Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices 67731 

Background 

Bisphenol A (CAS RN: 80–5–07) is a 

high production volume chemical used 

in the production of epoxy resins, 

polyester resins, polysulfone resins, 

polyacrylate resins, polycarbonate 

plastics, and flame retardants. 

Polycarbonate plastics are used in food 

and drink packaging; resins are used as 

lacquers to coat metal products such as 

food cans, bottle tops, and water supply 

pipes. Some polymers used in dental 

sealants and tooth coatings contain 

bisphenol A. Exposure to the general 

population can occur through direct 

contact to bisphenol A or by exposure 

to food or drink that has been in contact 

with a material containing bisphenol A. 

CERHR selected this chemical for 

evaluation because of (1) high 

production volume, (2) widespread 

human exposure, (3) evidence of 

reproductive toxicity in laboratory 

animal studies, and (4) public concern. 

The CERHR convened an expert panel 

on March 5–7, 2007, and on August 6–

8, 2007, to review and revise the draft 

and interim draft expert panel reports 

and reach conclusions regarding 

whether exposure to bisphenol A is a 

hazard to human development or 

reproduction. The expert panel also 

identified data gaps and research needs. 

CERHR solicited public comments on 

drafts of the expert panel report several 

times (FR, December 12, 2006, Vol. 71, 

No. 238 pp. 74534–74536; FR, April 2, 

2007, Vol. 72, No. 62 pp. 15695–15696; 

FR, May 1, 2007, Vol. 72, No. 83 pp. 

23833–23834). 

Following receipt of public comments 

on the final bisphenol A expert panel 

report, CERHR staff will prepare the 

NTP–CERHR monograph. NTP–CERHR 

monographs are divided into four major 

sections: (1) The NTP Brief that 

provides the NTP’s interpretation of the 

potential for the chemical to cause 

adverse reproductive and/or 

developmental effects in exposed 

humans, (2) a roster of expert panel 

members, (3) the final expert panel 

report, and (4) public comments 

received on that report. The NTP Brief 

is based on the expert panel report, 

public comments on that report, public 

and peer review comments on the draft 

NTP Brief, and any new, relevant 

information that becomes available after 

the expert panel meetings. 

Request for Comments 

CERHR invites written public 

comments on the bisphenol A expert 

panel report. Written comments should 

be sent to Dr. Michael Shelby (see 

ADDRESSES above). Persons submitting 

written comments are asked to include 

their name and contact information 

(affiliation, mailing address, telephone 

and facsimile numbers, e-mail, and 

sponsoring organization, if any). Any 

comments received will be posted on 

the CERHR Web site and included in the 

NTP CERHR monograph on this 

chemical. All public comments will be 

considered by the NTP during 

preparation of the NTP Brief (see 

‘‘Background’’ above). 

Background Information on CERHR 

The NTP established the CERHR in 

June 1998 [FR, December 14, 1998 (Vol. 

63, No. 239, pp. 68782)]. CERHR is a 

publicly accessible resource for 

information about adverse reproductive 

and/or developmental health effects 

associated with exposure to 

environmental and/or occupational 

exposures. Expert panels conduct 

scientific evaluations of agents selected 

by CERHR in public forums. 

CERHR invites the nomination of 

agents for review or scientists for its 

expert registry. Information about 

CERHR and the nomination process can 

be obtained from its Web site (http:// 

cerhr.niehs.nih.gov) or by contacting Dr. 

Shelby (see ADDRESSES above). CERHR 

selects chemicals for evaluation based 

upon several factors including 

production volume, potential for human 

exposure from use and occurrence in 

the environment, extent of public 

concern, and extent of data from 

reproductive and developmental 

toxicity studies. 

CERHR follows a formal, multi-step 

process for review and evaluation of 

selected chemicals. A description of the 

evaluation process is available on the 

CERHR Web site under ‘‘About CERHR’’

or in printed copy from CERHR. 

Dated: November 15, 2007. 

Samuel H. Wilson, 

Acting Director, National Institute of 

Environmental Health Sciences and National 

Toxicology Program. 

[FR Doc. E7–23234 Filed 11–29–07; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Amendment to January 26, 2007 

Declaration Under the Public 

Readiness and Emergency 

Preparedness Act 

AGENCY: Office of the Assistant 

Secretary for Preparedness and 

Response (ASPR), HHS. 

ACTION: Amendment (to the January 26, 

2007 Declaration under the Public 

Readiness and Emergency Preparedness 

Act). 

SUMMARY: Declaration pursuant to 

section 319F–3 of the Public Health 

Service Act (42 U.S.C. 247d–6d) to 

provide targeted liability protections for 

pandemic countermeasures based on a 

credible risk that avian influenza 

viruses spread and evolve into strains 

capable of causing a pandemic of 

human influenza. 

Amendment: Whereas, the H7 and H9 

subtypes of avian influenza viruses are 

viewed as likely candidates to evolve 

into an influenza virus strain capable of 

causing a pandemic of human influenza; 

and 

Whereas, in accordance with section 

319F–3(b)(6) of the Public Health 

Service Act (42 U.S.C. 247d–6d(b)) (‘‘the 

Act’’), I have considered the desirability 

of encouraging the design, development, 

clinical testing or investigation, 

manufacturing and product formulation, 

labeling, distribution, packaging, 

marketing, promotion, sale, purchase, 

donation, dispensing, prescribing, 

administration, licensing, and use of 

these additional medical 

countermeasures with respect to the 

category of diseases and population 

described in sections II and IV of the 

declaration published in Federal 

Register on February 1, 2007 (72 FR 

4710) (‘‘the Original Declaration’’); 

Therefore, pursuant to section 319F–

3(b) of the Act, I have determined there 

is a credible risk that the spread of the 

H7 and H9 subtypes of avian influenza 

viruses and resulting disease could in 

the future constitute a public health 

emergency. In order to reflect the 

addition of medical countermeasures 

specific to the H7 and H9 subtypes of 

influenza viruses, the Original 

Declaration is hereby amended as 

follows: 

First ‘‘whereas’’ clause, first sentence, 

insert ‘‘H7 and H9 vaccines’’ following 

‘‘(H5N1).’’

Second ‘‘whereas’’ clause, first 

sentence, insert ‘‘H7 and H9’’ following 

‘‘H5N1’’ to read ‘‘Whereas an H5N1, [H7 

and H9] avian influenza viruse[s] may 

evolve into strain[s] * * *.’’

In Section I, paragraph 2, first 

sentence insert ‘‘H7 and H9’’ following 

‘‘(H5N1)’’ to read ‘‘* * * pandemic 

countermeasure influenza A (H5N1, [H7 

and H9]) vaccine[s].’’

In Section I, paragraph 2, third 

sentence insert ‘‘H7 and H9’’ following 

‘‘(H5N1)’’ to read ‘‘* * * pandemic 

countermeasure influenza A (H5N1, [H7 

and H9]) vaccine[s] * * *.’’

In Section II, paragraph 1, insert ‘‘or 

an H7 or H9’’ following ‘‘(H5N1).’’


rwilkins on PROD1PC63 with NOTICES
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