20356 Federal Register / Vol. 76, No. 70 / Tuesday, April 12, 2011 / Notices 

Dated: March 31, 2011. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2011–8654 Filed 4–11–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: State Plan for Child Support 

under IV–D of the Social Security Act. 

OMB No.: 0970–0017. 

Description: The Office of Child 

Support Enforcement has approved a 

IV–D State plan for each State. Federal 

regulations require States to amend their 

State plans only when necessary to 

reflect new or revised Federal statutes or 

regulations or material change in any 

State law, organization, policy, or IV–D 

agency operations. The requirement for 

submission of a State plan and plan 

amendments for the Child Support 

Enforcement program is found in 

sections 452, 454, and 466 of the Social 

Security Act. 

Respondents: State IV–D Agencies. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

State Plan ........................................................................................................ 54 8 0.50 216

OCSE–21–U4 .................................................................................................. 54 8 0.25 108 

Estimated Total Annual Burden 

Hours: 324. 

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. 2011–8666 Filed 4–11–11; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Statewide Automated Child 

Welfare Information System (SACWIS) 

Assessment Review Guide (SARG). 

OMB No.: 0970–0159. 

Description: For HHS to fulfill its 

obligation to effectively serve the 

nation’s Adoption and Foster Care 

populations, and to report meaningful 

and reliable information to Congress 

about the extent of problems facing 

these children and the effectiveness of 

assistance provided to this population, 

the agency must have access to timely 

and accurate information about child 

welfare service populations and child 

welfare services. Section 476(b)of the 

Social Security Act requires that States 

submit statistical reports for child 

welfare populations, and Section 479 of 

the Act details State responsibilities to 

report specific information related to 

child abuse and neglect. CFR 1355.52 

provides funding authority for statewide 

automated child welfare information 

systems (SACWIS) that meet Federal 

requirements for child welfare data 

collection. If a State chooses to 

implement a SACWIS, that system 

serves as the primary data source for 

Federal reporting. Currently, states use 

their SACWIS to support their efforts to 

meet the following Federal reporting 

requirements related to child welfare: 

the Adoption and Foster Care Analysis 

and Reporting System (AFCARS) 

required by section 479(b)(2) of the 

Social Security Act; the National Child 

Abuse and Neglect Data System 

(NCANDS); Child Abuse Prevention and 

Treatment Act (CAPTA); and the Chafee 

Independent Living Program’s National 

Youth in Transition Database (NYTD). 

These systems also support state efforts 

to provide the information to conduct 

the Child and Family Service Reviews. 

Currently, forty-two States and the 

District of Columbia have developed, or 

are developing, a SACWIS with Federal 

financial participation. 

45 CFR 1355.55 provides for 

continuing review, assessment and 

inspection of SACWIS. The purpose of 

this review is to determine whether the 

system, as described in the approved 

Advance Planning Document has been 

adequately completed and conforms to 

applicable regulations and policies. 

To initiate a review, States complete 

and submit the SACWIS Assessment 

Review Guide (SARG) and other system 

documentation when they have 

completed system development and the 

system is operational statewide. The 

SARG template provides a format for 

State description of system 

functionality, operation, and outputs 

such as reports. The additional 

materials submitted as part of this 

process, such as system design 

documentation, are typically readily 

available to the State as a result of good 

project management practices. 

The information collected in the 

SACWIS Assessment Review Guide will 

allow Federal reviewers to determine if 

the State’s SACWIS meets the 

requirements for title IV–E Federal 

Financial Participation (FFP) defined at 

45 CFR 1355.50, and that systems meet 

the goals and objectives of the approved 

Advance Planning Documents (APD) 

and conforms to the schedule, budget, 


srobinson on DSKHWCL6B1PROD with NOTICES
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