15764 Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 

collection of information to OMB for 

review and clearance. 

Filing Objections and Requests for a 

Hearing on a Regulation or Order—21 

CFR Part 12 (OMB Control Number 

0910–0184)—Extension 

The regulations in 21 CFR 12.22, 

issued under section 701(e)(2) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 371(e)(2)), set forth the 

instructions for filing objections and 

requests for a hearing on a regulation or 

order under § 12.20(d) (21 CFR 

12.20(d)). Objections and requests must 

be submitted within the time specified 

in § 12.20(e). Each objection, for which 

a hearing has been requested, must be 

separately numbered and specify the 

provision of the regulation or the 

proposed order. In addition, each 

objection must include a detailed 

description and analysis of the factual 

information and any other document, 

with some exceptions, supporting the 

objection. Failure to include this 

information constitutes a waiver of the 

right to a hearing on that objection. FDA 

uses the description and analysis to 

determine whether a hearing request is 

justified. The description and analysis 

may be used only for the purpose of 

determining whether a hearing has been 

justified under § 12.24 (21 CFR 12.24) 

and do not limit the evidence that may 

be presented if a hearing is granted. 

Respondents to this information 

collection are those parties that may be 

adversely affected by an order or 

regulation. 

In accordance with 5 CFR 1320.8(d), 

FDA published a 60-day notice for 

public comment in the Federal Register 

of September 9, 2011 (76 FR 55922), to 

which the Agency received two 

comments. However, these comments 

did not address the information 

collection. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

12.22 ..................................................................................... 3 1 3 20 60 

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

The burden estimate for this 

collection of information is based on 

past filings. Agency personnel 

responsible for processing the filing of 

objections and requests for a public 

hearing on a specific regulation or order 

estimate approximately three requests 

are received by the Agency annually, 

with each requiring approximately 20 

hours of preparation time. 

Dated: March 12, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6393 Filed 3–15–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0747] 

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 April 16, 

2012. 

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: 

Juanmanuel Vilela, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–7651, 

Juanmanuel.vilela@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) and (b)(8) 

(OMB Control Number 0910–0575)— 

Extension 

The Center for Veterinary Medicine 

has written this guidance to address a 

perceived need for Agency guidance in 

its work with the animal health 

industry. This guidance describes 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 of 1988 (Pub. L. 

100–670) permitted generic drug 

manufacturers to copy those pioneer 

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 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 15765 

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 October 24, 

2011 (76 FR 65733), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received one 

comment, which, however, did not 

address the questions posed in 60-day 

notice regarding the collection of 

information. The comment supported 

the bioequivalence program but 

suggested a revision to the 

determination of bioequivalence, which 

relates to the substance of the scientific 

recommendations in the guidance 

document. Under FDA’s good guidance 

practices regulations (21 CFR 

10.115(f)(4)), the public may suggest at 

anytime that FDA revise a guidance 

document and under 21 CFR 

10.115(g)(5), FDA will revise guidance 

documents in response to comments 

when appropriate. 

FDA estimates the burden of this 

collection of information as follows: 

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

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 burden hours ....................................................... ........................ ........................ ........................ ........................ 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

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 

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

Total burden hours ....................................................... ........................ ........................ ........................ ........................ 210 

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

Dated: March 8, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6391 Filed 3–15–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0451] 

Food and Drug Administration 

Modernization Act of 1997: 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

028 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

publication containing modifications 

the Agency is making to the list of 

standards FDA recognizes for use in 

premarket reviews (FDA recognized 

consensus standards). This publication, 

entitled ‘‘Modifications to the List of 

Recognized Standards, Recognition List 

Number: 028’’ (Recognition List 

Number: 028), will assist manufacturers 

who elect to declare conformity with 

consensus standards to meet certain 

requirements for medical devices. 

DATES: Submit either electronic or 

written comments concerning this 

document at any time. See section VII 

of this document for the effective date 

of the recognition of standards 

announced in this document. 

ADDRESSES: Submit written requests for 

single copies of ‘‘Modifications to the 

List of Recognized Standards, 

Recognition List Number: 028’’ to the 

Division of Small Manufacturers, 

International and Consumer Assistance, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Silver Spring, MD 20993. Send two selfaddressed adhesive labels to assist that 

office in processing your requests, or fax 

your request to 301–847–8149. Submit 

electronic comments concerning this 

document to standards@cdrh.fda.gov. 

Submit written comments concerning 

this document, or recommendations for 

additional standards for recognition, to 

the contact person (see FOR FURTHER

INFORMATION CONTACT). This document 

may also be accessed on FDA’s Internet 

site at http://www.fda.gov/

MedicalDevices/

DeviceRegulationandGuidance/

Standards/ucm123792.htm. See section 

VI of this document for electronic access 

to the searchable database for the 

current list of FDA recognized 

consensus standards, including 

Recognition List Number: 028 

modifications and other standards 

related information. 

FOR FURTHER INFORMATION CONTACT: 

Scott A. Colburn, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

mstockstill on DSK4VPTVN1PROD with NOTICES