Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Notices 10979 

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; the collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014; the collections of 

information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338; and the collections 

of information in 21 CFR parts 210 and 

211 have been approved under OMB 

control number 0910–0139. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https:// 

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

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

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, https://www.fda.gov/ 

emergency-preparedness-and-response/ 

coronavirus-disease-2019-covid-19/ 

covid-19-related-guidance-documentsindustry-fda-staff-and-otherstakeholders, or https://

www.regulations.gov. 

Dated: February 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03548 Filed 2–22–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–2635] 

Potential Approach for Defining 

Durations of Use for Medically 

Important Antimicrobial Drugs 

Intended for Use In or On Feed: A 

Concept Paper; Request for 

Comments; Extension of Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments; 

extension of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or Agency) is 

extending the comment period for the 

notice that appeared in the Federal 

Register of January 11, 2021. In that 

notice, FDA requested comments 

regarding a document entitled 

‘‘Potential Approach for Defining 

Durations of Use for Medically 

Important Antimicrobial Drugs Intended 

for Use In or On Feed: A Concept 

Paper.’’ The Agency is taking this action 

in response to requests for an extension 

to allow interested persons additional 

time to submit comments. 

DATES: FDA is extending the comment 

period announced in the notice 

published January 11, 2021 (86 FR 

1979). Submit either electronic or 

written comments by June 11, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before June 11, 2021. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of June 11, 2021. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2016–D–2635 for ‘‘Potential Approach 

for Defining Durations of Use for 

Medically Important Antimicrobial 

Drugs Intended for Use In or On Feed: 

A Concept Paper.’’ Received comments 

will be placed in the docket and, except 

for those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

10980 Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Notices 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: John 

Mussman, Center for Veterinary 

Medicine (HFV–133), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0589, 

john.mussman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of January 11, 2021, 

FDA published a notice of availability of 

a document entitled ‘‘Potential 

Approach for Defining Durations of Use 

for Medically Important Antimicrobial 

Drugs Intended for Use In or On Feed: 

A Concept Paper’’ with a 90-day 

comment period. 

Interested persons were originally 

given until April 12, 2021, to comment 

on the concept paper. The Agency has 

received requests to allow interested 

persons additional time to comment. 

The requests conveyed concern that the 

current 90-day comment period does 

not allow sufficient time to develop a 

comprehensive response. We have 

concluded that it is reasonable to extend 

the comment period for 60 days. The 

Agency believes that this extension 

allows adequate time for interested 

persons to submit comments. 

Dated: February 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03532 Filed 2–22–21; 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 

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 

January 1, 2021, through January 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. Sheri Esters, Coeur d’Alene, Idaho, Court 

of Federal Claims No: 21–0001V 

2. Jacob Schriner, Wellesley Hills, California, 

Court of Federal Claims No: 21–0002V 

3. Jade Bunnell, Virginia Beach, Virginia, 

Court of Federal Claims No: 21–0003V