60 day FRN

Att 2 60 Day FRN.pdf

Community-based Organization Outcome Monitoring Projects for CBO HIV Prevention Services Clients

60 day FRN

OMB: 0920-1172

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asabaliauskas on DSK3SPTVN1PROD with NOTICES

Federal Register / Vol. 81, No. 86 / Wednesday, May 4, 2016 / Notices
nominations for membership on the
BCCEDCAC. The committee provides
advice and guidance to the Secretary,
HHS, and the Director, CDC, regarding
the early detection and control of breast
and cervical cancer. The committee
makes recommendations regarding
national program goals and objectives;
implementation strategies; program
priorities, including surveillance,
epidemiologic investigations, education
and training, information dissemination,
professional interactions and
collaborations, and policy.
Nominations are being sought for
individuals who have expertise and
qualifications necessary to contribute to
the accomplishments of the committee’s
objectives. The Secretary, HHS, acting
through the Director, CDC, shall appoint
to the advisory committee nominees
with expertise in breast cancer, cervical
cancer, medicine, public health,
behavioral science, epidemiology,
radiology, pathology, clinical medical
care, health education, and surveillance.
Two members may be representatives of
the general public with personal
experience in issues related to breast or
cervical cancer early detection and
control. Members may be invited to
serve for up to four years.
The next cycle of selection of
candidates will conclude in the Summer
of 2016, for selection of potential
nominees to replace members whose
terms will end on March 31, 2017.
Selection of members is based on
candidates’ qualifications to contribute
to the accomplishment of BCCEDCAC
objectives. The U.S. Department of
Health and Human Services will give
close attention to equitable geographic
distribution and to minority and female
representation so long as the
effectiveness of the Committee is not
impaired. Appointments shall be made
without discrimination on the basis of
age, race, ethnicity, gender, sexual
orientation, HIV status, disability, and
cultural, religious, or socioeconomic
status. Consideration is given to a broad
representation of geographic areas
within the U.S., with diverse
representation of both genders, ethnic
and racial minorities, and persons with
disabilities. Nominees must be U.S.
citizens, and cannot be full-time
employees of the U.S. Government.
Candidates should submit the
following items:
D Current curriculum vitae or resume,
including complete contact information
(name, affiliation, mailing address,
telephone numbers, fax number, email
address);
D A 150 word biography for the
nominee;

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D At least one letter of
recommendation from a person(s) not
employed by the U.S. Department of
Health and Human Services. Candidates
may submit letter(s) from current HHS
employees if they wish, but at least one
letter must be submitted by a person not
employed by HHS.
Nominations should be submitted
(postmarked or received) by June 24,
2016:
D Electronic submissions: You may
submit nominations, including
attachments, electronically to
[email protected].
D Regular, Express or Overnight Mail:
Written nominations may be submitted
to the following addressee only: Ms.
Jameka Reese Blackmon, MBA, CMP
c/o BCCEDCAC Secretariat, Centers for
Disease Control and Prevention, 3719
North Peachtree Road, Building 100,
Chamblee, Georgia 30341.
Telephone and facsimile submissions
cannot be accepted.
Contact Person for More Information:
Jameka R. Blackmon, MBA, CMP,
Designated Federal Officer, National
Center for Chronic Disease Prevention
and Health Promotion, CDC, 4770
Buford Hwy. NE., Mailstop F76, Atlanta,
Georgia 30341, Telephone (770) 488–
4880; Fax (770) 488–4760; Email:
[email protected].
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and the
Agency for Toxic Substances and
Disease Registry.
Catherine Ramadei,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2016–10421 Filed 5–3–16; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–16–16AHI; Docket No. CDC–2016–
0041]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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26795

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing efforts to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project entitled ‘‘CommunityBased Organization Outcome
Monitoring Projects for CBO HIV
Prevention Services Clients’’.
DATES: Written comments must be
received on or before July 5, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2016–
0041 by any of the following methods:
• Federal eRulemaking Portal:
Regulation.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
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. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
SUMMARY:

Please note: All public comment should be
submitted through the Federal eRulemaking
portal (Regulations.gov) or by U.S. mail to the
address listed above.

