60 Day FRN

13656

Federal Register / Vol. 85, No. 46 / Monday, March 9, 2020 / Notices

6,125 hours. There are no other costs to
respondents other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Total burden
(in hours)

Form

Persons Screened ............................
Informed Consent .............................
Eligible Participants ...........................

Eligibility Screening Form ................
Informed Consent Form ...................
IDU Survey .......................................

10,499
9000
9000

1
1
1

5/60
5/60
30/60

875
750
4,500

Total ...........................................

...........................................................

........................

........................

........................

6,125

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–04722 Filed 3–6–20; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–20–20HR; Docket No. CDC–2020–
0019]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).

AGENCY:

ACTION:

Notice with comment period.

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled Community-Based Organizations’
Changes in Preparedness and Resources
for Support of Biomedical HIV
Prevention. The information collection
project will be used to assess
community-based organizations’ (CBOs)
awareness of, intentions to provide, and
provision of Treatment as Prevention
(TasP), non-occupational post-exposure
prophylaxis (nPEP), or pre-exposure
prophylaxis (PrEP) among clinical and
non-clinical CBOs that have received
funding from CDC’s Division of HIV/
AIDS Prevention (DHAP) and those that
applied but did not receive funding.

SUMMARY:

jbell on DSKJLSW7X2PROD with NOTICES

Average
burden per
response
(hours)

Number of
responses per
respondent

Number of
respondents

Respondent

VerDate Sep<11>2014

17:47 Mar 06, 2020

Jkt 250001

CDC must receive written
comments on or before May 8, 2020.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2020–
0019 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS–D74, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7570; Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
DATES:

PO 00000

Frm 00035

Fmt 4703

Sfmt 4703

The OMB is particularly interested in
comments that will help:
1. 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;
2. Evaluate 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. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. 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 submissions
of responses.
5. Assess information collection costs.
Proposed Project
Community-Based Organizations’
Changes in Preparedness and Resources
for Support of Biomedical HIV
Prevention—New—Division of HIV/
AIDS Prevention (DHAP), National
Center for HIV/AIDS, Viral Hepatitis,
STD, and TB Prevention (NCHHSTP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Antiretroviral (ARV) medications can
be effectively used to reduce the number
of new HIV infections. In persons
without HIV infection, ARVs can be
given as either: (1) For 28 days
following a potential HIV exposure
through sexual or injection behaviors as
nPEP or (2) begun before potential
sexual HIV exposures and taken daily
for months to years as PrEP. In persons
with HIV infection, beginning treating
with ARVs early in their infection (e.g.,
with high CD4 cell counts) can greatly
lower their risk of transmitting infection

E:\FR\FM\09MRN1.SGM

09MRN1

13657

Federal Register / Vol. 85, No. 46 / Monday, March 9, 2020 / Notices
to uninfected sexual partners; this is
also called treatment as prevention or
TasP. PrEP is 99% effective at reducing
the risk of HIV through sexual contact
when taken daily. PrEP is also 74%–
84% effective at reducing the risk of
HIV infection through injection drug use
when taken daily. Persons living with
HIV who are taking ARVs as prescribed
as well as achieving viral suppression
effectively have no risk for transmitting
the virus to an HIV-negative partner
through sexual contact. CDC is working
with various jurisdictions with high HIV
prevalence to increase capacity of ARV
provision, build collaborative efforts
between health departments and
community-based organizations, and
engage multi-sector provider systems to
reach individuals with high risk of HIV
infection as part of the End the HIV
Epidemic Initiative. CBOs will play a
crucial role in the End the HIV
Epidemic Initiative. In a previous
survey conducted by CDC’s Division of
HIV/AIDS Prevention, CBOs reported
high awareness of nPEP, PrEP, and
TasP, but their ability to meet client
need was low. Although clinical CBOs
were more prepared to support the
expansion of biomedical HIV prevention
interventions, the likelihood that all
CBOs would incorporate these
interventions if they had additional
resources was somewhat high.
Research is needed to better
understand the capacity of CBOs to
incorporate biomedical HIV prevention

