Advisory Committee; Cellular, Tissue and Gene Therapies Advisory Committee; Renewal
| Citation | 85 FR 84349 |
| Record Number | 2020-28561 |
| Published date | 28 December 2020 |
| Section | Notices |
| Court | Food And Drug Administration |
84349
Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Notices
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the
SUPPLEMENTARY
INFORMATION
section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT
:
Nancy Guan, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–348–1549; or Stephen Ripley,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911.
SUPPLEMENTARY INFORMATION
:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Content of the Risk
Evaluation and Mitigation Strategies
Document Using Structured Product
Labeling.’’ FDASIA amended the FD&C
Act to require that certain submissions
under the FD&C Act and the PHS Act be
submitted in electronic format,
beginning no earlier than 24 months
after issuance of final guidance on
electronic format for submissions. This
guidance describes how FDA plans to
implement the requirements for the
electronic submission of REMS
documents in certain submissions under
NDAs, ANDAs, and certain BLAs,
beginning December 28, 2022.
This guidance finalizes the draft
guidance entitled ‘‘Providing Regulatory
Submissions in Electronic Format—
Content of the Risk Evaluation and
Mitigation Strategies Document Using
Structured Product Labeling’’ issued
September 5, 2017 (82 FR 41968). FDA
has considered all the public comments
received on the draft guidance in
finalizing this guidance. FDA made
editorial changes to improve clarity and
address comments as appropriate. FDA
also amended language in Part III.C of
the guidance to reflect the recent
publication of exemption and waiver
criteria for eCTD submissions in a
separate guidance.
FDA guidances ordinarily contain
standard language explaining that
guidances should be viewed only as
recommendations unless specific
regulatory or statutory requirements are
cited. FDA is not including this
standard language in this guidance
because this guidance contains binding
provisions. In section 745A(a) of the
FD&C Act, Congress granted explicit
authorization to FDA to specify in
guidance the format for the electronic
submissions required under that
section. Accordingly, this guidance
explains such requirements under
section 745A(a) of the FD&C Act,
indicated by the use of the words must
or required, and therefore is not subject
to the usual restrictions in FDA’s good
guidance practice regulations, such as
the requirement that guidances not
establish legally enforceable
responsibilities. See 21 CFR 10.115(d).
This guidance represents the Agency’s
current thinking on ‘‘Providing
Regulatory Submissions in Electronic
Format—Content of the Risk Evaluation
and Mitigation Strategies Document
Using Structured Product Labeling.’’
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
vaccines-blood-biologics/guidance-
compliance-regulatory-information-
biologics/biologics-guidances, or https://
www.regulations.gov.
Dated: December 21, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–28560 Filed 12–23–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0008]
Advisory Committee; Cellular, Tissue
and Gene Therapies Advisory
Committee; Renewal
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice; renewal of Federal
advisory committee.
SUMMARY
: The Food and Drug
Administration (FDA) is announcing the
renewal of the Cellular, Tissue and Gene
Therapies Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Cellular, Tissue
and Gene Therapies Advisory
Committee for an additional 2 years
beyond the charter expiration date. The
new charter will be in effect until the
October 28, 2022, expiration date.
DATES
: Authority for the Cellular, Tissue
and Gene Therapies Advisory
Committee will expire on October 28,
2022, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT
:
Prabhakara Atreya, Division of
Scientific Advisors and Consultants,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10993 New Hampshire
Ave., Bldg. 71, Rm. 6306, Silver Spring,
MD 20993–0002, 240–402–8006,
Prabhakara.Atreya@fda.hhs.gov.
SUPPLEMENTARY INFORMATION
: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Cellular, Tissue and Gene Therapies
Advisory Committee (the Committee).
The Committee is a discretionary
Federal advisory committee established
to provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
available data relating to the safety,
effectiveness, and appropriate use of
human cells, human tissues, gene
transfer therapies, and
xenotransplantation products, which are
intended for transplantation,
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84350
Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Notices
implantation, infusion, and transfer in
the prevention and treatment of a broad
spectrum of human diseases and in the
reconstruction, repair, or replacement of
tissues for various conditions. The
Committee also considers the quality
and relevance of FDA’s research
program, which provides scientific
support for the regulation of these
products, and makes appropriate
recommendations to the Commissioner.
