Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Notices 27573 

Families (TANF) under Sections 101–

103, 106–110, 112, 115, and 116 of the 

Personal Responsibility and Work 

Opportunity Reconciliation Act of 1996, 

42 U.S.C. 1305 note, 42 U.S.C. 601 et 

seq., and as amended now and hereafter. 

In addition, in exercising authority 

under Section 103, ‘‘Section 413, 

Research, Evaluations, and National 

Studies,’’ of the Social Security Act, the 

Director, Office of Family Assistance, 

Administration for Children and 

Families, is expected to consult with the 

Department of Health and Human 

Services, Assistant Secretary for 

Planning and Evaluation. 

3. Authority to administer the 

provisions of the Adult Assistance (AA) 

Programs under Titles I, X, XIV and XVI 

(Grants to States for Aid to the Aged, 

Blind and Disabled) of the Social 

Security Act, and as amended now and 

hereafter. 

4. Authority under Section 1119 of 

the Social Security Act, and as amended 

now and hereafter, to approve Federal 

financial participation in payments for 

repairs to homes owned by recipients of 

aid or assistance under Titles I, X, XIV, 

or XVI. 

(b) Limitations 

1. This delegation of authority shall 

be exercised under the Department’s 

existing policies on delegations and 

regulations. 

2. This delegation of authority does 

not include the authority to submit 

reports to Congress and shall be 

exercised under financial and 

administrative requirements applicable 

to all Administration for Children and 

Families’ authorities. 

3. The approval or disapproval of 

grant applications requires concurrence 

of the appropriate Grants Officer. The 

approval or disapproval of contract 

proposals and awards are subject to the 

requirements of the Federal Acquisition 

Regulations and requires the 

concurrence of the Contracting Officer. 

4. The authority to approve/ 

disapprove under 45 CFR 205.55(d) 

State applications to use alternate 

sources of information for income and 

eligibility (i.e., IEVS) requires 

consultation with the Office of the 

Deputy Assistant Secretary for 

Administration and with the other 

programs affected by the request. 

5. This delegation of authority does 

not include the authority to issue 

annual rankings of States’ most and 

least successful work programs and outof-wedlock birth ratios under Sections 

413(d)(1) and 413(e)(1) of the Social 

Security Act. 

6. This delegation of authority does 

not include the authority under sections 

409(a) or 412(g) of the Social Security 

Act to make determinations regarding 

State or tribal compliance or 

performance or technical 

noncompliance and to impose penalties 

and the authority under section 410(a) 

of the Social Security Act to issue 

notices to States or tribes regarding the 

imposition of such penalties. 

7. This delegation of authority does 

not include the authority to sign and 

issue notices of grant awards for family 

assistance programs. 

8. This delegation of authority does 

not include the authority to appoint 

Central Office and Regional Office Grant 

Officers for the administration of family 

assistance programs. 

9. This delegation of authority does 

not include the authority to appoint 

Action Officials for Audit Resolution. 

10. This delegation of authority does 

not include the authority to conduct 

research under sections 413(a), (b), and 

(h) of the Social Security Act or to 

review proposals and approve State 

funding for evaluations of Title IV–A 

programs under section 413(f) of the 

Social Security Act. 

11. This delegation of authority 

excludes the authority to hold hearings. 

12. This delegation of authority does 

not include the authority to approve or 

disapprove State requests for Federal 

financial participation for the costs of 

automated data processing equipment 

and services which affect more than one 

HHS Operating Division. 

13. This delegation of authority does 

not include the authority to make 

determinations on State appeals 

concerning audit questions or 

recommendations by the Department of 

Health and Human Services (HHS) 

Audit Agency which involve ACF 

program practices reviewed under Titles 

I, X, XI and XVI of the Social Security 

Act. 

14. This delegation of authority does 

not include the authority to disapprove 

Adult Assistance State Plans and 

amendments. 

15. This delegation of authority does 

not include the authority to approve or 

disapprove TANF work participation 

plans. 

16. This delegation of authority does 

not include the authority to sign official 

policy transmittals such as Action 

Transmittals, Information Memoranda, 

etc. 

17. This delegation of authority does 

not include the authority to approve or 

disapprove corrective compliance plans 

or make reasonable cause 

determinations. 

18. This delegation of authority does 

not include the authority to make 

determinations that TANF plans are 

incomplete. 

19. This delegation of authority does 

not include the authority to disapprove 

Tribal TANF and Tribal NEW plans or 

amendments. 

20. This delegation of authority does 

not include the authority to take 

disallowances in Tribal NEW programs. 

