42728 Federal Register / Vol. 87, No. 136 / Monday, July 18, 2022 / Notices 

Estimated Total Annual Burden 

Hours: 1,920. 

Authority: 8 U.S.C 1522 of the 

Immigration and Nationality Act (the 

Act) (Title IV, Sec. 412 of the Act), and 

45 CFR 400.28(b). 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–15227 Filed 7–15–22; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–1999–D–2955 (formerly 

1999D–4071)] 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products; 

Impurities: Residual Solvents in New 

Veterinary Medicinal Products, Active 

Substances and Excipients (Revision 

2); Draft Guidance for Industry; 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 (GFI) #100 (VICH 

GL 18(R2)) entitled ‘‘Impurities: 

Residual Solvents in New Veterinary 

Medicinal Products, Active Substances 

and Excipients (Revision 2).’’ This draft 

guidance has been developed for 

veterinary use by the International 

Cooperation on Harmonisation of 

Technical Requirements for Registration 

of Veterinary Medicinal Products 

(VICH). 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. This 

revision updates the listings and 

classification of solvents. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 16, 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this draft guidance before it begins work 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 

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– 

1999–D–2955 (formerly 1999D–4071) 

for ‘‘Impurities: Residual Solvents in 

New Veterinary Medicinal Products, 

Active Substances and Excipients 

(Revision 2).’’ 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 this draft guidance to the 

Policy and Regulations Staff (HFV–6), 

Center for Veterinary Medicine, 7500 

Standish Pl., Rockville, MD 20855. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request or include a fax number to 

which the draft guidance may be sent. 

See the SUPPLEMENTARY INFORMATION

section for information on electronic 

access to the draft guidance. 

FOR FURTHER INFORMATION CONTACT: Mai 

Huynh, Center for Veterinary Medicine 

(HFV–140), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0669, 

mai.huynh@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft GFI #100 (VICH GL18(R2)) 

entitled ‘‘Impurities: Residual Solvents 

in New Veterinary Medicinal Products, 

Active Substances and Excipients 

(Revision 2).’’ Residual solvents in 

pharmaceuticals are defined in the 

guidance as organic volatile chemicals 

that are used or produced in the 

manufacture of active substances or 


khammond on DSKJM1Z7X2PROD with NOTICES
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