Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices 20229 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0543] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Waiver of In Vivo 

Demonstration of Bioequivalence of 

Animal Drugs in Soluble Powder Oral 

Dosage Form Products and Type A 

Medicated Articles 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by May 15, 

2015. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0575. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002 PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Waiver of In Vivo Demonstration of 

Bioequivalence of Animal Drugs in 

Soluble Powder Oral Dosage Form 

Products and Type A Medicated 

Articles—21 CFR 514.1(b)(7–8) (OMB 

Control Number 0910–0575)—Extension 

The Center for Veterinary Medicine 

(CVM) issued guidance for industry 

(GFI) #171 entitled ‘‘Waivers of In Vivo 

Demonstration of Bioequivalence of 

Animal Drugs in Soluble Powder Oral 

Dosage Form Products and Type A 

Medicated Articles’’ to describe the 

procedures that the Agency 

recommends for the review of requests 

for waiver of in vivo demonstration of 

bioequivalence for generic soluble 

powder oral dosage form products and 

Type A medicated articles. 

The Generic Animal Drug and Patent 

Term Registration Act (GADPTRA) of 

1988 (Pub. L. 100–670) permitted 

generic animal drug manufacturers to 

copy those pioneer animal drug 

products that were no longer subject to 

patent or other marketing exclusivity 

protection. The approval for marketing 

these generic products is based, in part, 

upon a demonstration of bioequivalence 

between the generic product and 

pioneer product. This guidance clarifies 

circumstances under which FDA 

believes the demonstration of 

bioequivalence required by the statute 

does not need to be established on the 

basis of in vivo studies for soluble 

powder oral dosage form products and 

Type A medicated articles. The data 

submitted in support of the waiver 

request are necessary to validate the 

waiver decision. The requirement to 

establish bioequivalence through in vivo 

studies (blood level bioequivalence or 

clinical endpoint bioequivalence) may 

be waived for soluble powder oral 

dosage form products or Type A 

medicated articles in either of two 

alternative ways. A biowaiver may be 

granted if it can be shown that the 

generic soluble powder oral dosage form 

product or Type A medicated article 

contains the same active and inactive 

ingredient(s) and is produced using the 

same manufacturing processes as the 

approved comparator product or article. 

Alternatively, a biowaiver may be 

granted without direct comparison to 

the pioneer product’s formulation and 

manufacturing process if it can be 

shown that the active pharmaceutical 

ingredient(s) (API) is the same as the 

pioneer product, is soluble, and that 

there are no ingredients in the 

formulation likely to cause adverse 

pharmacologic effects. For the purpose 

of evaluating soluble powder oral 

dosage form products and Type A 

medicated articles, solubility can be 

demonstrated in one of two ways: ‘‘USP 

definition’’ approach or ‘‘Dosage 

adjusted’’ approach. The respondents 

for this collection of information are 

pharmaceutical companies 

manufacturing animal drugs. FDA 

estimates the burden for this collection 

of information as follows in Tables 1 

and 2 of this document. The source of 

the above data is records of generic drug 

applications over the past 10 years. 

In the Federal Register of January 12, 

2015 (80 FR 1506), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. One comment was 

received, however it did not respond to 

any of the four information collection 

topics solicited and is therefore not 

addressed by the Agency. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR WATER SOLUBLE POWDERS 1

CVM Guidance for industry #171 Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Same formulation/manufacturing process approach ........... 1 1 1 5 5 

Same API/solubility approach .............................................. 5 5 5 10 50 

Total .............................................................................. ........................ ........................ ........................ ........................ 55 

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

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR TYPE A MEDICATED ARTICLES 1

CVM Guidance for industry #171 Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Same formulation/manufacturing process approach ........... 2 2 2 5 10 


tkelley on DSK3SPTVN1PROD with NOTICES
20230 Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR TYPE A MEDICATED ARTICLES 1—Continued 

CVM Guidance for industry #171 Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Same API/solubility approach .............................................. 10 10 10 20 200 

