Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Notices 84349 

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received on the draft guidance in 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/guidancecompliance-regulatory-informationbiologics/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 consumeroriented 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-therapiesadvisory-committee/charter-cellulartissue-and-gene-therapies-advisorycommittee 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 


tkelley on DSKBCP9HB2PROD with NOTICES