Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee, 3052-3053 [2020-00733]
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Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity: ACF Program Instruction—
Children’s Justice Act (OMB #0970–
0425)
Children’s Bureau,
Administration for Children and
Families, HHS.
ACTION: Request for public comment.
AGENCY:
The Administration for
Children and Families (ACF) is
requesting a 3-year extension of the
Children’s Justice Act Program
Instruction (OMB #0970–0425,
expiration 4/30/2020). There are no
changes requested to the form.
DATES: 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
SUMMARY:
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 infocollection@
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: ACF
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: The Program Instruction,
prepared in response to the enactment
of the Children’s Justice Act (CJA), Title
II of Public Law 111–320, Child Abuse
Prevention and Treatment Act
Reauthorization of 2010, provides
direction to the states and territories to
accomplish the purposes of assisting
states in developing, establishing, and
operating programs designed to
improve: (1) The assessment and
investigation of suspected child abuse
and neglect cases, including cases of
suspected child sexual abuse and
exploitation, in a manner that limits
additional trauma to the child and the
child’s family; (2) the assessment and
investigation of cases of suspected child
abuse-related fatalities and suspected
child neglect-related fatalities; (3) the
investigation and prosecution of cases of
child abuse and neglect, including child
sexual abuse and exploitation; and (4)
the assessment and investigation of
cases involving children with
disabilities or serious health-related
problems who are suspected victims of
child abuse or neglect. This Program
Instruction contains information
collection requirements that are found
in Public Law 111–320 at sections
107(b) and 107(d), and pursuant to
receiving a grant award. The
information submitted will be used by
the agency to ensure compliance with
the statute; to monitor, evaluate, and
measure grantee achievements in
addressing the investigation and
prosecution of child abuse and neglect;
and to report to Congress.
Respondents: State Governments.
ANNUAL BURDEN ESTIMATES
Instrument
Total number of
respondents
Annual
number of
responses per
respondent
Average
burden hours
per response
Annual burden
hours
Application and Annual Report ................................................................
52
1
60
3,120
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Estimated Total Annual Burden
Hours: 3,120.
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: 42 U.S.C. 5106c Sec. 107(b)(4)
and 42 U.S.C. 5106 Sec. 107(B)(5).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–00739 Filed 1–16–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–2495]
Request for Nominations for Voting
Members on a Public Advisory
Committee; Technical Electronic
Product Radiation Safety Standards
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for members to serve on
the Technical Electronic Product
Radiation Safety Standards Committee
(TEPRSSC) in the Center for Devices
and Radiological Health. Nominations
will be accepted for current and
upcoming vacancies effective with this
notice.
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
SUMMARY:
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committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
Nominations received on or
before March 17, 2020, will be given
first consideration for membership on
TEPRSSC. Nominations received after
March 17, 2020, will be considered for
nomination to the committee as later
vacancies occur.
DATES:
All nominations for
membership should be sent
electronically by accessing FDA’s
Advisory Committee Membership
Nomination Portal at https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member on an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
ADDRESSES:
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Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Notices
FOR FURTHER INFORMATION CONTACT:
Patricio G. Garcia, Division of
Management Services, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5216,
Silver Spring, MD 20993–0002, 301–
796–6875, email: Patricio.Garcia@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
members on TEPRSSC that include
three general public representatives.
I. General Description of the
Committee’s Duties
The committee provides advice and
consultation to the Commissioner of
Food and Drugs (Commissioner) on the
technical feasibility, reasonableness,
and practicability of performance
standards for electronic products to
control the emission of radiation from
such products, and may recommend
electronic product radiation safety
standards to the Commissioner for
consideration.
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II. Criteria for Voting Members
The committee consists of a core of 15
voting members including the Chair.
Members and the Chair are selected by
the Commissioner or designee from
among authorities knowledgeable in the
fields of science or engineering,
applicable to electronic product
radiation safety. Members will be
invited to serve for overlapping terms of
up to 4 years. Terms of more than 2
years are contingent upon the renewal
of the committee by appropriate action
prior to its expiration.
III. Nomination Procedures
Any interested person may nominate
one or more qualified individuals for
membership on the committee. Selfnominations are also accepted.
Nominations must include a current,
complete re´sume´ or curriculum vitae for
each nominee, including current
business address and/or home address,
telephone number, and email address if
available and a signed copy of the
Acknowledgement and Consent form
available at the FDA Advisory
Nomination Portal (see ADDRESSES).
Nominations must also specify the
advisory committee for which the
nominee is recommended. Nominations
must also acknowledge that the
nominee is aware of the nomination
unless self-nominated. FDA will ask
potential candidates to provide detailed
information concerning such matters
related to financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflicts of interest.
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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 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–00733 Filed 1–16–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0578]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; General Licensing
Provisions: Biologics License
Application, Changes to an Approved
Application, Labeling, Revocation and
Suspension, Postmarketing Studies
Status Reports, and Form FDA 356h
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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.