Total .............................................................................. ........................ ........................ ........................ ........................ 210 

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

Dated: April 8, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08635 Filed 4–14–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–2347] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Food and 

Cosmetic Export Certificate 

Application Process 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by May 15, 

2015. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–NEW and 

title ‘‘Food and Cosmetic Export 

Certificate Application Process (21 

U.S.C. 381(e)).’’ Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Road; COLE–14526, Silver 

Spring, MD 20993–0002 PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Food and Cosmetic Export Certificate 

Application Process (21 U.S.C. 381(e)) 

(OMB Control Number 0910–NEW) 

Some foreign countries require 

manufacturers of FDA-regulated 

products to provide an export certificate 

for the products they wish to export to 

that country. A Certificate of Free Sale 

is a certificate (not pertaining to a 

particular production lot or export 

consignment) that indicates that the 

particular product is marketed in the 

United States or eligible for export, and 

that the particular manufacturer has no 

unresolved enforcement actions 

pending before or taken by FDA. FDA’s 

Center for Food Safety and Applied 

Nutrition (CFSAN) issues such 

certificates for food, food additives, 

seafood, dietary supplements, and 

cosmetics. Interested persons may 

request a certificate by using the 

electronic CFSAN Certificate 

Application Process, which is part of 

FDA Unified Registration and Listing 

System, or by submitting a paper Form 

FDA 3613d for cosmetic products or a 

paper Form FDA 3613e for food 

products. We use the information 

submitted to determine whether to issue 

the requested certificate. 

OMB has approved the submission of 

requests for export certificates on paper 

Forms FDA 3613d and FDA 3613e and, 

electronically, via the CFSAN Certificate 

Application Process under OMB control 

number 0910–0498. This notice 

announces that, to ensure the efficient 

review of the information collection by 

OMB under the PRA, we are seeking to 

obtain a new OMB Control Number for 

Forms FDA 3613d and FDA 3613e and 

the CFSAN Certificate Application 

Process to reflect that the electronic 

submission system for food and 

cosmetic export certificates is separate 

from the electronic submission system 

associated with export certificates for 

other FDA-regulated products approved 

under OMB control number 0910–0498. 

Upon OMB approval of this information 

collection request, we will adjust the 

burden hours associated with Forms 

FDA 3613d and FDA 3613e and the 

CFSAN Certificate Application Process 

approved under OMB control number 

0910–0498. 

We request the following information 

on Form FDA 3613d and the CFSAN 

Certificate Application Process, as 

currently approved by OMB: The name 

of and contact information for the 

requester; the name of and contact 

information for the exporting company 

(if different from requester); a 

designation of the type of certificate 

requested (‘‘general’’ or ‘‘productspecific’’); if product-specific, a list of 

the exact brand names of the products; 

the contact person, company name and 

address where the requested certificate 

should be sent; and, the name and 

account number (if applicable) of the 

requester’s preferred carrier for delivery 

of the certificate. Finally, Form FDA 

3613d and the CFSAN Certificate 

Application Process requires the 

requester’s signature, the name and title 

of the person signing the form, as well 

as the date signed. 

We request the following information 

on Form FDA 3613e and the CFSAN 

Certificate Application Process, as 

currently approved by OMB: The name 

of and contact information for the 

manufacturer, as well as the 

manufacturer’s state license or 

registration number; the name of and 

contact information for the exporting 

company (if different from 

manufacturer), as well as the exporting 

company’s state license or registration 

number; a description of the shipment 

including the product, the common 

name, the manufacturer, and a 

description or additional comments; the 

name of the country to which the 

requester of the certificate intends to 

ship the product; the contact person, 

firm name and address where the 

requested certificate should be sent; 

and, the name and account number (if 

applicable) of the requester’s preferred 

carrier for delivery of the certificate. 

Form FDA 3613e and the CFSAN 

Certificate Application Process requires 

the requestor to submit an original or 

copy of the applicable product label or 

labels. Finally, Form FDA 3613e and the 

CFSAN Certificate Application Process 


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