Request for Nominations for Voting Members on a Public Advisory Committee; Blood Products Advisory Committee, 16220-16221 [2021-06259]
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Federal Register / Vol. 86, No. 57 / Friday, March 26, 2021 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
Location: N1–14–56, 7500 Security
Blvd., Baltimore, MD 21244–1850.
FOR FURTHER INFORMATION CONTACT: If
you have questions about the matching
program, you may contact Anne Pesto,
Senior Advisor, Marketplace Eligibility
and Enrollment Group, Center for
Consumer Information and Insurance
Oversight, Centers for Medicare &
Medicaid Services, at 410–786–3492, by
email at anne.pesto@cms.hhs.gov, or by
mail at 7500 Security Blvd., Baltimore,
MD 21244.
SUPPLEMENTARY INFORMATION: The
Privacy Act of 1974, as amended (5
U.S.C. 552a) provides certain
protections for individuals applying for
and receiving federal benefits. The law
governs the use of computer matching
by federal agencies when records in a
system of records (meaning, federal
agency records about individuals
retrieved by name or other personal
identifier) are matched with records of
other federal or non-federal agencies.
The Privacy Act requires agencies
involved in a matching program to:
1. Enter into a written agreement,
which must be prepared in accordance
with the Privacy Act, approved by the
Data Integrity Board of each source and
recipient federal agency, provided to
Congress and the Office of Management
and Budget (OMB), and made available
to the public, as required by 5 U.S.C.
552a(o), (u)(3)(A), and (u)(4).
2. Notify the individuals whose
information will be used in the
matching program that the information
they provide is subject to verification
through matching, as required by 5
U.S.C. 552a(o)(1)(D).
3. Verify match findings before
suspending, terminating, reducing, or
making a final denial of an individual’s
benefits or payments or taking other
adverse action against the individual, as
required by 5 U.S.C. 552a(p).
4. Report the matching program to
Congress and the OMB, in advance and
annually, as required by 5 U.S.C.
552a(o) (2)(A)(i), (r), and (u)(3)(D).
5. Publish advance notice of the
matching program in the Federal
Register as required by 5 U.S.C.
552a(e)(12).
This matching program meets these
requirements.
Barbara Demopulos,
Privacy Advisor, Division of Security, Privacy
Policy and Governance, Office of Information
Technology, Centers for Medicare & Medicaid
Services.
Participating Agencies
The Department of Health and Human
Services (HHS), Centers for Medicare &
Medicaid Services (CMS) is the
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17:14 Mar 25, 2021
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recipient agency, and the Peace Corps is
the source agency.
Authority for Conducting the Matching
Program
The principal statutory authority for
the matching program is 42 U.S.C.
18001, et seq.
Purpose(s)
The purpose of the matching program
is to assist CMS in determining
individuals’ eligibility for financial
assistance in paying for private health
insurance coverage. In this matching
program, the Peace Corps provides CMS
with data identifying all Peace Corps
volunteers, which CMS makes available
to state administering entities (AEs)
through a data services hub, under a
separate matching agreement. CMS and
AEs use the Peace Corps data to verify
whether an individual who is applying
for or is enrolled in private health
insurance coverage under a qualified
health plan through a federallyfacilitated or state-based health
insurance exchange is eligible for
coverage under a Peace Corps health
benefit plan, for the purpose of
determining the individual’s eligibility
for financial assistance (including an
advance tax credit and cost sharing
reduction, which are types of insurance
affordability programs) in paying for
private health insurance coverage. Peace
Corps health benefit plans provide
minimum essential coverage, and
eligibility for such plans precludes
eligibility for financial assistance in
paying for private coverage. The data
provided by the Peace Corps under this
matching program will be used by CMS
and AEs to authenticate identity,
determine eligibility for financial
assistance, and determine the amount of
any financial assistance.
Categories of Individuals
The categories of individuals whose
information is involved in the matching
program are:
• Active and recently separated Peace
Corps volunteers, identified in data
CMS receives from the Peace Corps; and
• Consumers who apply for or are
enrolled in private insurance coverage
under a qualified health plan through a
federally-facilitated health insurance
exchange (and other relevant
individuals, such as applicants’ and
enrollees’ household members), whose
records are matched against the data
CMS receives from the Peace Corps.
Categories of Records
The categories of records which will
be provided by the Peace Corps to CMS
in this matching program are identity
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records and minimum essential
coverage period records, consisting of
these data elements: Last name, middle
initial, first name, and date of birth.
CMS will not send any data about
individual applicants/enrollees to the
Peace Corps in order to receive this data
about Peace Corps volunteers.
A. System of Records Maintained by
CMS
CMS Health Insurance Exchanges
System (HIX), CMS System No. 09–70–
0560, last published in full at 78 FR
63211 (Oct. 23, 2013), as amended at 83
FR 6591 (Feb. 14, 2018).
B. System of Records Maintained by
Peace Corps
The Peace Corps SORN that supports
this matching program is PC–17 Peace
Corps, Volunteer Applicant and Service
Records System, published at 50 FR
1950 (Jan. 14, 1985) and partially
amended at 65 FR 63641 (Oct. 24, 2000),
72 FR 44878 (Aug. 9, 2007), 75 FR
53000 (Aug. 30, 2010), and 79 FR 41599
(July 16, 2014). Routine Use (i)
published at 50 FR 1950 (Jan. 14, 1985),
which permits disclosures ‘‘to verify
active or former volunteer service,’’
authorizes the Peace Corps’ disclosures
to CMS.