To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact the 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
FOR FURTHER INFORMATION CONTACT:

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Federal Register / Vol. 81, No. 86 / Wednesday, May 4, 2016 / Notices

collection before submitting the
collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. 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.

asabaliauskas on DSK3SPTVN1PROD with NOTICES

Proposed Project
‘‘Community-Based Organization
Outcome Monitoring Projects for CBO
HIV Prevention Services Clients’’—
New—National Center for HIV/AIDS,
Viral Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Community-Based Organizations
(CBOs) play an essential role in reaching
persons at high risk of transmitting and
acquiring HIV infection. Through
Cooperative Agreement #CDC–RFA–
PS15–1502 (CBO–HPS), CDC funds 90
CBOs to provide comprehensive HIV
prevention services to HIV-positive
persons and high-risk HIV-negative
persons. However, the CBO–HIV
Prevention Services (HPS) awardees are
not required to monitor or report on
critical outcomes such as whether HIVpositive persons who are linked to HIV
medical care were retained in care or
prescribed ART, and whether high-risk

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HIV-negative persons who were referred
to Pre-Exposure Prophylaxis (PrEP)
initiated its use. Also, CBO–HPS CBOs
are not required to collect and report
data about clients’ perceived barriers to
accessing HIV prevention services.
CBO–OMP will fund a subset of CBO–
HPS awardees to collect and report data
to CDC about the utilization and
outcomes of the HIV prevention and
support services. This will increase
understanding of HIV prevention and
support services received by CBO–HPS
clients, the outcomes of these services,
and successes and challenges related to
service provision and utilization.
The respondent universe will
comprise clients at 15–18 CBOs funded
by CBO–HPS. CBO–OPM is organized in
two categories: Category 1—HIVpositive clients and Category 2—highrisk HIV-negative clients.
This information collection will
evaluate HIV-prevention services over
time through participant interviews,
record/chart review, CBO–HPS staff
interviews, and focus groups.
Participant interviews will include
questions for participants living with
HIV-positive and high-risk HIV-negative
clients at CBOs funded by CBO–HPS
about demographics, HIV-related risk
behaviors, HIV prevention and support
services received, service outcomes, and
experiences with services over time;
staff interviews about strategies for and
barriers to recruiting and engaging
clients in HIV prevention and support
services; and focus groups with clients
who are receiving HIV prevention
services at CBOs.
For Category 1, self-reported client
interview data will be collected at
baseline, 3, 6, 9 and 15 months. For
Category 2, self-reported client level
data will be collected at baseline, 3, 6,
and 9 months. Participants will
complete a 30-minute, staff-facilitated
interview at baseline and 20-minute
staff-facilitated interviews at each
follow-up, to assess the outcomes of
HIV-prevention services they receive.
This project will also collect
information from CBO–HPS Staff. Two
CBO–HPS staff interviews will be
conducted for Category 1 and two staff
interviews will be conducted for
Category 2. All interviews are expected
to last 2.5 hours.
This project will also collect
information from participant focus
groups. Respondents will also complete
a short demographic questionnaire.
Focus groups will occur twice during
the project period and will last
approximately 90 minutes.
All electronic data will be password
protected and accessible only to project
staff and direct supervisors. Data will be

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stored on network drives which are
regularly backed up by staff.
Participation in this project is strictly
voluntary. The consent process will be
implemented according to the local/
state policies of the funded agencies.
Consent forms are provided. The
consent process for CBO–OMP involves
the agency staff providing an overview
of the project that includes a description
of the benefits of as well as the risks and
discomforts to participation as well as
the protections for the respondent’s
privacy. Participants must sign the
consent form prior to enrolling into the
project.
The information collected by each
funded agency may include personally
identifiable information, such as name
and contact information, in order to
provide continuity of service, follow-up
of referrals, schedule follow-up
interviews and other outreach activities.
Personally identifiable information will
be kept in a locked file cabinet and will
be accessible only to appropriate agency
staff. Any individually identifiable
information collected by funded
agencies will not be submitted to CDC.
The category 1 information collection
will occur over 33 months and will
involve up to 15 CBOs. The population
targeted by Category 1 are HIV-positive
clients who are receiving CBO–HPS
services and have been provided a
CBO–HPS referral to HIV medical care.
They will be screened, interviewed and
CBO staff will collect their medical
records related to their HIV-medical
care visits, CD4 count and viral loads,
and prescription to ART.
The Category 2 information collection
will occur over 21 months and involve
up to 3 CBOs who will target high-risk
HIV-negative clients who are receiving
CBO–HPS services. CBOs will screen
225 persons each year. CBO staff will
collect their medical records about
medical care visits, PrEP prescriptions
and information about which CBO–HPS
referrals. Participants will be
administered a baseline interview as
well as interviews at 3 months, 6
months, and 9 months. Each CBO will
also conduct two focus groups over the
project period, one in each year of the
evaluation.
Each of the CBOs funded to
participate in this project will be
required to submit data they’ve
collected each month to CDC, including
the screener, medical records and CBO–
HPS referrals, baseline interview, 3month follow-up interview, 6-month
follow-up interview, 9-month follow-up
interview, focus groups, and staff
interviews, respectively. There is no
cost to respondents other than their
time. Total burden hours are 1,125.