The Committee shall consist of a core
of 13 voting members, including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of cellular
therapies, tissue transplantation, gene
transfer therapies, and
xenotransplantation (biostatistics,
bioethics, hematology/oncology, human
tissues and transplantation,
reproductive medicine, general
medicine, and various medical
specialties, including surgery and
oncology, immunology, virology,
molecular biology, cell biology,
developmental biology, tumor biology,
biochemistry, rDNA technology, nuclear
medicine, gene therapy, infectious
diseases, and cellular kinetics).
Members will be invited to serve for
overlapping terms of up to 4 years.
Almost all non-Federal members of this
Committee serve as Special Government
Employees. The core of voting members
may include one technically qualified
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumer-
oriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting member who is
identified with industry interests.
The Commissioner or designee shall
have the authority to select members of
other scientific and technical FDA
advisory committees (normally not to
exceed 10 members) to serve
temporarily as voting members and to
designate consultants to serve
temporarily as voting members when:
(1) expertise is required that is not
available among current voting standing
members of the Committee (when
additional voting members are added to
the Committee to provide needed
expertise, a quorum will be based on the
combined total of regular and added
members) or (2) to comprise a quorum
when, because of unforeseen
circumstances, a quorum is or will be
lacking. Because of the size of the
Committee and the variety in the types
of issues that it will consider, FDA may,
in connection with a particular
committee meeting, specify a quorum
that is less than a majority of the current
voting members. The Agency’s
regulations (21 CFR 14.22(d)) authorize
a committee charter to specify quorum
requirements.
If functioning as a medical device
panel, a non-voting representative of
consumer interests and a non-voting
representative of industry interests will
be included in addition to the voting
members.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
cellular-tissue-and-gene-therapies-
advisory-committee/charter-cellular-
tissue-and-gene-therapies-advisory-
committee or by contacting the
Designated Federal Officer (see
FOR
FURTHER INFORMATION CONTACT
). In light
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at http://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: December 18, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–28561 Filed 12–23–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
AGENCY
: Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION
: Notice.
SUMMARY
: HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the Program), as required by
Section 2112(b)(2) of the Public Health
Service (PHS) Act, as amended. While
the Secretary of HHS is named as the
respondent in all proceedings brought
by the filing of petitions for
compensation under the Program, the
United States Court of Federal Claims is
charged by statute with responsibility
for considering and acting upon the
petitions.
FOR FURTHER INFORMATION CONTACT
: For
information about requirements for
filing petitions, and the Program in
general, contact Lisa L. Reyes, Clerk of
Court, United States Court of Federal
Claims, 717 Madison Place NW,
Washington, DC 20005, (202) 357–6400.
For information on HRSA’s role in the
Program, contact the Director, National
Vaccine Injury Compensation Program,
5600 Fishers Lane, Room 08N146B,
Rockville, Maryland 20857; (301) 443–
6593, or visit our website at: http://
www.hrsa.gov/vaccinecompensation/
index.html.
SUPPLEMENTARY INFORMATION
: The
Program provides a system of no-fault
compensation individuals who have
been injured by specified childhood
vaccines. Subtitle 2 of Title XXI of the
PHS Act, 42 U.S.C. 300aa–10 et seq.,
provides that those seeking
compensation are to file a petition with
the United States Court of Federal
Claims and to serve a copy of the
petition to the Secretary of HHS, who is
named as the respondent in each
proceeding. The Secretary has delegated
this responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at 42 CFR
100.3. This Table lists for each covered
childhood vaccine the conditions that
may lead to compensation and, for each
condition, the time period for
occurrence of the first symptom or
manifestation of onset or of significant
aggravation after vaccine
administration. Compensation may also
be awarded for conditions not listed in
the Table and for conditions that are
manifested outside the time periods
specified in the Table, but only if the
petitioner shows that the condition was
caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that
‘‘[w]ithin 30 days after the Secretary
receives service of any petition filed
under section 2111 the Secretary shall
publish notice of such petition in the
Federal Register.’’ Set forth below is a
list of petitions received by HRSA on
November 1, 2020, through November
30, 2020. This list provides the name of
petitioner, city and state of vaccination
(if unknown then city and state of
person or attorney filing claim), and
case number. In cases where the Court
has redacted the name of a petitioner
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