Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Notices 15435 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

hours 

Monthly surveys ............................... 10,000 12 15/60 30,000 

Final surveys .................................... 10,000 1 30/60 5,000 

Daily surveys .................................... 10,000 60 10/60 50,000 

Stakeholders of local entities affected by TBDs.Stakeholder Survey .......................... 1,000 1 30/60 500 

Total ........................................... ........................................................... ........................ ........................ ........................ 98,830 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2022–05753 Filed 3–17–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0297] 

Draft Pharmaceutical Quality/ 

Chemistry Manufacturing and Controls 

Data Exchange; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

requesting comment on the draft 

Pharmaceutical Quality/Chemistry 

Manufacturing and Controls (PQ/CMC) 

Data Exchange for the electronic 

submission of PQ/CMC data. This 

document provides draft design of 

Health Level 7 (HL7) Fast Health 

Interoperability Resources (FHIR) 

profiles that contain the data elements 

and terminologies associated with PQ/ 

CMC subject areas and scoped to some 

of what is currently submitted in 

Module 3 of the electronic Common 

Technical Document (eCTD) 

submission. It is not intended to be 

comprehensive in covering all eCTD 

product quality information, only those 

concepts that were considered amenable 

to structuring and would bring value to 

the quality review process. The Agency 

is seeking comment on the mapping of 

the PQ/CMC data elements to the 

various FHIR Resources. This document 

should not be viewed as guidance, 

technical specification, or an 

implementation guide, as it is meant 

solely for comment. The FHIR mapping 

presented in this document is bound to 

the HL7 FHIR R5 draft release. As such, 

it is likely that some parts of the 

mapping presented in this document 

may change based on comments during 

the HL7 balloting and reconciliation 

process. However, since HL7 balloting 

has variable and extensive timelines, the 

Agency determined that it would be 

prudent to provide an early opportunity 

for comment that will inform final 

development of the exchange standard. 

DATES: Submit either electronic or 

written comments 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 

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– 

2022–N–0297 for ‘‘Draft Pharmaceutical 

Quality/Chemistry Manufacturing and 

Controls (PQ/CMC) Data Exchange for 

the electronic submission of PQ/CMC 

data; Request for Comments.’’ 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 


jspears on DSK121TN23PROD with NOTICES1
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 


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