29352 Federal Register / Vol. 75, No. 100 / Tuesday, May 25, 2010 / Notices 

what other interpretations of the term 

‘‘transfer’’ as it is used in section 

417(d)(B)(2) of the act would be more 

appropriate. Specifically, we are 

requesting comment on whether the 

interpretation of the term ‘‘transfer’’ 

should be dependent upon possession 

of the food, whether the interpretation 

should be dependent on ownership of 

the food, or whether there are other 

interpretations we should consider, 

such as a combination of possession 

and/or ownership. 

IV. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at http:// 

www.fda.gov/FoodGuidances or http:// 

www.regulations.gov. 

Dated: May 19, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–12456 Filed 5–24–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0241] 

Draft Guidance for Industry on Data 

Elements for Submission of Veterinary 

Adverse Event Reports to the Center 

for Veterinary Medicine; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry #188 entitled ‘‘Data Elements 

for Submission of Veterinary Adverse 

Event Reports to the Center for 

Veterinary Medicine.’’ The purpose of 

this draft guidance is to assist sponsors 

or non-applicants with filling out form 

FDA 1932, ‘‘Veterinary Adverse Drug 

Reaction, Lack of Effectiveness, Product 

Defect Report,’’ as required by FDA 

regulations. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by August 9, 2010. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 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. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments on the draft guidance to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Lynn Post, Center for Veterinary 

Medicine (HFV–210), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9191, 

email: Lynn.Post@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry #188 

entitled ‘‘Data Elements for Submission 

of Veterinary Adverse Event Reports to 

the Center for Veterinary Medicine.’’ 

The purpose of this draft guidance is to 

assist sponsors or non-applicants with 

filling out Form FDA 1932, in both 

paper and electronic format. Section 

512(l) of the Federal Food, Drug and 

Cosmetic Act (the act) (21 U.S.C. 

360b(l)) and § 514.80(b) (21 CFR 

514.80(b)) require applicants of 

approved new animal drug applications 

(NADAs) and approved abbreviated new 

animal drug applications (ANADAs) to 

report adverse drug experiences and 

product/manufacturing defects. 

This continuous monitoring of 

approved NADAs and ANADAs affords 

the primary means by which FDA 

obtains information regarding potential 

problems with the safety and efficacy of 

marketed approved new animal drugs as 

well as potential product/manufacturing 

problems. Post-approval marketing 

surveillance is important because data 

previously submitted to FDA may no 

longer be adequate, as animal drug 

effects can change over time and less 

apparent effects may take years to 

manifest. An applicant must report 

adverse drug experiences and product/ 

manufacturing defects on Form FDA 

1932, ‘‘Veterinary Adverse Drug 

Reaction, Lack of Effectiveness, Product 

Defect Report.’’ 

II. Significance of Guidance 

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 agency’s 

current thinking on this topic. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

III. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in section 512(l) of the 

act and § 514.80 have been approved 

under OMB Control No. 0910–0645. 

IV. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/AnimalVeterinary/ 

default.htm or http:// 

www.regulations.gov. 

Dated: May 19, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–12454 Filed 5–24–10; 8:45 am] 

BILLING CODE 4160–01–S 


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