be contacted from a list of CBOs that
completed the 2015 survey. In addition,
CBOs that received DHAP funding
through PS15–1502 and PS17–1704 will
also be contacted to determine their
interest in participating in the data
collection effort and to nominate a staff
member to complete the survey. Each
organization’s representative will
receive an email with a link to the
survey website (created with Survey
Monkey). The email will instruct the
representative on how to complete the
survey. Three email reminders will be
sent to organizations for those that do
not complete the survey. Where
possible, data from the 2015 survey will
be combined with data from the 2020
survey. Analyses will include
completeness (non-response rates per
item) as well as frequency of item
responses for awareness, intentions, and
provision of PrEP, nPEP, and TasP will
be assessed for all respondents
combined. Frequency and differences in
item responses will be analyzed for
relationship to CBO characteristics (e.g.,
clinical CBOs vs non-clinical CBOs).
Frequency and differences in item
responses will be analyzed across
survey years. We will perform
multivariable analysis as needed (to
assess interactions between time and
type of CBO). The total annualized
burden hours is 165 hours. There are no
other costs to respondents other than
their time.

interventions into their existing
infrastructure. It is unclear whether the
provision of and capacity to provide
nPEP, PrEP, and TasP has increased
among CBOs since the original survey
was conducted. Furthermore, it is
unclear whether non-clinical CBOs have
achieved parity in linking clients to
biomedical HIV prevention
interventions with their clinical
counterparts. This new survey will
assess current capacity and provision of
nPEP, PrEP, and TasP among CBOs
providing HIV services to populations
with increased risk for HIV acquisition.
In addition, the results of this survey
will be compared to the results of the
2015 survey to assess differences in
awareness, capacity, and provision of
biomedical HIV prevention
interventions. Respondents will include
organizations engaged in HIV
prevention and outreach. Up to 330
respondents (N=330; 175 funded CBOs
and 155 CBOs that did not receive
funding) will be recruited to complete
the survey. This project will employ a
cross-sectional survey design. All CBOs
within each of the two strata (1. Clinical
and non-clinical CBOs directly funded
by CDC, and 2. Clinical and non-clinical
CBOs that did not receive CDC funding)
will receive phone calls to elicit interest
in participating in the survey and to
receive the contact information of an
organization’s representative to
complete the survey on behalf of the
organization. Potential respondents will

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Total burden
(in hours)

Form name

Community Based Organization .......

Community Based Organization HIV
Prevention Needs Assessment
Survey.

330

1

30/60

165

Total ...........................................

...........................................................

........................

........................

........................

165

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–04721 Filed 3–6–20; 8:45 am]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–0043]

BILLING CODE 4163–18–P

Contact Dermatitis From Topical Drug
Products for Cutaneous Application:
Human Safety Assessment; Draft
Guidance for Industry; Availability
jbell on DSKJLSW7X2PROD with NOTICES

Average
burden per
response
(in hours)

Number of
responses per
respondent

Type of respondents

AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice of availability.

The Food and Drug
Administration (FDA or Agency) is

SUMMARY:

VerDate Sep<11>2014

17:47 Mar 06, 2020

Jkt 250001

PO 00000

Frm 00036

Fmt 4703

Sfmt 4703

announcing the availability of a draft
guidance for industry entitled ‘‘Contact
Dermatitis From Topical Drug Products
for Cutaneous Application: Human
Safety Assessment.’’ This draft guidance
provides recommendations for the
characterization, during product
development, of local safety of topical
drug products regarding the risk for
contact dermatitis. These
recommendations are specifically
directed to development of topical new
drug products intended for cutaneous
application.
Submit either electronic or
written comments on the draft guidance

DATES:

E:\FR\FM\09MRN1.SGM

09MRN1