Federal Register / Vol. 87, No. 136 / Monday, July 18, 2022 / Notices 42729 

excipients, or in the preparation of 

veterinary medicinal products. The 

solvents are not completely removed by 

practical manufacturing techniques. The 

objective of this draft guidance is to 

recommend acceptable amounts for 

residual solvents in pharmaceuticals for 

the safety of the target animal as well as 

for the safety of residues in products 

derived from treated food-producing 

animals. The draft guidance 

recommends use of less toxic solvents 

and describes levels considered to be 

toxicologically acceptable for some 

residual solvents. This revision updates 

the listings and classification of 

solvents. 

FDA has participated in efforts to 

enhance harmonization and is 

committed to seeking scientifically 

based harmonized technical procedures 

for pharmaceutical development. One of 

the goals of harmonization is to identify, 

and then reduce, differences in 

technical requirements for drug 

development among regulatory agencies 

in different countries. 

FDA has actively participated in the 

International Conference on 

Harmonization of Technical 

Requirements for Approval of 

Pharmaceuticals for Human Use to 

develop harmonized technical 

requirements for the approval of human 

pharmaceutical and biological products 

among the European Union, Japan, and 

the United States. The VICH is a parallel 

initiative for veterinary medicinal 

products. The VICH is concerned with 

developing harmonized technical 

requirements for the approval of 

veterinary medicinal products in the 

European Union, Japan, and the United 

States, and includes input from both 

regulatory and industry representatives. 

The VICH Steering Committee is 

composed of member representatives 

from the European Commission and 

European Medicines Agency; 

International Federation for Animal 

Health—Europe; FDA—Center for 

Veterinary Medicine and U.S. 

Department of Agriculture—Center for 

Veterinary Biologics; the U.S. Animal 

Health Institute; the Japanese Veterinary 

Products Association, and the Japanese 

Ministry of Agriculture, Forestry, and 

Fisheries. 

There are eight observers to the VICH 

Steering Committee: One representative 

from government and one representative 

from industry of Australia, New 

Zealand, Canada, and South Africa. The 

World Organisation for Animal Health 

is an associate member of the VICH. The 

VICH Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Animal Health. 

This 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 ‘‘Impurities: Residual Solvents in 

New Veterinary Medicinal Products, 

Active Substances and Excipients 

(Revision 2).’’ 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 draft 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 section 512(n)(1) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b(n)(1)) have been 

approved under OMB control number 

0910–0669; the collections of 

information in 21 CFR part 514 have 

been approved under OMB control 

number 0910–0032. 

III. Electronic Access 

Persons with access to the internet 

may obtain an electronic version of the 

draft guidance at https://www.fda.gov/ 

animal-veterinary/guidance-regulations/ 

guidance-industry, https://www.fda.gov/ 

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

www.regulations.gov. 

Dated: July 12, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–15244 Filed 7–15–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–1366] 

Data Standards; Requirement Begins 

for the Clinical Data Interchange 

Standards Consortium Versions 1.2 

and 1.3 of the Analysis Data Model 

Implementation Guide 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Center for Biologics Evaluation and 

Research (CBER) and Center for Drug 

Evaluation and Research (CDER) are 

announcing the date that support begins 

for versions 1.2 and 1.3 of the Clinical 

Data Interchange Standards Consortium 

(CDISC) Analysis Data Model 

Implementation Guide (ADaMIG) and 

the date that this version update is 

required in certain submissions. The 

Agency will update the FDA Data 

Standards Catalog (Catalog) to reflect 

these changes. 

DATES: Support for versions 1.2 and 1.3 

of the CDISC ADaMIG begins July 18, 

2022. The requirement for electronic 

submissions to be submitted using 

versions 1.2 and 1.3 of the CDISC 

ADaMIG begins March 15, 2024, for new 

drug applications (NDAs), abbreviated 

new drug applications (ANDAs), certain 

biologics license applications (BLAs), 

and certain investigational new drug 

applications (INDs). 

ADDRESSES: You may submit comments 

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 

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. 


khammond on DSKJM1Z7X2PROD with NOTICES
42730 Federal Register / Vol. 87, No. 136 / Monday, July 18, 2022 / Notices 

• 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–1366 for ‘‘Data Standards; 

Requirement Begins for the Clinical 

Data Interchange Standards Consortium 

Versions 1.2 and 1.3 of the Analysis 

Data Model Implementation Guide.’’ 

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. 

FOR FURTHER INFORMATION CONTACT: 

CDER: Helena Sviglin, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1117, 

Silver Spring, MD 20993–0002, 240– 

402–6511, cderdatastandards@

fda.hhs.gov. 

CBER: Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: FDA’s 

CBER and CDER are issuing this Federal 

Register notice to announce the date 

that support begins for versions 1.2 and 

1.3 of the CDISC ADaMIG and the date 

that this version update is required in 

certain submissions. The FDA guidance 

for industry ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Standardized Study Data’’ (June 2021) 

(eStudy Data guidance), posted on 

FDA’s Study Data Standards Resources 

web page at https://www.fda.gov/ 

forindustry/datastandards/studydata

standards/default.htm, implements the 

electronic submission requirements of 

section 745A(a) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

379k–1(a)) for study data contained in 

NDAs, ANDAs, certain BLAs, and 

certain INDs submitted to CDER or 

CBER by specifying the format for 

electronic submissions. The eStudy Data 

guidance states that a Federal Register 

notice will specify any new standards 

and version updates to FDA-supported 

study data standards that will be added 

to the Catalog, when the support for 

such standards and version updates 

begins or ends, and when the 

requirement to use such standards and 

version updates in submissions begins 

or ends. 

Support for versions 1.2 and 1.3 of the 

CDISC ADaMIG begins July 18, 2022. 

The transition date for this version 

update is March 15, 2023. The 

requirement for electronic submissions 

to be submitted using versions 1.2 and 

1.3 of the CDISC ADaMIG is March 15, 

2024, for NDAs, ANDAs, certain BLAs, 

and certain INDs. 

Dated: July 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–15248 Filed 7–15–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier OS–0990–0476] 

Agency Information Collection 

Request; 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. This 

Federal Register notice seeks public 

comment on the revision recently 

submitted to OMB for review and 

approval. These comments will be 

reviewed and taken into consideration if 

the Department intends to make any 

revisions to the information collection 

request approved under [0990–0476]. 

Interested persons are invited to submit 

comments regarding the aforementioned 

non-substantive changes or any other 

aspect of this collection of information, 

including: the necessity and utility of 

the proposed information collection for 

the proper performance of the agency’s 

functions, the accuracy of the estimated 

burden, ways to enhance the quality, 

utility and clarity of the information to 

be collected, and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments on the ICR must be 

received on or before August 17, 2022. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice. To be assured consideration, 

comments and recommendations must 

be submitted www.reginfo.gov/public/ 

do/PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: 

Sherrette Funn, Sherrette.Funn@hhs.gov 

or (202) 264–0041. When submitting 

comments or requesting information, 

please include the document identifier 

0990–0476–30D and project title for 

reference. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 


khammond on DSKJM1Z7X2PROD with NOTICES