Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 15763 

proceedings). A petition for 

reconsideration must contain a full 

statement in a well-organized format of 

the factual and legal grounds upon 

which the petition relies. The grounds 

must demonstrate that relevant 

information and views contained in the 

administrative record were not 

previously or not adequately considered 

by the Commissioner. The respondent 

must submit a petition no later than 30 

days after the decision involved. 

However, the Commissioner may, for 

good cause, permit a petition to be filed 

after 30 days. An interested person who 

wishes to rely on information or views 

not included in the administrative 

record shall submit them with a new 

petition to modify the decision. FDA 

uses the information provided in the 

request to determine whether to grant 

the petition for reconsideration. 

Respondents to this collection of 

information are individuals of 

households, State or local governments, 

not-for-profit institutions, and 

businesses or other for-profit 

institutions who are requesting from the 

Commissioner a reconsideration of a 

matter. 

Section 10.35 (21 CFR 10.35), issued 

under section 701(a) of the FD&C Act, 

sets forth the format and procedures by 

which an interested person may request, 

in accordance with § 10.20, the 

Commissioner to stay the effective date 

of any administrative action. 

Such a petition must do the following: 

(1) Identify the decision involved; (2) 

state the action requested, including the 

length of time for which a stay is 

requested; and (3) include a statement of 

the factual and legal grounds on which 

the interested person relies in seeking 

the stay. FDA uses the information 

provided in the request to determine 

whether to grant the petition for stay of 

action. 

Respondents to this information 

collection are interested persons who 

choose to file a petition for an 

administrative stay of action. 

Section 10.85 (21 CFR 10.85), issued 

under section 701(a) of the FD&C Act 

sets forth the format and procedures by 

which an interested person may request, 

in accordance with § 10.20, an advisory 

opinion from the Commissioner on a 

matter of general applicability. An 

advisory opinion represents the formal 

position of FDA on a matter of general 

applicability. When making a request, 

the petitioner must provide a concise 

statement of the issues and questions on 

which an opinion is requested, and a 

full statement of the facts and legal 

points relevant to the request. 

Respondents to this collection of 

information are interested persons 

seeking an advisory opinion from the 

Commissioner on the Agency’s formal 

position for matters of general 

applicability. 

In accordance with 5 CFR 1320.8(d), 

FDA published a 60-day notice for 

public comment in the Federal Register 

of September 7, 2011 (76 FR 55396), to 

which the Agency received one 

comment. However, this comment 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 

10.30 .................................................................................... 207 1 207 24 4,968 

10.33 .................................................................................... 4 1 4 10 40 

10.35 .................................................................................... 5 1 5 10 50 

10.85 .................................................................................... 4 1 4 16 64 

Total .............................................................................. ........................ ........................ ........................ ........................ 5,122 

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

The burden estimates for this 

collection of information are based on 

Agency records and experience over the 

past 3 years. In 2010, FDA received 

approximately 207 petitions (§ 10.30), 4 

administrative reconsiderations of 

action (§ 10.33), 5 administrative stays 

of action (§ 10.35), and 4 advisory 

opinions (§ 10.85). 

Dated: March 12, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6392 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–0625] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Filing Objections 

and Requests for a Hearing on a 

Regulation or Order 

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 0910–0184. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

7726, Ila.Mizrachi@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

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

has submitted the following proposed 

mstockstill on DSK4VPTVN1PROD with NOTICES

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