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exemptions (b)(4) and (b)(8) of the
Freedom of Information Act.
Abstract: Section 208.63 of Regulation
H requires state member banks to
establish and maintain the same
procedures. Sections 211.5(m)(1) and
211.24(j)(1) of Regulation K require Edge
and agreement corporations and U.S.
branches, agencies, and other offices of
foreign banks supervised by the Federal
Reserve to establish and maintain
procedures reasonably designed to
ensure and monitor compliance with
the BSA and related regulations. There
are no required reporting forms
associated with this information
collection.
Board of Governors of the Federal Reserve
System, September 10, 2015.
Robert deV. Frierson,
Secretary of the Board.
[FR Doc. 2015–23103 Filed 9–14–15; 8:45 am]
BILLING CODE 6210–01–P

GOVERNMENT PUBLISHING OFFICE
Depository Library Council to the
Director; Meeting
The Depository Library Council (DLC)
to the Director, Government Publishing
Office (GPO) will meet on Monday,
October 19, 2015 through Wednesday,
October 21, 2015 in Arlington, Virginia.
The sessions will take place from 8 a.m.
to 5:30 p.m., Monday and Tuesday and
8 a.m. to 12:30 p.m., on Wednesday.
The meeting will be held at the
Doubletree Hotel, 300 Army Navy Drive,
Arlington, Virginia. The purpose of this
meeting is to discuss the Federal
Depository Library Program. All
sessions are open to the public. The
United States Government Publishing
Office is in compliance with the
requirements of Title III of the
Americans with Disabilities Act and
meets all Fire Safety Act regulations.
Davita Vance-Cooks,
Director, Government Publishing Office.
[FR Doc. 2015–23089 Filed 9–14–15; 8:45 am]

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BILLING CODE 1520–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–15–15BEZ; Docket No. CDC–2015–
0081]

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:

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 newly proposed
information collection request entitled
Improving Fetal Alcohol Spectrum
Disorders Prevention Practice through
Practice and Implementation Centers
and National Partnerships.
DATES: Written comments must be
received on or before November 16,
2015.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0081 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.
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 the Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600

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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 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.
Proposed Project
Improving Fetal Alcohol Spectrum
Disorders Prevention and Practice
through Practice and Implementation
Centers and National Partnerships—
New—National Center on Birth Defects
and Developmental Disabilities

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Federal Register / Vol. 80, No. 178 / Tuesday, September 15, 2015 / Notices
(NCBDDD), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The National Center on Birth Defects
and Developmental Disabilities seeks to
collect training evaluation data from
healthcare practitioners and staff in
health systems where FASD-related
practice and systems changes are
implemented, and grantees of Practice
and Implementation Centers and
national partner organizations related to
prevention, identification, and
treatment of fetal alcohol spectrum
disorders (FASDs).
Prenatal exposure to alcohol is a
leading preventable cause of birth
defects and developmental disabilities.
The term ‘‘fetal alcohol spectrum
disorders’’ describes the full continuum
of effects that can occur in an individual
exposed to alcohol in utero. These
effects include physical, mental,
behavioral, and learning disabilities. All
of these have lifelong implications.
The purpose of this program is to
expand previous efforts from FASD
training programs and shift the
perspective from individual training for
practicing health care professionals to
one that capitalizes on prevention
opportunities and the ability to impact
health care practice at the systems level.
Since 2002, CDC funded FASD
Regional Training Centers (RTCs) to
provide education and training to
healthcare professionals and students
about FASD prevention, identification,
and treatment. In July 2013, CDC
convened an expert review panel to
evaluate the effectiveness of the RTC
program overall and make
recommendations about the program.

The panel highlighted several
accomplishments of the RTCs and
proposed several changes for future
programming: (1) The panel identified a
need for more comprehensive coverage
nationally with discipline-specific
trainings, increased use of technology,
greater collaboration with medical
societies, and stronger linkages with
national partner organizations to
increase the reach of training
opportunities, and (2) The panel
suggested that the training centers focus
on demonstrable practice change and
sustainability and place a stronger
emphasis on primary prevention of
FASDs. In addition, it was
recommended that future initiatives
have stronger evaluation components.
Based on the recommendations of the
expert review panel, CDC is placing
increased focus on prevention,
demonstrating practice change,
achieving national coverage, and
strengthening partnerships between
FASD Practice and Implementation
Centers, or PICs (the newly redesigned
RTCs), and medical societies and
national partner organizations. The
National Organization on Fetal Alcohol
Syndrome (NOFAS) also participates in
this project as a resource to the PICS
and national partners. The PICs and
national partners are asked to closely
collaborate in discipline-specific
workgroups (DSWs) and identify
strategies that will increase the reach of
the program on a national level. While
a major focus of the grantees’ work will
be national, regional approaches will be
used to develop new content and ‘‘test
out’’ feasibility and acceptability of
materials, especially among health care

providers and medical societies. In
addition, CDC is placing a stronger
emphasis on evaluation, with both
individual DSW/NOFAS evaluations
and a cross-site evaluation.
CDC requests OMB approval to collect
program evaluation information from (1)
healthcare practitioners from disciplines
targeted by each DSW, including
training participants, (2) health system
staff, and (3) cooperative agreement
grantees over a three-year period.
• Healthcare practitioners will
complete surveys to provide
information on whether project
trainings impacted their knowledge and
practice behavior regarding FASD
identification, prevention, and
treatment. The information will be used
to improve future trainings and assess
whether knowledge and practice
changes occurred. Some participants
will also complete qualitative key
informant interviews to gain additional
information on practice change.
• Health system employees will be
interviewed as part of high impact
evaluation studies. The high impact
evaluation studies will be focused
assessments of two to three specific
grantee efforts that seem likely to result
in achievement of program objectives.
• Grantees will complete program
evaluation forms to track perceptions of
DSW collaboration and perceptions of
key successes and challenges
encountered by the DSW.
It is estimated that 20,554
respondents will participate in the
evaluation each year, for a total
estimated burden of 4528.0 hours
annually. There are no costs to
respondents other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

