B - 60 day FRN

14446

Federal Register / Vol. 81, No. 52 / Thursday, March 17, 2016 / Notices

[Pub. L. 67–13, 42 Stat. 20 (June 10, 1921).]
James R. Dalkin,
Director, Financial Management and
Assurance.
[FR Doc. 2016–06051 Filed 3–16–16; 8:45 am]
BILLING CODE 1610–02–P

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

asabaliauskas on DSK3SPTVN1PROD with NOTICES

Request for Nominations of
Candidates To Serve on the Advisory
Committee on Breast Cancer in Young
Women (ACBCYW)
The Centers for Disease Control and
Prevention (CDC) is soliciting
nominations for possible membership
on the Advisory Committee on Breast
Cancer in Young Women (ACBCYW).
The Committee provides advice and
guidance to the Secretary, Department
of Human Services (HHS); the Assistant
Secretary for Health; and the Director,
CDC, regarding the formative research,
development, implementation and
evaluation of evidence-based activities
designed to prevent breast cancer
(particularly among those at heightened
risk) and promote the early detection
and support of young women who
develop the disease. The advice
provided by the Committee will assist in
ensuring scientific quality, timeliness,
utility, and dissemination of credible
appropriate messages and resource
materials.
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, disease
prevention, early detection, diagnosis,
public health, social marketing, genetic
screening and counseling, treatment,
rehabilitation, palliative care, and
survivorship in young women, or in
related disciplines with a specific focus
on young women. Members may be
invited to serve for up to four years. The
next cycle of selection of candidates
will begin in the Spring of 2016, for
selection of potential nominees to
replace members whose terms will end
on November 30, 2016
Selection of members is based on
candidates’ qualifications to contribute
to the accomplishment of ACBCYW
objectives http://www.cdc.gov/maso/
FACM/facmACBCYW.htm. The U.S.
Department of Health and Human

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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); A 150 word biography for the
nominee; 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 April 25,
2016.
Electronic submission: You may
submit nominations, including
attachments, electronically to acbcyw@
cdc.gov.
Regular, Express or Overnight Mail:
Written nominations may be submitted
to the following addressee only:
Temeika L. Fairley, Ph.D., c/o ACBCYW
Designated Federal Officer, CDC, 4770
Buford Highway NE., Mailstop F–76,
Atlanta, Georgia 30341.
Telephone and facsimile submissions
cannot be accepted. Nominations may
be submitted by the candidate or by the
person/organization recommending the
candidate.
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
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2016–06025 Filed 3–16–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Healthcare Infection Control Practices
Advisory Committee (HICPAC)
Correction: This notice was published
in the Federal Register on February 25,
2016, Volume 81, Number 37, Page
9477. The meeting time and date should
read as follows:
9:00 a.m.–6:00 p.m., EDT, March 31,
2016
Contact Person for More Information:
Erin Stone, M.S., Division of Healthcare
Quality Promotion, National Center for
Emerging and Zoonotic Infectious
Diseases, CDC, 1600 Clifton Road NE.,
Mailstop A–07, Atlanta, Georgia 30333;
Telephone (404) 639–4045, 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
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2016–06027 Filed 3–16–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–16–0010; Docket No. CDC–2016–
0030]

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

SUMMARY:

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asabaliauskas on DSK3SPTVN1PROD with NOTICES

Federal Register / Vol. 81, No. 52 / Thursday, March 17, 2016 / Notices
comment on the ‘‘Birth Defects Study
To Evaluate Pregnancy exposureS (BD–
STEPS)’’. The purpose of BD–STEPS is
to identify modifiable maternal
exposures in pregnancy that may
increase the risk for having a pregnancy
affected by certain major, structural
birth defects.
DATES: Written comments must be
received on or before May 16, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2016–
0030 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.
FOR FURTHER INFORMATION CONTACT:
Leroy A. Richardson, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570.
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

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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
Birth Defects Study To Evaluate
Pregnancy exposureS (BD–
STEPS)(formerly titled The National
Birth Defects Prevention Study
(NBDPS)), (OMB Control No. 0920–
0010, Expiration 01/31/2017)—
Revision—National Center on Birth
Defects and Developmental Disabilities
(NCBDDD), Centers for Disease Control
and Prevention (CDC)
Background and Brief Description
CDC has been monitoring the
occurrence of serious birth defects and
genetic diseases in Atlanta since 1967
through the Metropolitan Atlanta
Congenital Defects Program (MACDP).
The MACDP is a population-based
surveillance system for birth defects
currently covering three counties in
Metropolitan Atlanta.
Since 1997, CDC has funded casecontrol studies of major birth defects
that utilize existing birth defect
surveillance registries (including
MACDP) to identify cases and study
birth defects causes in participating
states/municipalities across the United
States.
The current study, BD–STEPS, is a
case-control study that is similar to the
previous CDC-funded birth defects casecontrol study, NBDPS, which stopped
interviewing participants in 2013. As
with NBDPS, BD–STEPS’ control group
infants are randomly selected from birth
certificates or birth hospital records;
mothers of case and control group
infants are interviewed using a
computer-assisted telephone interview.
The results from NBDPS have
improved understanding of the causes

