67732 Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices 

In Section VIII, strike the sentence 

‘‘This Declaration has not previously 

been amended.’’ and replace it with: 

‘‘This is the first amendment to this 

Declaration. The Original Declaration 

was published in the Federal Register at 

72 FR 4710.’’

All other provisions of the Original 

declaration remain in full force. 

This amendment to the Declaration 

will be published in the Federal 

Register pursuant to section 319F–

3(b)(4) of the Act. 

DATES: This notice and the attached 

declaration are effective November 30, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

RADM W. Craig Vanderwage, MD, 

Assistant Secretary for Preparedness 

and Response, Office of the Secretary, 

Department of Health and Human 

Services, 200 Independence Avenue, 

SW., Washington, DC 20201, Telephone 

(202) 205–2882 (this is not a toll-free 

number). 

Dated: November 21, 2007. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. 07–5884 Filed 11–29–07; 8:45 am] 

BILLING CODE 4150–37–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) allow the renewal of the 

generic information collection project: 

‘‘AHRQ Grants Reporting System 

(GRS).’’ In accordance with the 

Paperwork Reduction Act of 1995, 

Public Law 104–13 (44 U.S.C. 

3506(c)(2)(A)), AHRQ invites the public 

to comment on this proposed 

information collection. 

DATES: Comments on this notice must be 

received by December 31, 2007. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, 540 

Gaither Road, Room #5036, Rockville, 

MD 20850, or by e-mail at 

doris.lefkowitz@ahrq.hhs.gov. 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from AHRQ’s Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ, Reports 

Clearance Officer, (301) 427–1477. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

‘‘AHRQ Grants Reporting System 

(GRS)’’

AHRQ has identified the need to 

establish a systematic method for its 

grantees to report project progress and 

important preliminary findings for 

grants funded by the Agency. The 

proposed system will address the 

shortfalls in the current reporting 

process and establish a consistent and 

comprehensive grants reporting solution 

for AHRQ. Currently, AHRQ receives 

grants continuation applications on an 

annual basis from all grantees. The 

progress report, which represents a 

portion of the annual continuation 

application, is inadequate because it is 

too infrequent and does not necessarily 

capture the information that AHRQ 

requires to respond to internal and 

external inquiries. The reporting system 

will also provide a centralized 

repository of grants research 

information that can be used to support 

initiatives within the Agency’s research 

plans for the future and to support 

activities such as performance 

monitoring, budgeting, knowledge 

transfer as well as strategic planning. 

AHRQ currently conducts quarterly 

conference calls with some grantees. 

The content, frequency, and focus of 

these calls vary. In some grant programs, 

the number of participants on these 

calls may be so large as to prohibit 

quarterly updates from all participants 

in order to avoid creating an extremely 

lengthy conference call and to allow the 

Agency to address other important 

issues during these calls. The GRS will 

support the timely collection of 

important information related to the life 

cycle of a grant. This information 

includes: Significant changes in project 

goals, methods, study design, sample or 

subjects, interventions, evaluation, 

dissemination, training, key personnel, 

key preliminary findings; significant 

problems and resolutions; publications 

and presentations; tools and products; 

and new collaborations/partnerships 

with AHRQ grantees or others 

conducting related research. Collecting 

this information in a systematic manner 

will: 

• Promote the transfer of critical 

information more frequently and 

efficiently which will enhance the 

Agency’s ability to support research 

designed to improve the outcomes and 

quality of health care, reduce its costs, 

and broaden access to effective services. 

• Increase the efficiency of the 

Agency in responding to ad-hoc 

information requests, Freedom of 

Information Act requests, and producing 

responses related to federally mandated 

programs and regulations. 

• Establish a consistent approach 

throughout the Agency for information 

collection about grant progress and a 

systematic basis for oversight and for 

facilitating potential collaboration with 

or among grantees. 

• Decrease the inconvenience and 

burden on grantees of unanticipated 

adhoc requests for information by the 

Agency in response to particular (onetime) internal and external requests for 

information. 

