Request for Nominations From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Blood Products Advisory Committee, 3923-3924 [2020-01057]
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3923
Federal Register / Vol. 85, No. 15 / Thursday, January 23, 2020 / Notices
Comments due within 60 days of
publication. In compliance with the
requirements of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
the Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by emailing
OPREinfocollection@acf.hhs.gov.
Alternatively, copies can also be
obtained by writing to the
Administration for Children and
Families, Office of Planning, Research,
and Evaluation (OPRE), 330 C Street
SW, Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. All requests,
emailed or written should be identified
by the title of the information collection.
DATES:
SUPPLEMENTARY INFORMATION:
Description: The ACF Office of
Planning, Research, and Evaluation is
proposing a new information collection
to learn more about how MIECHVfunded LIAs recruit families for home
visiting services. Data collection will
take place in two phases: (1) Eligibility
assessment and preliminary data
collection and (2) primary data
collection. The first phase, for MIECHVfunded LIAs, includes completion of an
eligibility assessment form, providing
information about community referral
partners, and submitting program
outreach and recruitment materials. The
second phase includes participation, for
LIAs and identified community referral
partners, in a 75-minute semi-structured
interview. For a subset of LIAs, it also
includes submitting management
information system (MIS) data. This
descriptive work will capture how LIAs
and their community referral partners
identify families, refer families to home
visiting services, and enroll and serve
families. The activities and products
from this project will help ACF and the
Health Resources and Services
Administration to identify actionable
bottlenecks in the recruitment and
enrollment process to allow for the
development and testing of strategies to
improve the delivery of MIECHVfunded services.
Respondents: MIECHV-funded LIA
administrators, program managers, and
frontline staff; LIAs participating in the
Home Visiting Applied Research
Collaborative’s (HARC) Practice-Based
Research Network; and LIA community
referral partners.
ANNUAL BURDEN ESTIMATES
Total/annual
number of
respondents
Instrument
LIA Eligibility Assessment Form ......................................................................
LIA Eligibility Assessment Form for MIS Data ................................................
Request for LIA Recommendations from HARC State Networks ...................
Request to LIAs for Community Referral Partner Contact Information ...........
Interview Protocol Local Implementing Agency ...............................................
Interview Protocol Community Referral Partner ..............................................
MIS Data Submission ......................................................................................
jbell on DSKJLSW7X2PROD with NOTICES
Estimated Total Annual Burden
Hours: 425 hours.
Comments: The Department
specifically requests comments 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) the quality, utility,
and clarity of the information to be
collected; and (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. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: Social Security Act Title V
§ 511 [42 U.S.C. 711]. As extended by the
Bipartisan Budget Act of 2018 (Pub. L. 115–
123) through FY22.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–01018 Filed 1–22–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0008]
Request for Nominations From
Industry Organizations Interested in
Participating in the Selection Process
for Nonvoting Industry
Representatives and Request for
Nominations for Nonvoting Industry
Representatives on the Blood
Products Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
requesting that any industry
organizations interested in participating
in the selection of a nonvoting industry
representative to serve on the Blood
Products Advisory Committee (BPAC)
for the Center for Biologics Evaluation
and Research notify FDA in writing.
FDA is also requesting nominations for
a nonvoting industry representative(s) to
serve on the BPAC. A nominee may
either be self-nominated or nominated
SUMMARY:
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
1
1
1
1
1
Average
burden hours
per response
.25
.25
.25
.25
1.25
1.25
8
Annual burden
hours
40
4
6
9
50
188
128
by an organization to serve as a
nonvoting industry representative.
Nominations will be accepted for future
vacancies effective October 1, 2020,
with this notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA by February 24, 2020 (see sections
I and II of this document for further
details). Concurrently, nomination
materials for prospective candidates
should be sent to FDA by February 24,
2020.