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14447

of birth defects. Over 200 articles have
been written in professional journals
using the data from NBDPS, and BD–
STEPS data will soon be added to
NBDPS data for analysis. The current
BD–STEPS revision is an addition to the
study population for two BD–STEPS
Centers. Specifically, in these two
Centers mothers of stillbirths without
major birth defects will be added to the
study population for BD–STEPS and
mothers of all stillbirths (with and
without birth defects) and all controls in
these two Centers will be asked to
participate in a supplemental telephone
interview.
The BD–STEPS interview takes
approximately forty-five minutes to
complete (the burden estimate includes
both the introductory telephone script/
consent and questionnaire). For five
Centers, a maximum of 275 interviews
are planned per year per center, 200
cases and 75 controls; for the two
Centers participating in additional
stillbirth interviews, 495 interviews are
planned per center, 200 cases with birth
defects, 75 controls, and 220 stillbirths
without birth defects. With seven
centers planned, the maximum
interview burden for all centers
combined would be approximately
1,774 hours. Mothers in five of the
seven BD–STEPS Centers will also be
asked to provide consent for the study
to access previously collected infant
bloodspots. It takes approximately 15
minutes to read, sign and return the
informed consent for retrieval of
bloodspots. For approximately one fifth
of participants, some medical records
review will be conducted. The medical
records release form takes participants
approximately 15 minutes to read, sign
and return. In addition, it takes
approximately 30 minutes for each
medical record reviewer to conduct the
review and send the medical record.
The online questionnaire will be offered
to approximately one third of
participants who report certain
occupations during the telephone
interview; these participants will be
asked to complete additional
occupational questions via a Web site
which will take approximately 20
minutes to answer. In addition, in two
Centers, mothers of stillbirths with and
without birth defects and controls will
be asked to participate in a
supplemental telephone interview that
will take approximately 25 minutes to
complete.
Information gathered from both the
interviews and the Deoxyribonucleic
acid specimens has been and will
continue to be used to study
independent genetic and environmental
factors as well as gene-environment

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Federal Register / Vol. 81, No. 52 / Thursday, March 17, 2016 / Notices

interactions for a broad range of
carefully classified birth defects.
This request is submitted to revise the
previously estimated burden details and

to request OMB clearance for three
additional years. The total estimated
annual burden hours are 3,034.

There are no costs to the respondents
other than their time.

ESTIMATES OF ANNUALIZED BURDEN HOURS
Activity

Mothers (interview) ...........................

Telephone consent and BD–STEPS
questionnaire.
Written consent for bloodspot retrieval.
Online Occupational Questionnaire

Mothers (consent for bloodspot retrieval).
Mothers (online occupational questionnaire).
Mothers
(consent
for
medical
records review).
Records reviewers (medical records
review).
Mothers of all AR/MA stillbirths and
controls (supplemental telephone
interview).
Total ...........................................

1

45/60

1,774

1,375

1

15/60

344

790

1

20/60

263

475

1

15/60

119

475

1

30/60

238

supple-

710

1

25/60

296

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

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

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

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

3,034

Written release for medical records
review.
Pulling and sending records ............
Telephone consent and
mental questionnaire.

[FR Doc. 2016–05949 Filed 3–16–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention

asabaliauskas on DSK3SPTVN1PROD with NOTICES

Advisory Committee to the Director
(ACD), Centers for Disease Control and
Prevention (CDC)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting of the
aforementioned committee:
Time and Date: 8:30 a.m.–3:00 p.m.,
EDT, April 21, 2016.
Place: CDC, Building 19, Global
Communications Center, Auditorium
B3, 1600 Clifton Road NE., Atlanta,
Georgia 30329.
Status: Open to the public, limited
only by the space and phone lines
available. The meeting room
accommodates approximately 50
people. Advance registration for inperson participation is required by April
7, 2016. The public is welcome to
participate during the public comment
period, which is tentatively scheduled
from 2:40 p.m. to 2:45 p.m. This
meeting will also be available by

17:03 Mar 16, 2016

Total burden
hours

2,365

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.

VerDate Sep<11>2014

Average
burden per
response
(in hours)

Number of responses per
respondent

Number of
respondents

Respondents

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teleconference. Please dial (877) 930–
8819 and enter code 1579739.
Web links:
Windows Media: http://
wm.onlinevideoservice.com/CDC1.
Flash: http://
www.onlinevideoservice.com/clients/
CDC/?mount=CDC3.
Smart Phone and Mobile Devices:
http://
wowza01.sea.onlinevideoservice.com/
live/CDC3/playlist.m3u8.
If you are unable to connect using the
link, copy and paste the link into your
web browser. For technical support
please call: (404) 639–3737.
Purpose: The Advisory Committee to
the Director, CDC, shall advise the
Secretary, HHS, and the Director, CDC,
on policy and broad strategies that will
enable CDC to fulfill its mission of
protecting health through health
promotion, prevention, and
preparedness. The committee
recommends ways to prioritize CDC’s
activities, improve results, and address
health disparities. It also provides
guidance to help CDC work more
effectively with its various private and
public sector constituents to make
health protection a practical reality.
Matters for Discussion: The Advisory
Committee to the Director will receive
updates from the State, Tribal, Local
and Territorial Subcommittee; the
Health Disparities Subcommittee, the
Ethical Considerations for Public Private
Partnerships Workgroup, the Global
Workgroup, the Internal and External
Laboratory Safety Workgroups, and the
Public Health—Health Care

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Collaboration Workgroup, as well as an
update from the CDC Director.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information:
Carmen Villar, MSW, Designated
Federal Officer, ACD, CDC, 1600 Clifton
Road NE., M/S D–14, Atlanta, Georgia
30329. Telephone (404) 639–7037,
Email: [email protected]. The deadline to
register for in-person attendance at this
meeting is April 7, 2016. To register,
please send an email to [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
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2016–06026 Filed 3–16–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]

Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of Meeting
AGENCY:

Food and Drug Administration,

HHS.

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