DSW/
Organization

Form name

FASD Core Training Participants.
FASD Core Training Participants.
FASD Core Training Participants.
Project Grantee Staff .........

All ......................................

FASD Core Training Survey—Pre-Test.
FASD Core Training Survey—Post-Test.
FASD Core Training Survey—6 Month Follow-Up.
DSW Report .....................

All ......................................

Nurses ...............................

Westat (Cross-Site Evaluator).
Westat (Cross-Site Evaluator).
Westat (Cross-Site Evaluator).
Westat (Cross-Site Evaluator).
Nursing .............................

Nurses ...............................

Nursing .............................

Project Grantee Staff .........
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All ......................................

National Partner Staff ........
Health System Staff ..........

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Number of
respondents

Key Informant Interview—
DSW Project Director.
Key Informant Interview—
National Partner.
Key Informant Interview—
Health System Staff.
Key Informant Interviews
with Champions.
Online Survey with
‘‘Friends’’/Members of
the Network.

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Number of
responses
per
respondent

Average
burden per
response
(in hours)

Total
burden
hours

4,013

1

15/60

1,003

4,013

1

15/60

1,003

4,013

1

20/60

1,338

90

2

10/60

30

6

3

60/60

18

6

3

60/60

18

60

3

30/60

90

14

1

45/60

10

34

2

15/60

17

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ESTIMATED ANNUALIZED BURDEN HOURS—Continued
DSW/
Organization

Form name

Healthcare Organization
Representatives.

Nursing .............................

Nurses and Nursing Students.

Nursing .............................

Physicians and students in
allied health professions.
Students in allied health
professions.

Obstetrics & Gynecology ..

Physicians .........................

Obstetrics & Gynecology ..

Physicians .........................

Obstetrics & Gynecology ..

Physicians .........................

Obstetrics & Gynecology ..

Residency Directors, Training Coordinators, Clinic
Directors.
Residency Directors, Training Coordinators, Clinical
Directors, Physicians.
Physicians .........................

Obstetrics & Gynecology ..

Online Survey with
Healthcare Organization
Representatives.
Brief Online Questionnaire
for Nursing Organization
Memberships.
Avatar Training Satisfaction Survey.
Proficiency Ratings
Scale—Standardized
Patient Version.
Proficiency Ratings
Scale—Provider—Baseline.
Proficiency Rating Scale—
Provider—1 Month Follow-Up.
FASD Training Event
Evaluation.
Pre- Assessment of Training Implementation.

Physicians .........................

Pediatrics ..........................

Physicians .........................

Pediatrics ..........................

Physicians .........................
Physicians .........................

Pediatrics ..........................
Social Work & Family Physicians.

Medical and allied health
professionals.
Medical and allied health
professionals.
General public ...................
TOTAL ........................

Type of respondents

Obstetrics & Gynecology ..

Number of
respondents

Total
burden
hours

67

1

30/60

33

2,934

1

10/60

489

1,200

1

6/60

120

600

1

6/60

60

600

1

6/60

60

600

1

2/60

20

124

1

2/60

4

14

1

30/60

7

Post-Assessment of Training Implementation.

14

1

30/60

7

Pediatrics ..........................

120

1

15/60

30

535

1

4/60

36

535

1

4/60

36

50
62

1
1

15/60
8/60

13
8

National Organization on
Fetal Alcohol Syndrome.
National Organization on
Fetal Alcohol Syndrome.
National Organization on
Fetal Alcohol Syndrome.

FASD Core Training Survey—Pediatrics 3 Month
Follow-Up.
Pediatrics DSW Baseline
Survey.
Pediatrics DSW Year 4
Survey.
FASD Toolkit User Survey
Family Medicine Comprehensive Practice
Evaluation.
NOFAS Webinar Survey—
Post-Test.
NOFAS Webinar Survey—
3 Month Follow-Up.
NOFAS Outcomes Vignette.

400

1

5/60

33

400

1

5/60

33

50

1

10/60

8

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

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

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

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

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

4,524

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0609]

[FR Doc. 2015–23088 Filed 9–14–15; 8:45 am]

Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Drug Supply Chain
Security Act Implementation:
Identification of Suspect Product and
Notification

BILLING CODE 4163–18–P

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Average
burden per
response
(in hours)

Obstetrics & Gynecology ..

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.

AGENCY:

Food and Drug Administration,

HHS.
ACTION:

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The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(the PRA).
DATES: Fax written comments on the
collection of information by October 15,
2015.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
[email protected]. All
comments should be identified with the
SUMMARY:

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