52156 Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 

TABLE 1—STATUS OF DRAFT GUIDANCE Q&AS AND FINAL GUIDANCE Q&AS—Continued 

Q&A category Q&A No. Previous guidance 

location 

Current guidance 

location 

Q.II.3 ............................................. Final .............................................. Final. 

Part III. Exclusivity ......................... Q.III.1 ............................................ Final .............................................. Final. 

Q.III.2 ............................................ Final .............................................. Final. 

* The draft Q&A continues to be available in the New and Revised Draft Q&A Guidance (Revision 3). All other draft Q&As are available in the 

Additional Draft Q&A Guidance. 

This guidance finalizes all but three of 

the Q&As that were included in the 

draft guidance ‘‘New and Revised Draft 

Q&As on Biosimilar Development and 

the BPCI Act (Revision 2)’’ issued on 

December 12, 2018. FDA considered 

comments it received regarding these 

Q&As, and made changes to the Q&As, 

as appropriate; for example, providing 

additional and clearer information in 

Q.I.16 and providing additional 

information about text in the labeling 

for a biosimilar in Q.I.22. FDA also 

made certain clarifying and editorial 

changes to update previously finalized 

Q&As. Editorial changes were made 

primarily for clarification. 

FDA has retained Q.I.12 in draft and 

transferred it to ‘‘New and Revised Draft 

Q&As on Biosimilar Development and 

the BPCI Act (Revision 3).’’ This draft 

Q&A addresses how an applicant can 

demonstrate that its proposed injectable 

biosimilar product or proposed 

injectable interchangeable product has 

the same ‘‘strength’’ as the reference 

product. FDA withdrew Q.I.23, which 

addressed a process for obtaining 

certain letters related to reference 

product access for testing for products 

with risk evaluation and mitigation 

strategy with elements to assure safe 

use. In light of the enactment of the 

Further Consolidated Appropriations 

Act, 2020 (FCA Act) (Pub. L. 116–94), 

which includes provisions related to 

this topic (see Division N, section 610, 

of the FCA Act (21 U.S.C. 355–2)), FDA 

intends to issue guidance describing 

how the existing process for obtaining 

these letters is being aligned with the 

framework set forth in the new law. 

FDA also withdrew Q.II.1, which 

addressed the definition of ‘‘protein.’’ 

For information on the definition of 

‘‘protein’’ in section 351(i)(1) of the PHS 

Act, see the final rule entitled 

‘‘Definition of the Term ‘Biological 

Product’ ’’ (85 FR 10057, February 21, 

2020; 21 CFR 600.3(h)(6)). 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Questions and 

Answers on Biosimilar Development 

and the BPCI Act.’’ It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. 

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 312 for 

submission of an investigational new 

drug application have been approved 

under OMB control number 0910–0014. 

The collections of information in 21 

CFR part 314.50 for submission of a new 

drug application have been approved 

under OMB control number 0910–0001. 

The collections of information in 

section 351(a) of the PHS Act and 21 

CFR part 601 for submission of a 

biologics license application (BLA) have 

been approved under OMB control 

number 0910–0338. The collections of 

information in section 351(k) of the PHS 

Act and 21 CFR part 601 for submission 

of a BLA have been approved under 

OMB control number 0910–0719. 

III. Electronic Access 

Persons with access to the internet 

may obtain the final guidance at either 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https:// 

www.regulations.gov. 

Dated: September 14, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–20255 Filed 9–17–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the National Advisory 

Council on Migrant Health 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the Secretary’s 

National Advisory Council on Migrant 

Health (NACMH or Council) has 

scheduled a public meeting. Information 

about NACMH and the agenda for this 

meeting can be found on the NACMH 

website at: https://bphc.hrsa.gov/ 

qualityimprovement/strategic

partnerships/nacmh. 

DATES: November 2–5, 2021; 12:30 

p.m.–4:30 p.m. Eastern Time each day. 

ADDRESSES: This meeting will be held 

by webinar. Instructions for joining the 

meeting will be posted on the NACMH 

website 30 business days before the 

meeting date. For meeting information 

updates, go to the NACMH website at: 

https://bphc.hrsa.gov/quality

improvement/strategicpartnerships/ 

nacmh. 

