Federal Register / Vol. 73, No. 190 / Tuesday, September 30, 2008 / Notices 56829 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Title Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

.103(b)(4), .109(d) IRB Actions, .116 and .117 Informed Consent ............... 6,000 39 .33 1 235,980 

.115(a) IRB Recordkeeping ........................................................................... 6,000 15 10 900,000 

.103(b)(5) Incident Reporting, .113 Suspension or Termination Reporting .. 6,000 0 .5 45/60 2,250 

Total ........................................................................................................ ........................ .......................... ........................ 1,138,230 

Seleda Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. E8–22976 Filed 9–29–08; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency Information Collection 

Request, 30-Day Public Comment 

Request, Grants.Gov; 30-Day Notice 

AGENCY: Office of the Secretary, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Office of the Secretary (OS), Department 

of Health and Human Services, is 

publishing the following summary of a 

proposed collection for public 

comment. Interested persons are invited 

to send comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, e-mail your request, 

including your address, phone number, 

OMB number, and OS document 

identifier, to 

Sherette.funncoleman@hhs.gov, or call 

the Reports Clearance Office on (202) 

690–5683. Send written comments and 

recommendations for the proposed 

information collections within 30 days 

of this notice directly to the OS OMB 

Desk Officer; faxed to OMB at 202–395– 

6974. 

Proposed Project: SF–424 

Individual—Revision—OMB No. 4040– 

0005—Grants.gov. 

Abstract: This is a request for a 

revision of a previously approved 

collection. It is a simplified, alternative 

government-wide data set and 

application cover page for use by 

Federal grant-making agencies that 

award grants to individuals. The form is 

being revised with changes to the data 

field that collects the Social Security 

Number (SSN). The SSN field is an 

optional field. The current collection 

pre-fills the first five digits with ‘‘xxxxx’’ and only collects the last four digits 

of the SSN. At OMB’s request, we 

reviewed the usefulness of collection of 

a portion of the SSN, by polling the 

Agencies that used the SF–424 

Individual form; however, it was 

determined that the partial SSN is not 

useful for processing the SF–424 

Individual form by the Agencies. 

Therefore, no portion of the SSN will be 

collected as part of the electronic grant 

application process. Frequency of data 

collection varies by Federal agency. 

ESTIMATED ANNUALIZED BURDEN TABLE

Agency Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

NEA .................................................................................................. 1,150 1 10/60 192 

NEH ................................................................................................. 2,593 1 30/60 1,297 

USDA ............................................................................................... 4,069 1 30/60 2,035 

HHS ................................................................................................. 600 1 30/60 300 

Total .......................................................................................... ............................ ............................ ............................ 3,824 

Seleda Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. E8–22977 Filed 9–29–08; 8:45 am] 

BILLING CODE 4151–AE–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Notice of Meeting; National 

Commission on Children and Disasters 

AGENCY: Administration for Children 

and Families, Department of Health and 

Human Services. 

ACTION: Notice, FACA Committee 

Meeting Announcement. 

SUMMARY: Pursuant to Public Law 92– 

463, the Federal Advisory Committee 

Act, as amended (5 U.S.C. Appendix 2), 

notice is hereby given of the First 

Meeting of the National Commission on 

Children and Disasters, Department of 

Health and Human Services. The 

meeting will be held from 

approximately 8:30 a.m. to 5 p.m. on 

Tuesday, October 14, 2008, at the 


ebenthall on PROD1PC60 with NOTICES
56830 Federal Register / Vol. 73, No. 190 / Tuesday, September 30, 2008 / Notices 

Administration for Children and 

Families, 370 L’Enfant Promenade, SW., 

Washington, DC. The meeting will be 

open to the public; however, seating is 

limited and pre-registration is 

encouraged (see below). 

FOR FURTHER INFORMATION CONTACT: 

Roberta Lavin, Office of Human Services 

Emergency Preparedness and Response, 

e-mail roberta.lavin@acf.hhs.gov or 

(202) 401–9306. 

SUPPLEMENTARY INFORMATION: The 

National Commission on Children and 

Disasters (henceforth ‘‘the 

Commission’’) is a commission that 

shall independently conduct a 

comprehensive study to examine and 

assess the needs of children as they 

relate to preparation for, response to, 

and recovery from all hazards, building 

upon the evaluations of other entities 

and avoiding unnecessary duplication 

by reviewing the findings, conclusions, 

and recommendations of these entities. 

The Commission shall then submit a 

report to the President, the Secretary of 

Health and Human Services, and the 

Congress on the Commission’s 

independent and specific findings, 

conclusions, and recommendations to 

address the needs of children as they 

relate to preparation for, response to, 

and recovery from all hazards, including 

major disasters and emergencies. The 

Commission implements the intent of 

Congress as expressed in The 

Consolidated Appropriations Act, 2008 

(Pub. L. 110–161), Division G, Title VI, 

(henceforth ‘‘the Act’’) signed into law 

on December 26, 2007, authorizing 

funds for a body performing the 

functions here assigned to the 

Commission. 