ADDRESSES: All statements of interest
from industry organizations interested
in participating in the selection process
of nonvoting industry representative
nominations should be sent via email to
Christina Vert (see FOR FURTHER
INFORMATION CONTACT). All nominations
for nonvoting industry representatives
must be submitted electronically by
accessing the FDA Advisory Committee
Membership Nomination Portal at:
https://www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm.
Information about becoming a member
of an FDA advisory committee can also
E:\FR\FM\23JAN1.SGM
23JAN1
3924
Federal Register / Vol. 85, No. 15 / Thursday, January 23, 2020 / Notices
be obtained by visiting FDA’s website
at: https://www.fda.gov/
AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT:
Christina Vert, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6268,
Silver Spring, MD 20993–0002, 240–
402–8054, Fax: 301–595–1309, email:
Christina.Vert@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency intends to add a nonvoting
industry representative(s) to the
following advisory committee:
jbell on DSKJLSW7X2PROD with NOTICES
I. Blood Products Advisory Committee
BPAC reviews and evaluates available
data concerning the safety,
effectiveness, and appropriate use of
blood, products derived from blood and
serum or biotechnology which are
intended for use in the diagnosis,
prevention, or treatment of human
diseases, and, as required, any other
product for which FDA has regulatory
responsibility, and advises the
Commissioner of Food and Drugs (the
Commissioner) of its findings regarding
screening and testing (to determine
eligibility) of donors and labeling of the
products, on clinical and laboratory
studies involving such products, on the
affirmation or revocation of biological
products licenses, and on the quality
and relevance of FDA’s research
program which provides the scientific
support for regulating these agents.
BPAC will function at times as a
medical device panel under the Federal
Food, Drug, and Cosmetic Act Medical
Device Amendments of 1976. As such,
BPAC recommends classification of
devices subject to its review into
regulatory categories; recommends the
assignment of a priority for the
application of regulatory requirements
for devices classified in the standards or
premarket approval category; advises on
formulation of product development
protocols and reviews premarket
approval applications for those devices
to recommend changes in classification
as appropriate; recommends exemption
of certain devices from the application
of portions of the Federal Food, Drug,
and Cosmetic Act; advises on the
necessity to ban a device; and responds
to requests from the Agency to review
and make recommendations on specific
issues or problems concerning the safety
and effectiveness of devices.
a letter via email stating that interest to
FDA contact (see FOR FURTHER
INFORMATION CONTACT) within 30 days of
publication of this document (see
DATES). Within the subsequent 30 days,
FDA will send a notification to each
organization that has expressed an
interest, attaching a complete list of all
such organizations; and a list of all
nominees along with their current
re´sume´s. The letter will also state that
it is the responsibility of the interested
organizations to confer with one another
and to select a candidate, within 60
days after the receipt of the FDA letter,
to serve as the nonvoting member to
represent industry interests for the
committee. The interested organizations
are not bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within 60 days,
the Commissioner will select the
nonvoting member to represent industry
interests.
III. Application Procedure
Individuals may self-nominate, and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Contact
information, a current curriculum vitae,
and the name of the committee of
interest should be sent to the FDA
Advisory Committee Membership
Nomination Portal (see ADDRESSES)
within 30 days of publication of this
document (see DATES). FDA will forward
all nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process.)
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: January 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01057 Filed 1–22–20; 8:45 am]
BILLING CODE 4164–01–P
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Product-Specific Guidance for
Levonorgestrel; Intrauterine Device;
Revised Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a revised
draft guidance for industry, entitled
‘‘Draft Guidance for Levonorgestrel.’’
The revised draft guidance, when
finalized, will provide product-specific
recommendations on, among other
things, the design of bioequivalence
(BE) studies to support abbreviated new
drug applications (ANDAs) for a
levonorgestrel intrauterine device.