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Federal Register / Vol. 81, No. 86 / Wednesday, May 4, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form name

General public ...................................

General public ...................................
CBO–HPS grantees ..........................

Screener Participant Interview Category 1.
Medical records abstraction Category 1.
CBO–HPS Referrals Category 1 .....
Baseline Interview Category 1 .........
3,6,9, and 15 Month Follow-up
Interview Category 1.
Screener Focus Group Category 1
Focus Group Questionnaire Category 1.
Focus Group Category 1 .................
Staff Interview Category 1 ...............
Data submission Category 1 and 2
Screener Participant Interview Category 2.
Medical records abstraction Category 2.
CBO–HPS Referrals Category 2 .....
Baseline Interview Category 2 .........
3,6, and 9 Month Follow-up Interview Category 2.
Screener Focus group Category 2 ..
Focus Group Questionnaire Category 2.
Focus Group Category 2 .................
Staff Interview Category 2 ...............

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

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

Facility office staff ..............................
CBO–HPS grantees ..........................
General public ...................................
General public ...................................
General public ...................................
General Public ...................................
General public ...................................
CBO–HPS grantees ..........................
CBO–OMP CBOs ..............................
General public ...................................
Facility office staff ..............................
CBO–HPS grantees ..........................
General public ...................................
General public ...................................
General Public ...................................
General Public ...................................

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. 2016–10399 Filed 5–3–16; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Request for Nominations of
Candidates To Serve on the Healthcare
Infection Control Practices Advisory
Committee (HICPAC)

asabaliauskas on DSK3SPTVN1PROD with NOTICES

Number of
respondents

Type of respondent

The Centers for Disease Control and
Prevention (CDC) is soliciting
nominations for possible membership
on the Healthcare Infection Control
Practices Advisory Committee
(HICPAC).
The Committee provides advice and
guidance to the Secretary, Department
of Health and Human Services (HHS);
the Director, Centers for Disease Control
and Prevention (CDC); the Deputy
Director, Office of Infectious Diseases
(OID), CDC; the Director, National
Center for Emerging and Zoonotic

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Total burden
(hours)

175

1

3/60

9

120

3

3/60

18

120
150
120

3
1
4

3/60
40/60
30/60

18
100
240

150
90

1
1

3/60
2/60

8
3

90
30
18
225

1
1
12
1

1.5
2.5
10/60
3/60

135
75
36
12

168

2

3/60

17

168
210
168

2
1
3

3/60
40/60
30/60

17
140
252

30
18

1
1

3/60
2/60

2
1

18
6

1
1

1.5
2.5

27
15

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

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

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

1,125

Infectious Diseases (NCEZID), CDC; and
the Director, Division of Healthcare
Quality Promotion (DHQP), NCEZID,
CDC, regarding the practice of infection
control and strategies for surveillance,
prevention, and control of healthcareassociated infections, antimicrobial
resistance, and related events in settings
where healthcare is provided, including
hospitals, outpatient settings, long-termcare facilities, and home health
agencies.
Nominations are being sought for
individuals who have expertise and
qualifications necessary to contribute to
the accomplishment of HICPAC
objectives.
The Secretary, HHS, acting through
the Director, CDC, shall appoint to the
advisory committee nominees with
expertise to provide advice regarding
the practice of healthcare infection
control, strategies for surveillance and
prevention and control of healthcareassociated infections in United States
healthcare facilities. Consideration is
given to professional training and
background, points of view represented,
and upcoming issues to be addressed by
the committee. Nominees may be
invited to serve for four-year terms. The
next cycle of selection of candidates
will begin in the spring of 2016, for
selection of potential nominees to

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Average
burden
response
(hours)

Number of
responses per
respondent

Sfmt 4703

replace members whose terms will end
on June 30, 2017.
Selection of members is based on
candidates’ qualifications to contribute
to the accomplishment of HICPAC’s
objectives (http://www.cdc.gov/hicpac/
about.html). The U.S. Department of
Health and Human Services will give
close attention to equitable geographic
distribution and to minority and female
representation so long as the
effectiveness of the Committee is not
impaired.
Appointments shall be made without
discrimination on the basis of age, race,
ethnicity, gender, sexual orientation,
HIV status, disability, and cultural,
religious, or socioeconomic status.
Consideration is given to a broad
representation of geographic areas
within the U.S., with diverse
representation of both genders, ethnic
and racial minorities, and persons with
disabilities. Nominees must be U.S.
citizens, and cannot be full-time
employees of the U.S. Government.
Candidates should submit the following
items:
Current curriculum vitae or resume,
including complete contact information
(name, affiliation, mailing address,
telephone numbers, fax number, email
address) ; At least one letter of
recommendation stating the

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