Federal Register / Vol. 87, No. 76 / Wednesday, April 20, 2022 / Notices 23523 

Passcode: N5v5y* 

FOR FURTHER INFORMATION CONTACT: 

Donna Mendrick, National Center for 

Toxicological Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 2208, Silver Spring, 

MD 20993–0002, 301–796–8892, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s website at https://

www.fda.gov/AdvisoryCommittees/

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: On May 18, 2022, the 

Science Advisory Board Chair will 

welcome the participants, and the NCTR 

Director will provide a Center-wide 

update on scientific initiatives and 

accomplishments during the past year. 

The Science Advisory Board will be 

presented with an overview of the 

Science Advisory Board Subcommittee 

Site Visit Report and a response to this 

review. The Center for Biologics 

Evaluation and Research, Center for 

Drug Evaluation and Research, Center 

for Devices and Radiological Health, 

Center for Food Safety and Applied 

Nutrition, Center for Tobacco Products, 

and the Office of Regulatory Affairs will 

each briefly discuss their specific 

research strategic needs and potential 

areas of collaboration. 

On May 19, 2022, there will be 

updates from the NCTR Research 

Divisions and a public comment 

session. Following an open discussion 

of all the information presented, the 

open session of the meeting will close 

so the Science Advisory Board members 

can discuss personnel issues at NCTR. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s website after 

the meeting. Background material is 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: On May 18, 2022, from 8 

a.m. to 5:55 p.m., Central Standard 

Time, and May 19, 2022, from 8 a.m. to 

11:30 a.m., Central Standard Time, the 

meeting is open to the public. Interested 

persons may present data, information, 

or views, orally or in writing, on issues 

pending before the committee. Written 

submissions may be made to the contact 

person on or before May 13, 2022. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Central Standard Time. 

Those individuals interested in making 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before May 5, 2022. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by May 6, 2022. 

Closed Committee Deliberations: On 

May 19, 2022, from 11:30 a.m. to 12 

p.m., Central Standard Time, the 

meeting will be closed to permit 

discussion where disclosure would 

constitute a clearly unwarranted 

invasion of personal privacy (5 U.S.C. 

552b(c)(6)). This portion of the meeting 

will be closed to permit discussion of 

information concerning individuals 

associated with the research programs at 

NCTR. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Donna 

Mendrick at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: April 15, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08460 Filed 4–19–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–1155] 

The Use of Published Literature in 

Support of New Animal Drug 

Applications; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry #106 entitled 

‘‘The Use of Published Literature in 

Support of New Animal Drug 

Applications.’’ This draft guidance, 

when finalized, will replace the existing 

final guidance #106, ‘‘The Use of 

Published Literature in Support of New 

Animal Drug Approval,’’ which FDA 

published in August 2000 and which 

specifically addressed the use of a single 

article to support drug approval. This 

revision of the guidance document 

considers multiple uses of the scientific 

literature, including narrative reviews, 

systematic reviews, and meta-analyses 

to support approval of a new animal 

drug. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by June 21, 2022 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
23524 Federal Register / Vol. 87, No. 76 / Wednesday, April 20, 2022 / Notices 

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– 

2021–D–1155 for ‘‘The Use of Published 

Literature in Support of New Animal 

Drug Applications.’’ 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 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Policy and 

Regulations Staff (HFV–6), Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Amey Adams, Center for Veterinary 

Medicine (HFV–126), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0816, 

Amey.Adams@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry #106 

entitled ‘‘The Use of Published 

Literature in Support of New Animal 

Drug Applications.’’ The purpose of this 

document is to provide guidance to 

animal drug sponsors on specific areas 

of the approval process where the 

available scientific literature may be 

useful to support the approval of a new 

animal drug application, an abbreviated 

new animal drug application, or a 

conditionally approved new animal 

drug application, as well as 

methodologies to ensure the validity of 

conclusions drawn by animal drug 

sponsors from the scientific literature to 

support an approval. 

