15436 Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Notices 

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. 

FOR FURTHER INFORMATION CONTACT: 

Bryan Spells, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1117, Silver Spring, 

MD 20993–0002, Bryan.Spells@

fda.hhs.gov, 240–402–6511; Stephen 

Ripley, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911; Norman Gregory, Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl. 

(HFV–143), Rockville, MD 20855, 

Norman.Gregory@fda.hhs.gov, 240– 

402–0684; or Michael Kerrigan, Center 

for Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl. 

(HFV–143), Rockville, MD 20855, 240– 

402–0644, Michael.Kerrigan@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

PQ/CMC is a term used to describe 

manufacturing and testing data of 

pharmaceutical products. PQ/CMC 

encompasses topics such as drug 

stability, quality specification, batch 

formula, and batch analysis, which are 

important aspects of drug development. 

PQ/CMC plays an integral part in the 

regulatory review process and life cycle 

management of pharmaceutical 

products. The development of a 

structured format for PQ/CMC data will 

enable consistency in the content and 

format of PQ/CMC data submitted, thus 

providing a harmonized language for 

submission content, allowing reviewers 

to query the data, and, in general, 

contributing to a more efficient and 

effective regulatory decision-making 

process by creating a standardized data 

dictionary. 

The impetus for this standardization 

effort was the provisions from the 2012 

Food and Drug Administration Safety 

and Innovation Act (Pub. L. 112–144), 

which authorized the Agency to require 

certain submissions to be submitted in 

a specified electronic format. PQ/CMC 

standardization supports FDA’s 

regulatory needs in receiving structured 

and standardized data in 

pharmaceutical quality and includes 

two objectives: (1) To standardize the 

pharmaceutical quality data that is 

currently received by FDA in eCTD 

Module 3 from the sponsoring 

organizations, and (2) to use these 

structured elements and develop a FHIR 

data exchange solution. 

Through this notice, the Agency is 

seeking comment on the mapping of the 

PQ/CMC data elements to the various 

FHIR Resources. After receiving 

comments, the Agency intends to issue 

guidance on the standardization of PQ/ 

CMC data elements and terminologies 

for electronic submissions. 

II. Electronic Access 

Persons with access to the internet 

may obtain the draft data elements and 

terminologies at either https://

www.fda.gov/industry/fda-resourcesdata-standards or https://

www.regulations.gov. 

Dated: March 15, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05790 Filed 3–17–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–1517] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Abbreviated New 

Animal Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection provisions of abbreviated new 

animal drug applications. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 17, 2022. 

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 May 17, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of May 17, 2022. 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 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Notices 15437 

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– 

2019–N–1517 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Abbreviated New Animal Drug 

Applications.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Showalter, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 240–994–7399, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Abbreviated New Animal Drug 

Applications—Section 512(b)(2) and 

(n)(1) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 360b(b)(2) and 

(n)(1)) 

OMB Control Number 0910–0669— 

Extension 

Under section 512(b)(2) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act), any person may file an abbreviated 

new animal drug application (ANADA) 

seeking approval of a generic copy of an 

approved new animal drug. The 

information required to be submitted as 

part of an ANADA is described in 

section 512(n)(1) of the FD&C Act. 

Among other things, an ANADA is 

required to contain information to show 

that the proposed generic drug is 

bioequivalent to, and has the same 

labeling as, the approved new animal 

drug. We allow applicants to submit a 

complete ANADA or to submit 

information in support of an ANADA 

for phased review. Applicants may 

submit Form FDA 356v with a complete 

ANADA or a phased review submission 

to ensure efficient and accurate 

processing of information. Form FDA 

356v is approved under OMB control 

number 0910–0032. We use the 

information submitted, among other 

things, to assess bioequivalence to the 

originally approved drug and thus, the 

safety and effectiveness of the generic 

new animal drug. 

The information collection also 

includes applicant requests to waive the 

requirement to establish bioequivalence 

through in vivo studies (biowaiver 

requests) for soluble powder oral dosage 

form products or certain Type A 

medicated articles based upon either of 

two methods. We use the information 

submitted by applicants in the 

biowaiver request as the basis for our 

decision whether to grant the request. 

Therefore, the information collection 

references the guidance document GFI 

#171—Demonstrating Bioequivalence 

for Soluble Powder Oral Dosage Form 

Products and Type A Medicated 

Articles Containing Active 

Pharmaceutical Ingredients Considered 

to Be Soluble in Aqueous Media, which 

discusses statutory bioequivalence 

requirements as well as qualifications 

for requesting a waiver from the 

requirements. The guidance can be 

viewed on our website at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/cvmgfi-171-demonstrating-bioequivalencesoluble-powder-oral-dosage-formproducts-and-type-medicated. 

