Federal Register / Vol. 76, No. 70 / Tuesday, April 12, 2011 / Notices 20357 

and other conditions of their approved 

APDs. Additionally, other States may be 

able to use the documentation provided 

as part of their preparation for the 

review process of their own system 

development efforts. 

Respondents: Title IV–E Agencies. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

SACWIS Assessment Review Guide .............................................................. 3 1 250 750 

Estimated Total Annual Burden 

Hours: 750. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 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. E-mail 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, 

E-mail: 

OIRA_SUBMISSION@OMB.EOP.GOV, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2011–8663 Filed 4–11–11; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–P–0256] 

Determination That KEFLEX 

(Cephalexin) Capsule, Equivalent to 

333 Milligrams Base, 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Withdrawn From Sale for Reasons of 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 KEFLEX (cephalexin) capsule, 

equivalent to (EQ) 333 milligrams (mg) 

base, was not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for cephalexin 

capsule, EQ 333 mg base, if all other 

legal and regulatory requirements are 

met. 

FOR FURTHER INFORMATION CONTACT: 

Patrick Raulerson, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6368, 

Silver Spring, MD 20993–0002, 301– 

796–3522. 

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 approved 

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, 

a drug is 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). 

Under § 314.161(a)(1) (21 CFR 

314.161(a)(1)), the Agency must 

determine whether a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness before an ANDA 

that refers to that listed drug may be 

approved. FDA may not approve an 

ANDA that does not refer to a listed 

drug. 

KEFLEX (cephalexin) capsule, EQ 333 

mg base, is the subject of NDA 050405 

held by Victory Pharma, Inc., and the 

333-mg strength was approved on May 

12, 2006. KEFLEX is a cephalosporin 

antibiotic indicated for the treatment of 

respiratory tract infections caused by 

Streptococcus pneumoniae and S. 

pyogenes, as well as certain other 

infections caused by susceptible strains 

of certain designated micro-organisms 

as described in the product labeling. 

KEFLEX (cephalexin) capsule, EQ 333 

mg base, has never been marketed. In 

previous instances (see 72 FR 9763, 

March 5, 2007; 61 FR 25497, May 21, 

1996), 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 May 

29, 2009 (Docket No. FDA–2009–P– 

0256), under 21 CFR 10.30, requesting 

that the Agency determine whether 

KEFLEX (cephalexin) capsule, EQ 333 

mg base, 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 

KEFLEX (cephalexin) capsule, EQ 333 

mg base, was not withdrawn for reasons 

of safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that KEFLEX 

(cephalexin) capsule, EQ 333 mg base, 

was withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of KEFLEX 

(cephalexin) capsule, EQ 333 mg base, 

from sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events. We have found no information 


srobinson on DSKHWCL6B1PROD with NOTICES
20358 Federal Register / Vol. 76, No. 70 / Tuesday, April 12, 2011 / Notices 

that would indicate that this product 

was withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list KEFLEX (cephalexin) 

capsule, EQ 333 mg base, 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 KEFLEX (cephalexin) capsule, EQ 

333 mg base, 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: April 6, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8617 Filed 4–11–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases 

Diabetes Mellitus Interagency 

Coordinating Committee; Notice of 

Workshop 

The Diabetes Mellitus Interagency 

Coordinating Committee (DMICC) will 

hold a 2-day workshop on May 5, from 

8 a.m. to 6 p.m., and May 6, from 

7:30 a.m. to 4 p.m., at the Hilton 

Washington DC/Rockville Hotel & 

Executive Meeting Center, 1750 

Rockville Pike, Rockville, MD 20852. 

The workshop will be open to the 

public, with attendance limited to space 

available. Non-Federal individuals 

planning to attend the workshop should 

register on the workshop Web site 

(http://conferences.thehillgroup.com/ 

NIDDK/DMICCworkshop/index.html) at 

least 7 days prior to the workshop. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

inform the Contact Person listed below 

at least 10 days in advance of the 

workshop. 

The DMICC facilitates cooperation, 

communication, and collaboration on 

diabetes among government entities. 

The May 5–6, 2011, DMICC workshop 

will discuss new and emerging 

opportunities for type 1 diabetes 

research supported by the Special 

Statutory Funding Program for Type 1 

Diabetes Research. 

Any interested person may file 

written comments with the Committee 

by forwarding their statement to the 

Contact Person listed on this notice. The 

statement should include the name, 

address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Because of time constraints for the 

workshop, there will not be time on the 

agenda for oral comments from 

members of the public. 

An agenda for the DMICC workshop 

will be available on the following Web 

site: http:// 

conferences.thehillgroup.com/NIDDK/ 

DMICCworkshop/index.html. Members 

of the public who would like to receive 

e-mail notification about future DMICC 

meetings could register on a listserv 

available on the DMICC Web site: 

http://www.diabetescommittee.gov. 

For further information concerning 

this workshop, contact Dr. Sanford 

Garfield, Executive Secretary of the 

Diabetes Mellitus Interagency 

Coordinating Committee, National 

Institute of Diabetes and Digestive and 

Kidney Diseases, 6707 Democracy 

Boulevard, Room 654, MSC 5460, 

Bethesda, MD 20892–5460, Telephone: 

301- 594–8803 Fax: 301–402–6271, 

E-mail: dmicc@mail.nih.gov. 

Dated: April 4, 2011. 

Sanford Garfield, 

Executive Secretary, DMICC, Division of 

Diabetes, Endocrinology and Metabolic 

Diseases, NIDDK, National Institutes of 

Health. 

[FR Doc. 2011–8612 Filed 4–11–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Career Enhancement Award for Stem Cell 

Research. 

Date: May 4, 2011. 

Time: 12:30 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call) 

Contact Person: William J. Johnson, PhD, 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7178, Bethesda, MD 20892–7924, 301–435– 

0725, johnsonwj@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: April 5, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–8610 Filed 4–11–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The concept review and 

evaluation discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel; Folic Acid/Zinc 

Sulfate Supplementation, Semen Quality, 

and Ovulation Induction/IVF Outcomes. 

Date: April 12, 2011. 

Time: 2 p.m. to 3 p.m. 

Agenda: To review and evaluate concept 

review. 


srobinson on DSKHWCL6B1PROD with NOTICES