21. This delegation of authority does 

not include the authority to approve or 

disapprove discretionary grant 

applications under section 403(a)(2) of 

the Social Security Act. 

22. The issuance of new policy 

interpretations require the concurrence 

of the Director, OFA. 

23. Actions likely to have a significant 

impact on State or Tribes, or 

discretionary grantees or have political 

ramifications or be subject to or receive 

adverse publicity shall be brought to the 

prior attention of the Director, OFA. 

24. Any redelegation shall be in 

writing and prompt notification must be 

provided to all affected managers, 

supervisors, and other personnel, and 

requires the concurrence of the Deputy 

Assistant Secretary for Administration. 

(c) Effective Date 

This delegation of authority was 

effective on April 17, 2007. 

(d) Effect on Existing Delegations 

As related to the authorities delegated 

herein, this delegation of authority 

supersedes all previous delegations of 

authority to the Associate Director, 

TANF. 

I hereby affirm and ratify any actions 

taken by the Associate Director, TANF, 

Office of Family Assistance, which 

involved the exercise of the authorities 

delegated herein prior to the effective 

date of this delegation. 

Dated: May 9, 2007. 

Sidonie Squier, 

Director, Office of Family Assistance. 

[FR Doc. E7–9420 Filed 5–15–07; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0041] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Administrative 

Procedures for the Clinical Laboratory 

Improvement Amendments of 1988 

Categorization 

AGENCY: Food and Drug Administration, 

HHS. 


cprice-sewell on PROD1PC66 with NOTICES
27574 Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Notices 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by June 15, 

2007. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974. All comments should be 

identified with the OMB Control 

Number 0910–NEW and the title 

‘‘Administrative Procedures for the 

Clinical Laboratory Improvement 

Amendments of 1988 Categorization.’’

Also include the FDA docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

1472. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance: 

Administrative Procedures for the 

Clinical Laboratory Improvement 

Amendments of 1988 Categorization (42 

CFR 493.17) 

A draft guidance document entitled 

‘‘Guidance for Administrative 

Procedures for Clinical Laboratory 

Improvement Amendments of 1988 

Categorization’’ (CLIA) was released for 

comment on August 14, 2000. The 

document describes procedures FDA 

will use to assign the complexity 

category to a device. Typically, FDA 

assigns complexity categorizations to 

devices at the time of clearance or 

approval of the device. In this way, no 

additional burden is incurred by the 

manufacturer since the labeling 

(including operating instructions) is 

included in the 510(k) or premarket 

approval (PMA). In some cases, 

however, a manufacturer may request 

CLIA categorization even if FDA is not 

simultaneously reviewing a 510(k) or 

PMA. One example is when a 

manufacturer requests that FDA assign 

CLIA categorization to a previously 

cleared device that has changed names 

since the original CLIA categorization. 

Another example is when a device is 

exempt from premarket review. In such 

cases, the guidance recommends that 

manufacturers provide FDA with a copy 

of the package insert for the device and 

a cover letter indicating why the 

manufacturer is requesting a 

categorization (e.g., name change 

exempt from 510(k) review). The draft 

guidance recommends that in the 

correspondence to FDA the 

manufacturer should identify the 

product code and classification as well 

as reference to the original 510(k) when 

this is available. 

A previous 60-day notice that 

published August 14, 2000 (65 FR 

49582), announced the availability of a 

draft guidance and did not include a 

Paperwork Analysis Section. This 60- 

day notice for public comment 

supersedes that notice and is correcting 

that error. 

In the Federal Register of February 

14, 2007 (72 FR 7043), FDA published 

a 60-day notice soliciting public 

comment on the proposed collection of 

information requirements. In response 

to that notice, no comments were 

received. 

The likely respondents for this 

collection are Investigational New Drug 

Application sponsors. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

42 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Total Operating & 

Maintenance 

Costs 

493.17 60 15 900 1 900 $45,000 

Total 60 15 900 1 900 $45,000 

1There are no capital costs associated with this collection of information. 

The number of respondents is 

approximately 60. On average, each 

respondent will request categorizations 

(independent of a 510(k) or PMA) 15 

times per year. The cost, not including 

personnel, is estimated at $50. This 

includes the cost of copying and mailing 

copies of package inserts and a cover 

letter, which includes a statement of the 

reason for the request and reference to 

the original 510(k) numbers, including 

regulation numbers and product codes. 

Dated: May 10, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–9435 Filed 5–15–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0494] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Cosmetic Labeling Regulations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Cosmetic Labeling Regulations’’ has 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of December 4, 2006 

(71 FR 70411), the agency announced 

that the proposed information collection 

had been submitted 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 


cprice-sewell on PROD1PC66 with NOTICES