The original guidance #106, ‘‘The Use 

of Published Literature in Support of 

New Animal Drug Approval,’’ was 

published in 2000 and specifically 

addressed the use of a single article to 

support drug approval. Since its 

publication, animal drug sponsors have 

used literature to support various 

aspects of animal drug development and 

approval, including early stages of drug 

development, dosage characterization, 

microbial food safety, design of the 

target animal safety evaluation, 

prediction of potential adverse effects, 

and substantial evidence of 

effectiveness. 

Animal drug sponsors have expressed 

interest in further leveraging 

information published in the scientific 

literature to support new animal drug 

approvals. Use of published scientific 

literature is of interest because it makes 

use of existing knowledge and may 

reduce the number of animals needed 

for studies to support approval and, in 

some cases, may provide greater 

inferential value compared to individual 

studies conducted for the purpose of 

supporting an approval. Scientific 

literature may also be used to respond 

to specific regulatory questions, identify 

data gaps, and inform protocol design. 

This draft guidance expands upon the 

original guidance #106 by considering 

multiple uses of the scientific literature, 

including narrative reviews, systematic 

reviews, and meta-analyses to support 

approval of a new animal drug. 

This level 1 draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the current 

thinking of FDA on ‘‘The Use of 

Published Literature in Support of New 

Animal Drug Applications.’’ 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 FDA’s guidance entitled 

‘‘The Use of Published Literature in 

Support of New Animal Drug 

Applications’’ have been approved 

under OMB control number 0910–0032. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 76 / Wednesday, April 20, 2022 / Notices 23525 

https://www.fda.gov/animal-veterinary/ 

guidance-regulations/guidanceindustry, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: April 15, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08452 Filed 4–19–22; 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 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 

March 1, 2022, through March 31, 2022. 

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, Health 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. 

Carole Johnson, 

Administrator. 

List of Petitions Filed 

1. Maxwell Manley, Phoenix, Arizona, Court 

of Federal Claims No: 22–0227V 

2. Brendan Bixel, Portland, Oregon, Court of 

Federal Claims No: 22–0228V 

3. Nancy Purcell, Tinley Park, Illinois, Court 

of Federal Claims No: 22–0231V 

4. William Watkins, Norman, Oklahoma, 

Court of Federal Claims No: 22–0232V 

5. Robert Thomson, Woods Cross, Utah, 

Court of Federal Claims No: 22–0234V 

6. Maise Johnson, Springfield, Massachusetts, 

Court of Federal Claims No: 22–0235V 

7. Danae Denton, Chicago, Illinois, Court of 

Federal Claims No: 22–0238V 

8. Khair M. Issa, Woodbridge, Virginia, Court 

of Federal Claims No: 22–0240V 

9. Danielle Poore, Palo Alto, California, Court 

of Federal Claims No: 22–0241V 

10. Margaret Chalgren, Minneapolis, 

Minnesota, Court of Federal Claims No: 

22–0245V 

11. Meredith Perry on behalf of L. P., 

Phoenix, Arizona, Court of Federal 

Claims No: 22–0246V 

12. Teresa Donovan, Seattle, Washington, 

Court of Federal Claims No: 22–0249V 

13. Dana Bertucci on behalf of D. A., Chicago, 

Illinois, Court of Federal Claims No: 22– 

0250V 

14. Marivic Malolos, Fontana, California, 

Court of Federal Claims No: 22–0251V 

15. Jennifer Goldson and Brian Goldson on 

behalf of J. G., Phoenix, Arizona, Court 

of Federal Claims No: 22–0254V 

16. Paul E. Saliba, Dallastown, Pennsylvania, 

Court of Federal Claims No: 22–0257V 

17. Myrtle Barrett, Kershaw, South Carolina, 

Court of Federal Claims No: 22–0258V 

18. Stanley Hatch, Goleta, Florida, Court of 

Federal Claims No: 22–0260V 


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