The reporting associated with 

ANADAs and related submissions is 

necessary to ensure that new animal 

drugs are in compliance with section 

512(b)(2) of the FD&C Act. We use the 

information submitted, among other 

things, to assess bioequivalence to the 

originally approved drug and thus, the 

safety and effectiveness of the generic 

new animal drug. 

Description of Respondents: The 

respondents for this collection of 

information are veterinary 

pharmaceutical manufacturers. 

FDA estimates the burden of this 

collection of information as follows: 


jspears on DSK121TN23PROD with NOTICES1
15438 Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity FDA Form No. Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total 

hours 

ANADA .............................................................................................. 356v 20 1 20 159 3,180 

Phased review with administrative ANADA ...................................... 356v 6 5 30 31.8 954 

Biowaiver request for soluble powder oral dosage form product, 

using same formulation/manufacturing process approach ........... N/A 1 1 1 5 5 

Biowaiver request for soluble powder oral dosage form product, 

using same API/solubility approach .............................................. N/A 5 1 5 10 50 

Biowaiver request for Type A medicated article, using same formulation/manufacturing process approach ........................................ N/A 2 1 2 5 10 

Biowaiver request for Type A medicated article, using same API/ 

solubility approach ......................................................................... N/A 5 1 5 20 100 

Total ........................................................................................... ........................ ........................ ........................ 63 ........................ 4,299 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

We base our estimates on our records 

of generic animal drug applications. We 

estimate that we will receive 26 ANADA 

submissions per year over the next 3 

years and that 6 of those submissions 

will request phased review. We estimate 

that each applicant that uses the phased 

review process will have approximately 

five phased reviews per application. We 

estimate that an applicant will take 

approximately 159 hours to prepare 

either an ANADA or the estimated five 

ANADA phased review submissions 

and the administrative ANADA. Our 

estimates of the burden of biowaiver 

requests for generic soluble powder oral 

dosage form products and Type A 

medicated articles differ based on the 

type of product and the basis for the 

request, as shown in table 1. We 

estimate that an applicant will take 

between 5 and 20 hours to prepare a 

biowaiver request. 

Our estimated burden for the 

information collection reflects an 

overall increase of 695 hours and a 

corresponding increase of 12 responses. 

Based on a review of the information 

collection since our last request for 

OMB renewal, the increase in the 

burden hours estimate is attributable to 

an increase in the number of 

respondents submitting generic drug 

applications. 

Dated: March 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05782 Filed 3–17–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; SHIP COVID–19 Testing and 

Mitigation Program Data Collection, 

OMB No. 0906–0066—Extension 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with of the 

Paperwork Reduction Act of 1995, 

HRSA has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30 day 

comment period for this Notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than April 18, 2022. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Samantha Miller, the acting HRSA 

Information Collection Clearance Officer 

at paperwork@hrsa.gov or call (301) 

443–9094. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

SHIP COVID–19 Testing and Mitigation 

Program Data Collection OMB No. 

0906–0066—Extension. 

Abstract: The American Rescue Plan 

Act of 2021 (Pub. L. 117–2) provided 

one-time funding for awards that will be 

carried out under section 711 of the 

Social Security Act (42 U.S.C. 

912(b)(5)). The Small Rural Hospital 

Improvement Program (SHIP) is 

requesting an extension of an 

information collection request. State 

grantees will improve health care in 

rural areas by using the funding to 

provide support to eligible rural 

hospitals to increase COVID–19 testing 

efforts, expand access to testing in rural 

communities, and expand the range of 

mitigation activities. 

A 60-day Notice published in the 

Federal Register, 86 FR 74095 

(December 29, 2021). There were no 

public comments. 

Need and Proposed Use of the 

Information: The terms and conditions 

for this program specify that, ‘‘hospitals 

will be required to report on the number 

of tests provided and categories in 

which the funding is spent.’’ The data 

will allow HRSA to ensure SHIP 

COVID–19 recipients are meeting the 

terms and conditions of their funding, 

while providing HRSA with information 

on the effectiveness of funds distributed 

through this program. 

Likely Respondents: The respondents 

will be hospital staff and designated 

Representatives, and State Office of 

Rural Health Staff. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 


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