This proposed information collection 

was previously published in the Federal 

Register on September 17th, 2007 and 

allowed 60 days for public comment. No 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. This 

project was previously approved by 

OMB on November 10th, 2004. The 

OMB control number is 0935–0122 and 

will expire on November 30th, 2007. 

Data Confidentiality Provisions 

Confidential commercial information 

will be protected in accordance with 18 

U.S.C. 1905. Information about 

Principal Investigators will be 

maintained in accordance with the 

Privacy Act, 5 U.S.C. 552a. Also, 

individuals and organizations will be 

assured of the confidentiality of their 

data under section 934(c) of the 

Healthcare Research and Quality Act of 

1999. The submitted reports will be 

printed and included in the official file 

for each grant. All of these files will be 

retained according to existing agency 

policies and procedures and archived as 

required. The data will be collected 

using a Web based reporting interface 

developed specifically for the purpose 

of collecting information quarterly. To 

reduce burden and to the extent 

possible, these forms will be 

prepopulated with reoccurring 

information needed to specifically 

identify the institution, project, 

principal investigator, and other similar 

information. 


rwilkins on PROD1PC63 with NOTICES
Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices 67733 

1This notice requests comments on the 

information collection in current part 207. In the 

Federal Register of August 29, 2006 (71 FR 51276), 

FDA proposed to revise part 207. The proposed 

revisions would reorganize, consolidate, clarify, 

and modify current regulations concerning who 

must register establishments and list, and describes 

when and how to register and list and what 

information must be submitted for registration and 

listing. In addition, the proposal would make 

certain changes to the National Drug Code (NDC) 

system and would require the appropriate NDC 

number to appear on the labels for drugs subject to 

the listing requirements. The proposed regulations 

generally also require the electronic submission of 

all registration and most listing information. The 

August 29, 2006, proposed rule requested 

comments on the information collection for revised 

part 207. When the proposal is finalized, the 

Continued 

EXHIBIT 1.—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Data entry into GRS ........................................................................................ 500 3 10/60 250 

.

Total .......................................................................................................... 500 na na 250 

EXHIBIT 2.—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Total burden 

hours 

Average 

hourly 

wage rate* 

Total cost 

burden 

Data entry into GRS ........................................................................................ 500 250 $30.00 $7,500 

.

Total .......................................................................................................... 500 250 na 7,500

*Based upon the average wages, ‘‘National Compensation Survey: Occupational Wages in the United States, May 2006,’’ U.S. Department of 

Labor, Bureau of Labor Statistics. 

This information collection will not 

impose a cost burden on the 

respondents beyond that associated 

with their time to provide the required 

data. There will be no additional costs 

for capital equipment, software, 

computer services, etc. 

Estimated Annual Costs to the Federal 

Government 

The annual cost to the government is 

$100,000 for licensing, support and 

maintenance. 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) Whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ health care research and health 

care information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) of 

information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: November 26, 2007. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 07–5886 Filed 11–29–07; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0323] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Registration of 

Producers of Drugs and Listing of 

Drugs in Commercial Distribution 

AGENCY: Food and Drug Administration, 

HHS. 

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 December 

31, 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, or e-mailed to 

baguilar@omb.eop.gov. All comments 

should be identified with the OMB 

control number 0910–0045. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Karen L. Nelson, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4816. 

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. 

Comment Request; Registration of 

Producers of Drugs and Listing of Drugs 

in Commercial Distribution—(OMB 

Control Number 0910–0045—Extension) 

Under section 510 of the Federal 

Food, Drug, and Cosmetic Act (the act), 

(21 U.S.C. 360), FDA is authorized to 

establish a system for registration of 

producers of drugs and for listing of 

drugs in commercial distribution. To 

implement section 510 of the act, FDA 

issued part 207 (21 CFR part 207). 

Under current1 21 CFR 207.20, 


rwilkins on PROD1PC63 with NOTICES