Federal Register / Vol. 77, No. 84 / Tuesday, May 1, 2012 / Notices 25719 

Performance Report is required by 

federal statute. Each State 

Developmental Disabilities Council 

must submit an annual report for the 

preceding fiscal year of activities and 

accomplishments. Information provided 

in the Program Performance Report will 

be used (1) in the preparation of the 

biennial Report to the President, the 

Congress, and the National Council on 

Disabilities and (2) to provide a national 

perspective on program 

accomplishments and continuing 

challenges. This information will also 

be used to comply with requirements in 

the Government Performance and 

Results Act of 1993. 

Respondents: State Councils. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

State Council on Developmental Disabilities Program Performance Report .. 56 1 138 7,590 

Estimated Total Annual Burden 

Hours: 7,590. 

Additional Information 

Copies of the proposed collection may 

be obtained 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. All 

requests should be identified by the title 

of the information collection. Email 

address: infocollection@acf.hhs.gov. 

OMB Comment 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: Office of 

Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–7285, 

Email: 

OIRA_SUBMISSION@OMB.EOP.GOV. 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2012–10426 Filed 4–30–12; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Title: Measure Development: Quality 

of Family-Provider Relationships in 

Early Care and Education. 

OMB No.: New collection. 

Description 

The Office of Planning, Research and 

Evaluation (OPRE), the Administration 

for Children and Families (ACF), U.S. 

Department of Health and Human 

Services (HHS), is proposing a data 

collection activity as part of the 

development of an early care and 

education (ECE) quality measurement 

tool to assess family-provider 

relationships that support positive child 

developmental outcomes and family 

wellbeing. The major goal of this project 

is to develop a measure of the quality 

of family-provider relationships that 

will be (1) applicable across multiple 

types of early care and education 

settings and diverse program structures 

(including Head Start/Early Head Start); 

(2) sensitive across cultures associated 

with racial, ethnic, and socioeconomic 

characteristics; and (3) reliable in both 

English and Spanish. At this time, four 

self-administered surveys (one for 

center- and home-based care directors, 

one for child care providers/teachers, 

and two for parents) and an 

environmental checklist have been 

developed, based on a literature review, 

a review of existing measures, and 

information collected through focus 

groups (under OMB Clearance 0970– 

0356) and cognitive interviews (under 

OMB Clearance 0970–0355). 

To test these measures, two stages of 

data collection activities are proposed 

for this information collection request: 

A pilot test and a field test. 

The pilot test data will be used to 

examine the distribution of the items 

and to determine whether they behave 

in a manner consistent with the 

conceptual model that was developed as 

part of the project. The pilot test will 

also test data collection procedures 

prior to conducting a large-scale field 

test. Any problematic items or 

procedures identified by the pilot test 

will be corrected and revisions 

submitted to OMB before the field test. 

The purpose of the field test is to 

obtain sufficient data on a diverse 

population to enable full psychometric 

testing of the measures and compare 

subgroups to ensure that the measure 

can be used in diverse ECE settings. 

Respondents: In both the pilot and the 

field tests, the respondents will include 

directors of center—based child care 

programs, home-based child care 

programs, Early Head Start programs, 

and Head Start programs; center-based 

and home-based child care providers 

and ECE teachers; and parents whose 

children are enrolled in these diverse 

types of ECE settings. 

ANNUAL BURDEN ESTIMATE—PILOT AND FIELD TESTS

Instrument 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total annual 

burden hours 

Screening questions ........................................................................................ 945 1 0.05 47 

Director Survey ................................................................................................ 143 1 0.08 11 

Provider/Teacher Survey ................................................................................. 253 1 0.17 43 

Parent Survey about FSWs ............................................................................. 76 1 0.17 13 

Parent Survey about Teachers ........................................................................ 475 1 0.17 81 

Environmental Checklist .................................................................................. 945 1 0.17 161 

Estimated Total Annual Burden Hours: 356. 

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25720 Federal Register / Vol. 77, No. 84 / Tuesday, May 1, 2012 / Notices 

In compliance with the requirements 

of Section 3506(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: OPRE Reports Clearance Officer. 

Email address: 

OPREinfocollection@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 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. 

Dated: April 23, 2012. 

Steven Hanmer, 

Reports Clearance Officer. 

[FR Doc. 2012–10305 Filed 4–30–12; 8:45 am] 

BILLING CODE 4184–22–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–P–0025] 

Determination That GRIFULVIN V 

(Griseofulvin Microcrystalline) Tablets, 

250 Milligrams, Was 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 GRIFULVIN V (griseofulvin 

microcrystalline) tablets, 250 milligrams 

(mg), was not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for griseofulvin 

microcrystalline tablets, 250 mg, if all 

other legal and regulatory requirements 

are met. 

FOR FURTHER INFORMATION CONTACT: 

Nancy Hayes, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6244, 

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 (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. 

GRIFULVIN V (griseofulvin 

microcrystalline) tablets, 250 mg, is the 

subject of ANDA 062279, held by 

OrthoNeutrogena, and approved on June 

2, 1980. GRIFULVIN V is indicated for 

the treatment of certain ringworm 

infections (tinea corporis, tinea pedis, 

tinea cruris, tinea barbae, tinea capitis, 

and tinea unguium) when caused by a 

certain genera of fungi. 

GRIFULVIN V (griseofulvin 

microcrystalline) tablets, 250 mg, is 

currently listed in the ‘‘Discontinued 

Drug Product List’’ section of the Orange 

Book. 

Arthur Y. Tsien of Olsson Frank 

Weeda Terman Bode Matz PC submitted 

a citizen petition on behalf of a client, 

dated January 7, 2011 (Docket No. FDA– 

2011–P–0025), under 21 CFR 10.30, 

requesting that the Agency determine 

whether GRIFULVIN V (griseofulvin 

microcrystalline) tablets, 250 mg, was 

withdrawn from sale for reasons of 

safety or effectiveness. After considering 

the citizen petition and reviewing 

Agency records, FDA has determined 

under § 314.161 that GRIFULVIN V 

(griseofulvin microcrystalline) tablets, 

250 mg, was not withdrawn for reasons 

of safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that GRIFULVIN 

V (griseofulvin microcrystalline) tablets, 

250 mg, was withdrawn for reasons of 

safety or effectiveness. We have 

carefully reviewed our files for records 

concerning the withdrawal of 

GRIFULVIN V (griseofulvin 

microcrystalline) tablets, 250 mg, from 

sale. We have also independently 

reviewed relevant literature and data for 

possible postmarketing adverse event 

reports. 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 GRIFULVIN V 

(griseofulvin microcrystalline) tablets, 

250 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 GRIFULVIN V 

(griseofulvin microcrystalline) tablets, 

250 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. 

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