DATES: Submit either electronic or
written comments on the draft guidance
by March 23, 2020 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
E:\FR\FM\23JAN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 15 (Thursday, January 23, 2020)]
[Notices]
[Pages 3923-3924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01057]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0008]
Request for Nominations From Industry Organizations Interested in
Participating in the Selection Process for Nonvoting Industry
Representatives and Request for Nominations for Nonvoting Industry
Representatives on the Blood Products Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is requesting
that any industry organizations interested in participating in the
selection of a nonvoting industry representative to serve on the Blood
Products Advisory Committee (BPAC) for the Center for Biologics
Evaluation and Research notify FDA in writing. FDA is also requesting
nominations for a nonvoting industry representative(s) to serve on the
BPAC. A nominee may either be self-nominated or nominated by an
organization to serve as a nonvoting industry representative.
Nominations will be accepted for future vacancies effective October 1,
2020, with this notice.
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to FDA by February
24, 2020 (see sections I and II of this document for further details).
Concurrently, nomination materials for prospective candidates should be
sent to FDA by February 24, 2020.
ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of nonvoting
industry representative nominations should be sent via email to
Christina Vert (see FOR FURTHER INFORMATION CONTACT). All nominations
for nonvoting industry representatives must be submitted electronically
by accessing the FDA Advisory Committee Membership Nomination Portal
at: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm. Information about becoming a member of an FDA advisory
committee can also
[[Page 3924]]
be obtained by visiting FDA's website at: https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Christina Vert, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6268, Silver Spring, MD 20993-0002, 240-
402-8054, Fax: 301-595-1309, email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting
industry representative(s) to the following advisory committee:
I. Blood Products Advisory Committee
BPAC reviews and evaluates available data concerning the safety,
effectiveness, and appropriate use of blood, products derived from
blood and serum or biotechnology which are intended for use in the
diagnosis, prevention, or treatment of human diseases, and, as
required, any other product for which FDA has regulatory
responsibility, and advises the Commissioner of Food and Drugs (the
Commissioner) of its findings regarding screening and testing (to
determine eligibility) of donors and labeling of the products, on
clinical and laboratory studies involving such products, on the
affirmation or revocation of biological products licenses, and on the
quality and relevance of FDA's research program which provides the
scientific support for regulating these agents. BPAC will function at
times as a medical device panel under the Federal Food, Drug, and
Cosmetic Act Medical Device Amendments of 1976. As such, BPAC
recommends classification of devices subject to its review into
regulatory categories; recommends the assignment of a priority for the
application of regulatory requirements for devices classified in the
standards or premarket approval category; advises on formulation of
product development protocols and reviews premarket approval
applications for those devices to recommend changes in classification
as appropriate; recommends exemption of certain devices from the
application of portions of the Federal Food, Drug, and Cosmetic Act;
advises on the necessity to ban a device; and responds to requests from
the Agency to review and make recommendations on specific issues or
problems concerning the safety and effectiveness of devices.
II. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter via email stating that interest to FDA
contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of
publication of this document (see DATES). Within the subsequent 30
days, FDA will send a notification to each organization that has
expressed an interest, attaching a complete list of all such
organizations; and a list of all nominees along with their current
r[eacute]sum[eacute]s. The letter will also state that it is the
responsibility of the interested organizations to confer with one
another and to select a candidate, within 60 days after the receipt of
the FDA letter, to serve as the nonvoting member to represent industry
interests for the committee. The interested organizations are not bound
by the list of nominees in selecting a candidate. However, if no
individual is selected within 60 days, the Commissioner will select the
nonvoting member to represent industry interests.
III. Application Procedure
Individuals may self-nominate, and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Contact information, a current curriculum vitae, and
the name of the committee of interest should be sent to the FDA
Advisory Committee Membership Nomination Portal (see ADDRESSES) within
30 days of publication of this document (see DATES). FDA will forward
all nominations to the organizations expressing interest in
participating in the selection process for the committee. (Persons who
nominate themselves as nonvoting industry representatives will not
participate in the selection process.)
FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore, encourages nominations of
appropriately qualified candidates from these groups.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: January 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01057 Filed 1-22-20; 8:45 am]
BILLING CODE 4164-01-P
