9944 Federal Register / Vol. 77, No. 34 / Tuesday, February 21, 2012 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden hours per 

response 

Total burden 

hours 

ACF–196T ........................................................................................................ 51 4 2 408 

ACF–196 .......................................................................................................... 51 4 8 1,632 

Estimated Total Annual Burden 

Hours: 2,040. 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: ACF Reports Clearance Officer. 

Email address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2012–3895 Filed 2–17–12; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–P–0170] 

Determination That REQUIP XL 

(Ropinerole Hydrochloride) ExtendedRelease Tablets, 3 Milligrams, Were 

Not Withdrawn From Sale for Reasons 

of Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that REQUIP XL (ropinerole 

hydrochloride) extended-release tablets, 

3 milligrams (mg), were not withdrawn 

from sale for reasons of safety or 

effectiveness. This determination will 

allow FDA to approve abbreviated new 

drug applications (ANDAs) for 

ropinerole hydrochloride extendedrelease tablets, 3 mg, if all other legal 

and regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: Jay 

Sitlani, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 6370, Silver Spring, 

MD 20993–0002, 301–796–3601. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). The only clinical data required 

in an ANDA are data to show that the 

drug that is the subject of the ANDA is 

bioequivalent to the listed drug. 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (§ 314.162 (21 

CFR 314.162)). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

REQUIP XL (ropinerole 

hydrochloride) extended-release tablets, 

3 mg, are the subject of NDA 22–008, 

held by GlaxoSmithKline, and initially 

approved on June 13, 2008. REQUIP XL 

is indicated for the treatment of 

treatment of signs and symptoms of 

idiopathic Parkinson’s disease. 

REQUIP XL (ropinerole 

hydrochloride) extended-release tablets, 

3 mg, are currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

GlaxoSmithKline has never marketed 

REQUIP XL (ropinerole hydrochloride) 

extended-release tablets, 3 mg. In 

previous instances (see, e.g., 72 FR 

9763, 61 FR 25497), the Agency has 

determined that, for purposes of 

§§ 314.161 and 314.162, never 

marketing an approved drug product is 

equivalent to withdrawing the drug 

from sale. 

Lachman Consultant Services, Inc. 

submitted a citizen petition dated April 

1, 2009 (Docket No. FDA–2009–P– 

0170), under 21 CFR 10.30, requesting 

that the Agency determine whether 

REQUIP XL (ropinerole hydrochloride) 

extended-release tablets, 3 mg, were 

withdrawn from sale for reasons of 

safety or effectiveness. 

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Federal Register / Vol. 77, No. 34 / Tuesday, February 21, 2012 / Notices 9945 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that REQUIP XL (ropinerole 

hydrochloride) extended-release tablets, 

3 mg, were not withdrawn for reasons 

of safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that REQUIP XL 

(ropinerole hydrochloride) extendedrelease tablets, 3 mg, were withdrawn 

for reasons of safety or effectiveness. We 

have carefully reviewed our files for 

records concerning the withdrawal of 

REQUIP XL (ropinerole hydrochloride) 

extended-release tablets, 3 mg, from 

sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events. We have found no information 

that would indicate that this product 

was withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list REQUIP XL (ropinerole 

hydrochloride) extended-release tablets, 

3 mg, in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 

List’’ delineates, among other items, 

drug products that have been 

discontinued from marketing for reasons 

other than safety or effectiveness. 

ANDAs that refer to REQUIP XL 

(ropinerole hydrochloride) extendedrelease tablets, 3 mg, may be approved 

by the Agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: February 14, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–3954 Filed 2–17–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0097] 

Draft Guidance for Industry on 

Providing Submissions in Electronic 

Format—Standardized Study Data; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Providing 

Submissions in Electronic Format— 

Standardized Study Data.’’ This draft 

guidance establishes FDA’s 

recommendation that sponsors and 

applicants submit nonclinical and 

clinical study data in a standardized 

electronic format. The draft guidance 

recognizes that standardized study data 

promotes the efficient review of this 

information. The purpose of this draft 

guidance is to promote the use of data 

standards for study data, and increase 

the number of standardized study data 

submissions to the Center for Drug 

Evaluation and Research, the Center for 

Biologics Evaluation and Research, and 

the Center for Devices and Radiological 

Health. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by April 23, 2012. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 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 or the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. The 

guidance may also be obtained by mail 

by calling CBER at 1–800–835–4709 or 

301–827–1800. Send one self-addressed 

adhesive label to assist that office in 

processing your requests. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

Submit electronic comments on the 

draft 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: Kieu 

Pham, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 21, Rm. 4677, Silver Spring, 

MD 20993–0002, 301–796–1616, or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, Suite 200N, Rockville, 

MD 20852–1448, 301–827–6210, or 

Terrie Reed, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 3324, 

Silver Spring, MD 20993–0002, 301– 

796–6130. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Providing Submissions in Electronic 

Format—Standardized Study Data.’’ 

FDA routinely receives submissions of 

the results of scientific studies, 

including clinical trials and animal 

studies. For many years, FDA has 

requested that clinical study data be 

submitted electronically because paper 

case report tabulations (CRTs) are 

universally recognized as being highly 

inefficient to support analysis and 

review. The data in paper CRTs are not 

machine-readable and therefore cannot 

be easily analyzed using modern 

analytic software. Although submission 

of clinical study data in electronic 

format has become relatively routine, 

these data are often submitted using 

nonstandard formats. 

FDA has long recognized the 

advantage of standardizing study data, 

as have many sponsors and applicants. 

Data submitted in a standard electronic 

format are easier to understand, analyze, 

and review. 

This draft guidance establishes FDA’s 

recommendation that sponsors and 

applicants submit clinical and 

nonclinical study data in a standard 

electronic format. As sponsors and 

applicants move toward standardized 

electronic study data submissions, there 

is a need to understand FDA’s 

expectations for such data submissions. 

This draft guidance provides FDA’s 

current thinking on the submission of 

study data in a standard electronic 

format. 

The draft guidance refers submitters 

to FDA’s Study Data Standards Resource 

Web page at http://www.fda.gov/For

Industry/DataStandards/StudyData

Standards/default.htm, where there is 

useful information describing which 

data standards to use and how to use 

them. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on submitting standardized study data 

in electronic format. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

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