[FR Doc. 2021–06321 Filed 3–25–21; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0573]
Request for Nominations for Voting
Members on a Public Advisory
Committee; Blood Products Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on the Blood Products Advisory
Committee (the Committee) in the
Center for Biologics Evaluation and
Research. Nominations will be accepted
for 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. This notice is not for
SUMMARY:
E:\FR\FM\26MRN1.SGM
26MRN1
Federal Register / Vol. 86, No. 57 / Friday, March 26, 2021 / Notices
nominations for non-voting industry
representatives.
Nominations received on or
before May 25, 2021 will be given first
consideration for membership on the
Blood Products Advisory Committee.
Nominations received after May 25,
2021 will be considered for nomination
to the Committee as later vacancies
occur.
DATES:
All nominations for
membership should be sent
electronically by logging into the FDA
Advisory Nomination Portal: https://
www.accessdata.fda.gov/scripts/
factrsportal/factrs/index.cfm.
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.
ADDRESSES:
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:
BPAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
members to fill upcoming vacancies on
the Blood Products Advisory
Committee.
khammond on DSKJM1Z7X2PROD with NOTICES
I. General Description of the Committee
Duties
The Committee reviews and evaluates
available data concerning the safety,
effectiveness, and appropriate use of
blood, products derived from blood and
serum or biotechnology that 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. The Committee also
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
that provides the scientific support for
regulating these agents. The Committee
will function at times as a medical
device panel under the Federal Food,
Drug, and Cosmetic Act (FD&C Act)
VerDate Sep<11>2014
17:14 Mar 25, 2021
Jkt 253001
Medical Device Amendments of 1976.
As such, the Committee 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 FD&C 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. Criteria for Voting Members
The Committee consists of a core of
17 voting members, including the Chair.
Members and the Chair are selected by
the Commissioner or designee from
among authorities knowledgeable in the
fields of clinical and administrative
medicine, hematology, immunology,
blood banking, surgery, internal
medicine, biochemistry, engineering,
biological and physical sciences,
biotechnology, computer technology,
statistics, epidemiology, sociology/
ethics, and other related professions.
Almost all non-Federal members of this
committee serve as Special Government
Employees. Members will be invited to
serve for terms of up to 4 years.
III. Nomination Procedures
Any interested person may nominate
one or more qualified persons for
membership on the advisory committee.
Self-nominations are also accepted.
Nominations must include a current,
complete re´sume´ or curriculum vitae for
each nominee, including current
business 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 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,
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16221
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: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–06259 Filed 3–25–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–N–1671, FDA–
2014–N–0386, FDA–2011–N–0076, FDA–
2008–N–0312, FDA–2020–N–1677, FDA–
2014–N–1072, and FDA–2019–N–5900]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUMMARY:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\26MRN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 57 (Friday, March 26, 2021)]
[Notices]
[Pages 16220-16221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06259]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0573]
Request for Nominations for Voting Members on a Public Advisory
Committee; Blood Products Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the Blood Products Advisory
Committee (the Committee) in the Center for Biologics Evaluation and
Research. Nominations will be accepted for 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. This notice is not for
[[Page 16221]]
nominations for non-voting industry representatives.
DATES: Nominations received on or before May 25, 2021 will be given
first consideration for membership on the Blood Products Advisory
Committee. Nominations received after May 25, 2021 will be considered
for nomination to the Committee as later vacancies occur.
ADDRESSES: All nominations for membership should be sent electronically
by logging into the FDA Advisory Nomination Portal: https://www.accessdata.fda.gov/scripts/factrsportal/factrs/index.cfm.
Information about becoming a member on an FDA advisory committee can
also be obtained by visiting FDA's website at https://www.fda.gov/advisory-committees.
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: FDA is requesting nominations for voting
members to fill upcoming vacancies on the Blood Products Advisory
Committee.
I. General Description of the Committee Duties
The Committee reviews and evaluates available data concerning the
safety, effectiveness, and appropriate use of blood, products derived
from blood and serum or biotechnology that 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. The Committee also 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 that provides
the scientific support for regulating these agents. The Committee will
function at times as a medical device panel under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) Medical Device Amendments of 1976. As
such, the Committee 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 FD&C 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. Criteria for Voting Members
The Committee consists of a core of 17 voting members, including
the Chair. Members and the Chair are selected by the Commissioner or
designee from among authorities knowledgeable in the fields of clinical
and administrative medicine, hematology, immunology, blood banking,
surgery, internal medicine, biochemistry, engineering, biological and
physical sciences, biotechnology, computer technology, statistics,
epidemiology, sociology/ethics, and other related professions. Almost
all non-Federal members of this committee serve as Special Government
Employees. Members will be invited to serve for terms of up to 4 years.
III. Nomination Procedures
Any interested person may nominate one or more qualified persons
for membership on the advisory 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, 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 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: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06259 Filed 3-25-21; 8:45 am]
BILLING CODE 4164-01-P
