1506 Federal Register / Vol. 80, No. 7 / Monday, January 12, 2015 / Notices 

response rate of approximately 60 

percent; thus, we will need to attempt 

to recruit 627 managers/establishments 

via telephone in order to meet our goal 

of 376 establishments. Each manager 

will respond to the recruiting script 

only once for approximately 3 minutes. 

Thus, the maximum burden for the 

manager recruiting attempts will be 

31.35 hours (627 managers × 3 minutes). 

We will collect interview/survey data 

from a manager in each establishment. 

Each manager will respond only once 

for approximately 30 minutes. Thus, the 

maximum burden for the manager 

interview/survey will be 188 hours (376 

managers × 30 minutes). In total, the 

average burden for managers will be 

219.35 hours (31.35 hours for recruiting 

plus 188 hours for the interview/

survey). 

For each data collection, we will 

recruit a worker from each participating 

establishment to provide interview/

survey data. Each worker will respond 

to the recruiting script only once for 

approximately 3 minutes. Thus, the 

maximum burden for the worker 

recruiting attempts will be 18.8 hours 

(376 workers × 3 minutes). We expect a 

worker response rate of 90 percent (339 

workers). Each worker will respond 

only once for approximately 10 minutes. 

Thus, the maximum burden for the 

worker interview/survey will be 56.5 

hours (339 workers × 10 minutes). In 

total, the average burden per worker 

response will be 75.3 hours (18.8 hours 

for recruiting + 56.5 hours for the 

interview/survey). 

There is no cost to respondents other 

than their time. The total estimated 

annual burden for the data collection 

will be 295 hours. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Retail managers ............ Manager Telephone Recruiting Script ................. 627 1 3/60 31 

Retail managers ............ Manager Interview/survey ................................... 376 1 30/60 188 

Retail food workers ........ Worker Recruiting Script ..................................... 376 1 3/60 19 

Retail food workers ........ Worker Interview/survey ...................................... 339 1 10/60 57 

Total ........................ ......................................................................... 295 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–00241 Filed 1–9–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0543] 

Agency Information Collection 

Activities; Proposed Collection; 

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 an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the current burden hours on regulated 

industry of complying with the 

guidance underlying this collection of 

information. 

DATES: Submit electronic or written 

comments on the collection of 

information by March 13, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

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: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 7 / Monday, January 12, 2015 / Notices 1507 

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 No. 0910–0575)—Extension 

In the Federal Register of February 

17, 2006 (79 FR 8596), FDA’s Center for 

Veterinary Medicine issued a guidance 

entitled ‘‘Guidance for Industry # 171, 

Waivers of In Vivo Demonstration of 

Bioequivalence of Animal Drugs in 

Soluble Powder Oral Dosage Form 

Products and Type A Medicated 

Articles’’ 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 

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 shown in tables 1 and 

2 of this document. The source of the 

data is records of generic drug 

applications over the past 10 years. 

FDA estimates the burden of this 

collection of information as follows: 

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

No. of 

respondents 

No. 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

No. of 

respondents 

No. 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 .............................................................................. ........................ ........................ ........................ ........................ 210 

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

Dated: January 6, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–00207 Filed 1–9–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0505] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Reporting and Recordkeeping 

Requirements for Human Food and 

Cosmetics Manufactured From, 

Processed With, or Otherwise 

Containing, Material From Cattle 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Reporting and Recordkeeping 

Requirements for Human Food and 

Cosmetics Manufactured From, 

Processed With, or Otherwise 

Containing, Material From Cattle’’ has 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 


tkelley on DSK3SPTVN1PROD with NOTICES