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
1508 Federal Register / Vol. 80, No. 7 / Monday, January 12, 2015 / Notices 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

September 30, 2014, the Agency 

submitted a proposed collection of 

information entitled ‘‘Reporting and 

Recordkeeping Requirements for Human 

Food and Cosmetics Manufactured 

From, Processed With, or Otherwise 

Containing, Material From Cattle’’ to 

OMB for review and clearance under 44 

U.S.C. 3507. An Agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

OMB has now approved the information 

collection and has assigned OMB 

control number 0910–0623. The 

approval expires on November 30, 2017. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http://

www.reginfo.gov/public/do/PRAMain. 

Dated: January 6, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–00204 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–2014–D–0092] 

Study Data Technical Conformance 

Guide and Data Standards Catalog; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a Study Data Technical 

Conformance Guide, Version 2.0 

(Guide), and an update to the Data 

Standards Catalog (Catalog). The Guide 

supplements the final guidance for 

industry entitled ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Standardized Study Data’’ (eStudy Data 

guidance) and provides specifications 

and recommendations for, as well as 

general considerations on, submitting 

standardized study data using FDAsupported data standards specified in 

the Catalog. The Guide is intended to 

complement and promote interactions 

between sponsors and FDA review 

divisions. 

DATES: Submit either electronic or 

written comments on these documents 

at any time. 

ADDRESSES: Submit written requests for 

a copy of the Study Data Technical 

Conformance Guide and the Data 

Standards Catalog to the Division of 

Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: Ron 

Fitzmartin, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1192, Silver Spring, 

MD 20993–0002, 301–796–5333, 

ronald.fitzmartin@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

Version 2.0 of the Guide and an update 

to the Catalog. The Guide supplements 

the final guidance for industry entitled 

‘‘Providing Regulatory Submissions in 

Electronic Format—Standardized Study 

Data’’ (available at http://www.fda.gov/

Drugs/GuidanceComplianceRegulatory

Information/Guidances/default.htm), 

and provides technical 

recommendations to sponsors for the 

electronic submission of standardized 

animal and human study data and 

related information contained in certain 

submissions to new drug applications 

(NDAs), abbreviated new drug 

applications (ANDAs), biologic license 

applications (BLAs), and investigational 

new drug applications (INDs). The 

eStudy Data guidance implements the 

electronic submission requirements of 

section 745A(a) of the Federal Food, 

Drug, and Cosmetic Act (which was 

added by section 1136 of the Food and 

Drug Administration Safety and 

Innovation Act (Pub. L. 112–144)) for 

standardized study data contained in 

NDA, ANDA, BLA, and IND 

submissions. 

The Guide is intended to complement 

and promote interactions between 

sponsors and FDA review divisions. It is 

not intended to replace the need for 

sponsors to communicate directly with 

review divisions regarding data 

standards implementation approaches 

or issues. 

The Guide is organized as follows: 

Section 1: ‘‘Introduction’’—provides 

information on regulatory policy and 

guidance background, purpose, and 

document control. 

Section 2: ‘‘Planning and Providing 

Standardized Study Data’’— 

recommends and provides details on 

preparing an overall study data 

standardization plan, a study data 

reviewer’s guide, and an analysis data 

reviewer’s guide. 

Section 3: ‘‘Exchange Format— 

Electronic Submissions’’—presents the 

specifications, considerations, and 

recommendations for the file formats 

currently supported by FDA. 

Section 4: ‘‘Study Data Submission 

Format: Clinical and Nonclinical’’— 

presents general considerations and 

specifications for sponsors using, for 

example, the following standards for the 

submission of study data: Study Data 

Tabulation Model (SDTM), Analysis 

Data Model (ADaM), and Standard for 

Exchange of Nonclinical Data (SEND). 

Section 5: ‘‘Therapeutic Area 

Standards’’—presents supplemental 

considerations and specific 

recommendations when sponsors 

submit study data using FDA-supported 

therapeutic area standards. 

Section 6: ‘‘Terminology’’—presents 

general considerations and specific 

recommendations when using 

controlled terminologies/vocabularies 

for clinical trial data. 

Section 7: ‘‘Electronic Submission 

Format’’—provides specifications and 

recommendations on submitting study 

data using the electronic Common 

Technical Document format. 

Section 8: ‘‘Data Validation and 

Traceability’’—provides general 

recommendations on conformance to 

standards, data validation rules, data 

traceability expectations, and legacy 

data conversion. 

In the Federal Register of February 6, 

2014 (79 FR 7201), FDA announced the 

availability of Version 1.0 of the Study 

Data Technical Conformance Guide. The 

comment period on the Guide ended on 

May 7, 2014. We reviewed all comments 

received and revised it accordingly. 

Updates to Version 2.0 include, but are 

not limited to: 

Section 2: Added a subsection to 

include an Analysis Data Reviewer’s 

Guide. 

Section 3: Clarified dataset sizes, 

column lengths, special characters for 

variables, and datasets. 

Section 4: Clarified general 

considerations and domain 

specifications for SDTM and ADaM. 

Section 6: Clarified a number of 

subsections, including controlled 

terminology, medications, 

pharmacologic class, and indication, 

and added a World Health Organization 

Drug Dictionary. 


tkelley on DSK3SPTVN1PROD with NOTICES