DATES: Fax written comments on the
collection of information by February
18, 2020.
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_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0338. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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General Licensing Provisions: Biologics
License Application, Changes to an
Approved Application, Labeling,
Revocation and Suspension,
Postmarketing Studies Status Reports,
and Form FDA 356h
OMB Control Number 0910–0338—
Extension
Under section 351 of the Public
Health Services Act (42 U.S.C. 262),
manufacturers of biological products
must submit a license application for
FDA review and approval before
marketing a biological product in
interstate commerce. Licenses may be
issued only upon showing that the
establishment and the products for
which a license is desired meets
standards prescribed in regulations
designed to ensure the continued safety,
purity, and potency of such products.
All such licenses are issued, suspended,
and revoked as prescribed by
regulations in part 601 (21 CFR part
601).
Section 130(a) of the Food and Drug
Administration Modernization Act of
1997 (Pub. L. 105–115) amended the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) by adding a new provision
(section 506B of the FD&C Act (21
U.S.C. 356b)) requiring reports of
postmarketing studies for approved
human drugs and licensed biological
products. Section 506B of the FD&C Act
provides FDA with additional authority
to monitor the progress of postmarketing
studies that applicants have made a
commitment to conduct and requires
the Agency to make publicly available
information that pertains to the status of
these studies. Under section 506B(a) of
the FD&C Act, applicants that have
committed to conduct a postmarketing
study for an approved human drug or
licensed biological product must submit
to FDA a status report of the progress of
the study or the reasons for the failure
of the applicant to conduct the study.
This report must be submitted within 1
year after the U.S. approval of the
application and then annually until the
study is completed or terminated.
A summary of the collection of
information requirements follows:
Section 601.2(a) (21 CFR 601.2(a))
requires a manufacturer of a biological
product to submit an application on
forms prescribed for such purposes with
accompanying data and information,
including certain labeling information,
to FDA for approval to market a product
in interstate commerce. The container
and package labeling requirements are
provided under §§ 610.60 through
610.65 (21 CFR 610.60 through 610.65).
The estimate for these regulations is
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]]>Agencies
[Federal Register Volume 85, Number 12 (Friday, January 17, 2020)]
[Notices]
[Pages 3052-3053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00733]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-2495]
Request for Nominations for Voting Members on a Public Advisory
Committee; Technical Electronic Product Radiation Safety Standards
Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for members to serve on the Technical Electronic Product
Radiation Safety Standards Committee (TEPRSSC) in the Center for
Devices and Radiological Health. Nominations will be accepted for
current and upcoming vacancies effective with this notice.
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.
DATES: Nominations received on or before March 17, 2020, will be given
first consideration for membership on TEPRSSC. Nominations received
after March 17, 2020, will be considered for nomination to the
committee as later vacancies occur.
ADDRESSES: All nominations for membership should be sent electronically
by accessing FDA's Advisory Committee Membership Nomination Portal at
https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or
by mail to Advisory Committee Oversight and Management Staff, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993-0002. Information about becoming a member on an
FDA advisory committee can also be obtained by visiting FDA's website
at https://www.fda.gov/AdvisoryCommittees/default.htm.
[[Page 3053]]
FOR FURTHER INFORMATION CONTACT: Patricio G. Garcia, Division of
Management Services, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5216,
Silver Spring, MD 20993-0002, 301-796-6875, email:
[email protected].
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members on TEPRSSC that include three general public representatives.
I. General Description of the Committee's Duties
The committee provides advice and consultation to the Commissioner
of Food and Drugs (Commissioner) on the technical feasibility,
reasonableness, and practicability of performance standards for
electronic products to control the emission of radiation from such
products, and may recommend electronic product radiation safety
standards to the Commissioner for consideration.
II. Criteria for Voting Members
The committee consists of a core of 15 voting members including the
Chair. Members and the Chair are selected by the Commissioner or
designee from among authorities knowledgeable in the fields of science
or engineering, applicable to electronic product radiation safety.
Members will be invited to serve for overlapping terms of up to 4
years. Terms of more than 2 years are contingent upon the renewal of
the committee by appropriate action prior to its expiration.
III. Nomination Procedures
Any interested person may nominate one or more qualified
individuals for membership on the committee. Self-nominations are also
accepted. Nominations must include a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee, including
current business address and/or home address, telephone number, and
email address if available and a signed copy of the Acknowledgement and
Consent form available at the FDA Advisory Nomination Portal (see
ADDRESSES). Nominations must also specify the advisory committee for
which the nominee is recommended. Nominations must also acknowledge
that the nominee is aware of the nomination unless self-nominated. FDA
will ask potential candidates to provide detailed information
concerning such matters related to financial holdings, employment, and
research grants and/or contracts to permit evaluation of possible
sources of conflicts of interest.
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 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00733 Filed 1-16-20; 8:45 am]
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