The Commission will hear 

presentations on and discuss: (1) The 

Department of Health and Human 

Services’ efforts to support the needs of 

children in disaster situations; (2) the 

Federal Emergency Management 

Administration’s efforts to support the 

needs of children in disaster situations; 

(3) White House perspectives on the 

Administration’s efforts to support the 

needs of children in disaster situations; 

and (4) plans for future work of the 

Commission. 

The meeting will be open to the 

public; however, seating is limited and 

pre-registration is encouraged. To preregister, please e-mail 

carol.apelt@acf.hhs.gov with ‘‘Meeting 

Registration’’ in the subject line, or call 

Carol Apelt at (202) 205–4618 by 5 p.m. 

EST, October 9, 2008. Registration must 

include your name, affiliation, phone 

number. If you require a sign language 

interpreter or other special assistance, 

please call Carol Apelt at (202) 205– 

4618 as soon as possible and no later 

than October 6, 2008. 

Dated: September 24, 2008. 

Charles Keckler, 

Deputy Assistant Secretary for Policy for 

Children and Families. 

[FR Doc. E8–22939 Filed 9–29–08; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–N–0270] (formerly 

Docket No. 2007N–0357) 

Medical Device User Fee and 

Modernization Act; Notice to Public of 

Web Location of 2009 Proposed 

Guidance Development 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

Web location where the agency will post 

a list of guidance documents the Center 

for Devices and Radiological Health 

(CDRH) is considering for development 

in fiscal year (FY) 2009. In addition, 

FDA has established a docket where 

stakeholders may provide comments 

and/or draft language for those topics as 

well as suggestions for new or different 

guidances. 

DATES: Submit written or electronic 

comments at any time. 

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Deborah A. Wolf, Center for Devices and 

Radiological Health (HFZ–215), Food 

and Drug Administration, 1350 Piccard 

Dr., Rockville, MD 20850, 240–276– 

2350. 

SUPPLEMENTARY INFORMATION: 

I. Background 

During negotiations over the 

reauthorization of the Medical Device 

User Fee and Modernization Act 

(MDUFMA), FDA agreed, in return for 

additional funding from industry, to 

meet a variety of quantitative and 

qualitative goals intended to help get 

safe and effective medical devices to 

market more quickly. These 

commitments include annually posting 

a list of guidance documents that CDRH 

is considering for development and 

providing stakeholders an opportunity 

to provide comments and/or draft 

language for those topics, or suggestions 

for new or different guidances. This 

notice announces the Web location of 

the list of guidances (see § 10.115(c)(1) 

(21 CFR 10.115(c)(1))) on which CDRH 

is intending to work over the next FY. 

We note that the agency is not required 

to issue every guidance on the list, nor 

is it precluded from issuing guidance 

documents that are not on the list. The 

list includes topics that currently have 

no guidance associated with them, 

topics where updated guidance may be 

helpful, and topics for which CDRH has 

already issued level 1 drafts that may be 

finalized following review of public 

comments. We will consider 

stakeholder comments as we prioritize 

our guidance efforts. 

FDA and CDRH priorities are subject 

to change at any time. Topics on this 

and past guidance priority lists may be 

removed or modified based on current 

priorities. We also note that CDRH’s 

experience over the years has shown 

that there are many reasons CDRH staff 

does not complete the entire annual 

agenda of guidances it undertakes. Staff 

are frequently diverted from guidance 

development to other activities, 

including review of premarket 

submissions or postmarket problems. In 

addition, the Center is required each 

year to issue a number of guidances that 

it cannot anticipate at the time the 

annual list is generated. These may 

involve newly identified public health 

issues as well as special control 

guidance documents for de novo 

classifications of devices. It will be 

helpful, therefore, to receive comments 

that indicate the relative priority of 

different guidance topics to interested 

stakeholders. 

Through feedback from stakeholders, 

including draft language for guidance 

documents, CDRH expects to be able to 

better prioritize and more efficiently 

draft guidances that will be useful to 

industry and other stakeholders. This 

will be the second annual list CDRH has 

posted. FDA intends to update the list 

each year. 

FDA invites interested persons to 

submit comments on any or all of the 

guidance documents on the list. FDA 

has established a specific docket (see 

docket number found in brackets in the 

heading of this document) where 

comments about the FY 2009 list, draft 

language for guidance documents on 

those topics, and suggestions for new or 

different guidances may be submitted. 

FDA believes this docket is an 


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