Federal Register / Vol. 75, No. 188 / Wednesday, September 29, 2010 / Notices 60129 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) Ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

Ways to minimize the burden of the 

collection of information on those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact Dr. 

Cathrine Sasek, Coordinator, Science 

Education Program, Office of Science 

Policy and Communications, National 

Institute on Drug Abuse, 6001 Executive 

Blvd, Room 5237, Bethesda, MD 20892, 

or call non-toll-free number (301) 443– 

6071; fax (301) 443–6277; or by e-mail 

to csasek@nida.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30-days of the date of 

this publication. 

Dated: September 22, 2010. 

Mary Affeldt, 

Executive Officer, (OM Director, NIDA). 

[FR Doc. 2010–24400 Filed 9–28–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Required Data Elements for 

Paternity Establishment Affidavits. 

OMB No.: 0970–0171. 

Description: Section 466(a)(5)(C)(iv) of 

the Social Security Act the Act) requires 

States to develop and use an affidavit 

for the voluntary acknowledgement of 

paternity. The affidavit for the voluntary 

acknowledgement of paternity must 

include the minimum requirements 

specified by the Secretary under section 

452(a)(7) of the Act. The affidavits will 

be used by hospitals, birth record 

agencies, and other entities participating 

in the voluntary paternity establishment 

program. 

Respondents: State and Tribal IV–D 

agencies, hospitals, birth record 

agencies and other entities participating 

in the voluntary paternity establishment 

program. 

ANNUAL BURDEN ESTIMATES

Instrument Number of respondents 

Number of responses per 

respondent 

Average burden hours per 

response 

Total burden 

hours 

Estimated Total Annual Burden 

Hours: 0 

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 Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail 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 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: September 22, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–24212 Filed 9–28–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0482] 

Draft Guidance for Industry and 

Investigators on Safety Reporting 

Requirements for Investigational New 

Drug Applications and Bioavailability/ 

Bioequivalence Studies; 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 and investigators entitled 

‘‘Safety Reporting Requirements for 

INDs and BA/BE Studies.’’ This draft 

guidance is intended to help sponsors 

and investigators comply with the new 

requirements in the final rule entitled 

‘‘Investigational New Drug Safety 

Reporting Requirements for Human 

Drug and Biological Products and Safety 


erowe on DSK5CLS3C1PROD with NOTICES