FOR FURTHER INFORMATION CONTACT: 

Esther Paul, NACMH Designated 

Federal Officer, Strategic Initiatives and 

Planning Division, Office of Policy and 

Program Development, Bureau of 

Primary Health Care, HRSA, 5600 

Fishers Lane, Rockville, Maryland 

20857; 301–594–4300; or epaul@

hrsa.gov. 

SUPPLEMENTARY INFORMATION: NACMH 

is a non-discretionary advisory body 

mandated by the Public Health Service 

Act, Title 42 U.S.C. 218, to advise, 

consult with, and make 

recommendations to the Secretary of the 

Department of Health and Human 

Services and the Administrator of HRSA 

regarding the organization, operation, 

selection, and funding of migrant health 

centers and other entities funded under 

section 330(g) of the Public Health 

Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 52157 

Service Act (42 U.S.C. 254b). NACMH 

meets twice each calendar year, or at the 

discretion of the Designated Federal 

Officer in consultation with the 

NACMH Chair. 

Agenda items and meeting times are 

subject to change as priority dictate. The 

agenda items for the meeting may 

include topics and issues related to 

migratory and seasonal agricultural 

worker health. Refer to the NACMH 

website listed above for any updated 

information concerning the meeting. 

Members of the public will have the 

opportunity to provide comments. 

Public participants may submit written 

statements in advance of the scheduled 

meeting. Oral comments will be 

honored in the order requested and may 

be limited as time allows. Requests to 

submit a written statement or make oral 

comments to the NACMH should be 

sent to Esther Paul using the contact 

information above at least 5 business 

days before the meeting. 

Individuals who plan to participate 

and need special assistance or another 

reasonable accommodation should 

notify Esther Paul at the address and 

phone number listed above at least 10 

business days before the meeting. 

Registration is required to participate in 

the meeting prior to entry. Registration 

and meeting attendance instructions 

will be posted on the NACMH website 

30 business days before the meeting 

date. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–20231 Filed 9–17–21; 8:45 am] 

BILLING CODE 4165–15–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 

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 for certain 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 

August 1, 2021, through August 31, 

2021. 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 

and/or the case number, the list reflects 

such redaction. 

Section 2112(b)(2) also provides that 

the special master ‘‘shall afford all 

interested persons an opportunity to 

submit relevant, written information’’ 

relating to the following: 

1. The existence of evidence ‘‘that 

there is not a preponderance of the 

evidence that the illness, disability, 

injury, condition, or death described in 

the petition is due to factors unrelated 

to the administration of the vaccine 

described in the petition,’’ and 

2. Any allegation in a petition that the 

petitioner either: 

a. ‘‘[S]ustained, or had significantly 

aggravated, any illness, disability, 

injury, or condition not set forth in the 

Vaccine Injury Table but which was 

caused by’’ one of the vaccines referred 

to in the Table, or 

b. ‘‘[S]ustained, or had significantly 

aggravated, any illness, disability, 

injury, or condition set forth in the 

Vaccine Injury Table the first symptom 

or manifestation of the onset or 

significant aggravation of which did not 

occur within the time period set forth in 

the Table but which was caused by a 

vaccine’’ referred to in the Table. 

In accordance with Section 

2112(b)(2), all interested persons may 

submit written information relevant to 

the issues described above in the case of 

the petitions listed below. Any person 

choosing to do so should file an original 

and three (3) copies of the information 

with the Clerk of the United States 

Court of Federal Claims at the address 

listed above (under the heading ‘‘For 

Further Information Contact’’), with a 

copy to HRSA addressed to Director, 

Division of Injury Compensation 

Programs, Healthcare Systems Bureau, 

5600 Fishers Lane, 08N146B, Rockville, 

Maryland 20857. The Court’s caption 

(Petitioner’s Name v. Secretary of HHS) 

and the docket number assigned to the 

petition should be used as the caption 

for the written submission. Chapter 35 

of title 44, United States Code, related 

to paperwork reduction, does not apply 

to information required for purposes of 

carrying out the Program. 

Diana Espinosa, 

Acting Administrator. 

List of Petitions Filed 

1. Hussam Ismael, Orlando, Florida, Court of 

Federal Claims No: 21–1642V 

2. Nicholas D. Goettl, Cincinnati, Ohio, Court 

of Federal Claims No: 21–1644V 

3. Robert Anderson, Vestavia Hills, Alabama, 

Court of Federal Claims No: 21–1645V