
The CBA service recipients are technical assistance they received, CBA programs (i.e., the PTC program
healthcare professionals such as, intended or actual use of enhanced and the CBA program) and multiple
physicians, nurses, and health capacity, barriers and facilitators to use, grantees funded by each program.
educators, etc., who work at and benefits of the technical assistance. There are no costs to respondents
community-based organizations (CBOs), The purpose of the contractor other than their time. The estimated
health departments, and healthcare administered CBA Key Informant annualized burden hours are 8,643
organizations, most of whom are funded Interview is to collect qualitative hours.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondent Form name responses per
respondents response
respondent (in hours)

Healthcare Professionals .............. Health Professional Application for Training (HPAT) ...... 7,400 2 5/60
Healthcare Professionals .............. Training Follow-up Instrument ......................................... 3,700 2 15/60
Healthcare Professionals .............. Training Telephone Script ................................................ 3,700 2 15/60
Healthcare Professionals .............. Technical Assistance (TA) Satisfaction Instrument ......... 3,700 2 15/60
Healthcare Professionals .............. Technical Assistance Telephone Script ........................... 3,700 2 15/60
Healthcare Professionals .............. CBA Key Informant Interview Script ................................ 40 1 15/60

Leroy A. Richardson, DEPARTMENT OF HEALTH AND the proposed information collection is
Chief, Information Collection Review Office, HUMAN SERVICES published to obtain comments from the
Office of Scientific Integrity, Office of the public and affected agencies.
Associate Director for Science, Office of the Centers for Disease Control and Written comments and suggestions
Director, Centers for Disease Control and Prevention from the public and affected agencies
Prevention. concerning the proposed collection of
[FR Doc. 2015–20477 Filed 8–18–15; 8:45 am] [30Day-15–0696] information are encouraged. Your
BILLING CODE 4163–18–P
Agency Forms Undergoing Paperwork comments should address any of the
Reduction Act Review following: (a) Evaluate whether the
proposed collection of information is
tkelley on DSK3SPTVN1PROD with NOTICES

The Centers for Disease Control and necessary for the proper performance of
Prevention (CDC) has submitted the the functions of the agency, including
following information collection request whether the information will have
to the Office of Management and Budget practical utility; (b) Evaluate the
(OMB) for review and approval in accuracy of the agencies estimate of the
accordance with the Paperwork burden of the proposed collection of
Reduction Act of 1995. The notice for information, including the validity of

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50292 Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Notices

the methodology and assumptions used; community-based organizations (CBOs) health departments, CBOs, and national
(c) Enhance the quality, utility, and who receive federal funds for HIV partners (e.g., The National Alliance of
clarity of the information to be prevention activities. Grantees have the State and Territorial AIDS Directors,
collected; (d) Minimize the burden of option of key-entering or uploading data Urban Coalition of HIV/AIDS
the collection of information on those to a CDC-provided web-based software Prevention Services, and National
who are to respond, including through application (EvaluationWeb®). Minority AIDS Council).
the use of appropriate automated, This revision includes changes to the CDC requires CBOs and health
electronic, mechanical, or other data variables to adjust to the different departments who receive federal funds
technological collection techniques or monitoring and evaluation needs of new for HIV prevention to report non-
other forms of information technology, funding announcements without a identifying, client-level and aggregate-
e.g., permitting electronic submission of change in burden. CDC is adjusting the level, standardized evaluation data to:
responses; and (e) Assess information variables by deleting some of the client- (1) Accurately determine the extent to
collection costs. level variables related to determining which HIV prevention efforts are carried
To request additional information on risk factors during the HIV Testing out, what types of agencies are
the proposed project or to obtain a copy process and replacing these variables providing services, what resources are
of the information collection plan and with aggregate testing variables that allocated to those services, to whom
instruments, call (404) 639–7570 or have previously been reported by services are being provided, and how
send an email to omb@cdc.gov. Written grantees as part of their progress reports. these efforts have contributed to a
comments and/or suggestions regarding This will streamline and simplify data reduction in HIV transmission; (2)
the items contained in this notice submission for the grantees. improve ease of reporting to better meet
should be directed to the Attention: The other significant change is to add these data needs; and (3) be accountable
CDC Desk Officer, Office of Management budget allocation data variables for to stakeholders by informing them of
and Budget, Washington, DC 20503 or CBOs but offset that addition with HIV prevention activities and use of
by fax to (202) 395–5806. Written reductions in client-level variables and funds in HIV prevention nationwide.
comments should be received within 30 conversion of some variables to CDC HIV prevention program grantees
days of this notice. aggregate-level reporting. There are will collect, enter or upload, and report
other minor changes in variables and agency-identifying information, budget
Proposed Project values to adjust to new technologies and data, intervention information, and
National HIV Prevention Program interventions and to improve reporting client demographics and behavioral risk
Monitoring and Evaluation (NHM&E) related to linkage to care and retention characteristics. Data collection will
(OMB 0920–0696, Expiration 03/31/ in care for HIV positive persons. include searching existing data sources,
2016)—Revision—National Center for However, the number of variables gathering and maintaining data,
HIV/AIDS, Viral Hepatitis, STD, and TB deleted approximately equals the document compilation, grantee training,
Prevention (NCHHSTP), Centers for number of variables added, so the net review of data, and data entry or upload
Disease Control and Prevention (CDC). result is no change in the grantee into the web-based system.
reporting burden. There are no additional costs to
Background and Brief Description
The evaluation and reporting process respondents other than their time. As
CDC is requesting a three-year is necessary to ensure that CDC receives noted above, the number of added
approval for revision to the previously standardized, accurate, thorough variables is approximately equal to the
approved project. evaluation data from both health number of deleted variables, so there is
The purpose of this revision is to department and CBO grantees. For these no change in burden hours from the
continue collecting standardized HIV reasons, CDC developed standardized previously approved information
prevention program evaluation data NHM&E variables through extensive collection. The total estimated annual
from health departments and consultation with representatives from burden hours are 206,226.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hrs.)

Health jurisdiction ............................................ Health Department Reporting ........................ 69 2 1377
Community-based organization ...................... Community-based organization Reporting ..... 200 2 40.5

Leroy A. Richardson, DEPARTMENT OF HEALTH AND ACTION: Notice; correction.
Chief, Information Collection Review Office, HUMAN SERVICES
Office of Scientific Integrity, Office of the SUMMARY: The Food and Drug
Associate Director for Science, Office of the Food and Drug Administration Administration (FDA) is correcting a
Director, Centers for Disease Control and notice that appeared in the Federal
Prevention.
[Docket No. FDA–2015–N–2781]
Register of June 9, 2014 (79 FR 32964).
Due to some recent confusion with the
tkelley on DSK3SPTVN1PROD with NOTICES

[FR Doc. 2015–20478 Filed 8–18–15; 8:45 am]
BILLING CODE 4163–18–P Obstetrics and Gynecology Device 2014 docket, this 2014 notice and all
Panel of the Medical Device Advisory materials associated with it are being
Committee; Correction moved to a new docket. This document
announces the new docket number.
AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: Lisa
HHS. Granger, Office of Policy, Planning,

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Document Created: 2015-12-15 11:58:43
Document Modified: 2015-12-15 11:58:43

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
FR Citation		80 FR 50291

80 FR 50291 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 80, Issue 160 (August 19, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention