72740 Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Notices 

Therefore, FDA required that the terms 

‘‘some types of cancer’’ or ‘‘some 

cancers’’ be used in specifying the 

disease for this health claim 

relationship (id.). The antioxidant and 

cancer and selenium and cancer 

qualified health claims also contain 

similar language, i.e., ‘‘certain forms of 

cancer,’’ to be used in specifying the 

disease. However, in other qualified 

health claims for a substance and cancer 

relationship (Refs. 6, 7, and 8), the 

agency considered separate qualified 

health claims for each type of cancer. 

Cancer is a constellation of more than 

100 different diseases, each 

characterized by the uncontrolled 

growth and spread of abnormal cells 

(Ref. 9). Cancer is categorized into 

different types of diseases based on the 

organ and tissue sites (Ref. 10). Cancers 

at different organ sites have different 

risk factors, treatment modalities, and 

mortality risk (Ref. 9). Both genetic and 

environmental (including diet) risk 

factors may affect the risk of different 

types of cancers. Risk factors may 

include a family history of a specific 

type of cancer, cigarette smoking, 

alcohol consumption, overweight and 

obesity, exposure to ultraviolet or 

ionizing radiation, exposure to cancercausing chemicals, and dietary factors. 

The etiology, risk factors, diagnosis, and 

treatment for each type of cancer are 

unique (Refs. 11 and 12). Because each 

form of cancer is a unique disease based 

on organ site, risk factors, treatment 

options, and mortality risk, FDA’s 

current approach is to evaluate each 

form of cancer individually in a health 

claim or qualified health claim petition 

to determine whether the scientific 

evidence supports the potential 

substance-disease relationship for any 

type of cancer, each of which 

constitutes a disease under 

§ 101.14(a)(5). 

The agency intends to consider, as 

part of its reevaluation of the scientific 

evidence for dietary fat, antioxidant, 

and selenium and their association with 

a reduced risk of cancer, claim language 

to reflect specific types of cancer rather 

than ‘‘certain forms of cancer’’ (or 

similar language). 

II. How to Submit Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individual may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that in January 2008, the 

FDA Web site is expected to transition 

to the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. After the transition 

date, electronic submissions will be 

accepted by FDA through the FDMS 

only. When the exact date of the 

transition to FDMS is known, FDA will 

publish a Federal Register notice 

announcing that date. 

III. References 

The following references have been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. (FDA has verified the 

Web site addresses, but we are not 

responsible for subsequent changes to 

the Web sites after this document 

publishes in the Federal Register.) 

1. Balk E, Chung M, Chew P, Ip S, Raman 

G, Kupelnick B, Tatsioni A, Sun Y, Wolk B, 

DeVine D, Lau J. Effects of Soy on Health 

Outcomes. Summary, Evidence Report/ 

Technology Assessment No. 126. (Prepared 

by the Tufts-New England Medical Center 

Evidence-based Practice Center under 

Contract No. 290–02–0022.) AHRQ 

Publication No. 05–E024–1. Rockville, MD: 

Agency for Healthcare Research and Quality. 

July 2005. 

2. Institute of Medicine, National Academy 

of Sciences. Dietary Referece Intakes for 

energy, carbohydrate, fiber, fat, fatty acids, 

cholesterol, protein and amino acids, 

Chapter 11 page 808. National Academy 

Press. Washington, D.C. 2005. 

3. Antioxidant vitamins and risk of certain 

cancers, April 1, 2003, http://www.cfsan.

fda.gov/~dms/ds-ltr34.html. 

4. Selenium and certain cancers, February 

21, 2003, Docket No. 2002P–0457 (formerly 

Docket No. 02P–0457), http://www.cfsan.

fda.gov/~dms/ds-ltr35.html. 

5. Huang HY, Caballero B, Chang S, Alberg 

A, Semba R, Schneyer C, Wilson RF, Cheng 

TY, Prokopowicz G, Barnes II GJ, Vassy J, 

Bass EB. Multivitamin/Mineral Supplements 

and Prevention of Chronic Disease. Evidence 

Report/Technology Assessment No. 139. 

(Prepared by The Johns Hopkins University 

Evidence-based Practice Center under 

Contract No. 290–02–0018). AHRQ 

Publication No. 06–E012. Rockville, MD: 

Agency for Healthcare Research and Quality. 

May 2006. 

6. Tomatoes and prostate, ovarian, gastric 

and pancreatic cancers, November 8, 2005, 

Docket No. 2004Q–0201, http://www.cfsan.

fda.gov/~dms/qhclyco.html. 

7. Green tea and prostate and breast cancer 

risk, June 30, 2005, Docket No. 2004Q–0083, 

http://www.cfsan.fda.gov/~dms/qhcgtea.html. 

8. Calcium and colon/rectal, breast and 

prostate cancers and recurrent polyps, 

October 12, 2005, Docket No. 2004Q–0097, 

http://www.cfsan.fda.gov/~dms/ 

qhcca2.html. 

9. American Cancer Society, Cancer Facts 

and Figures, 2004. 

10. National Cancer Institute, Dictionary of 

Cancer Terms, http://www.cancer.gov/ 

Templates/db_alpha.aspx?CdrID=45333. 

11. Hord NG, Fenton JI. Context is 

everything: mining the normal and 

preneoplastic microenvironment for insights 

into the diet and cancer risk conundrum. 

Molecular Nutrition and Food Research, 

2007, 51:100–106. 

12. Milner JA. Diet and Cancer: Facts and 

Controversies. Nutrition and Cancer, 2006, 

56:216–224. 

Dated: December 6, 2007. 

Barbara Schneeman, 

Director, Office of Nutritional Products, 

Labeling, and Dietary Supplements, Center 

for Food Safety and Applied Nutrition. 

[FR Doc. E7–24813 Filed 12–20–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Announcement of Potential Eligibility 

for Compensation Under Public 

Readiness and Emergency 

Preparedness Act Declaration and 

Filing Deadlines 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Notice. 

SUMMARY: This Notice provides 

notification that individuals who have 

been injured by pandemic, epidemic, or 

security countermeasures identified in a 

declaration issued by the Secretary 

pursuant to section 319F–3(b) of the 

Public Health Service Act (PHS Act) (42 

U.S.C. 247d–6d) have one (1) year from 

the time they receive the covered 

countermeasure to file requests for 

compensation for injuries directly 

resulting from administration or use of 

covered countermeasures under the 

Public Readiness and Emergency 

Preparedness Act (PREP Act). 

DATES: This Notice is effective on 

December 21, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Healthcare Systems Bureau, Health 

Resources and Services Administration, 

Parklawn Building, Room 11C–26, 5600 

Fishers Lane, Rockville, Maryland 

20857; toll-free telephone number 

1–888–496–0338. Electronic inquiries 

should be sent via Tamara Overby at 

toverby@hrsa.gov. 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Notices 72741 

SUPPLEMENTARY INFORMATION: The PREP 

Act, which is a part of the ‘‘Department 

of Defense, Emergency Supplemental 

Appropriations to Address Hurricanes 

in the Gulf of Mexico, and Pandemic 

Influenza Act of 2006’’ (Pub. L. 109–

148), was enacted on December 30, 

2005, and confers broad liability 

protections on covered persons, as 

defined in section 319F–3(i)(2) of the 

PHS Act, and compensation to 

individuals injured by the receipt of 

covered countermeasures, as defined in 

section 319F–3(i)(1) of the PHS Act, in 

the event of designated public health 

emergencies. A covered countermeasure 

means: (A) A qualified pandemic or 

epidemic product (as defined in section 

319F–3(i)(7) of the PHS Act); (B) a 

security countermeasure (as defined in 

section 319F–2(c)(1)(B) of the PHS Act); 

or (C) a drug (as such term is defined in 

section 201(g)(1) of the Federal Food, 

Drug and Cosmetic Act (21 U.S.C. 

321(g)(1)), biological product (as such 

term is defined by section 351(i) of this 

Act), or device (as such term is defined 

by section 201(h) of the Federal Food, 

Drug and Cosmetic Act (21 U.S.C. 

321(h)) that is authorized for emergency 

use in accordance with section 564 of 

the Federal Food, Drug and Cosmetic 

Act. 

Passed primarily to address the 

pandemic influenza threat, the PREP 

Act provides liability protections after a 

Secretarial declaration of covered 

countermeasures for any disease or 

health condition that the Secretary 

views as constituting a public health 

emergency, either presently or in the 

future. Liability protections cover the 

manufacture, testing, development, 

distribution, or use of the designated 

covered countermeasure absent willful 

misconduct as defined in section 319F–

3(c)(1) of the PHS Act. A Secretarial 

declaration specifies the categories of 

health threats or conditions for which 

countermeasures are recommended, the 

period liability protections are in effect, 

the population of individuals protected, 

and the geographic areas for which the 

protections are in effect. 

In addition to liability protections, the 

PREP Act provides the Secretary the 

authority, which was delegated by the 

Secretary on November 8, 2006 to the 

Administrator of the Health Resources 

and Services Administration, to 

compensate eligible individuals for 

covered injuries from a covered 

countermeasure. 

The first Declaration under the PREP 

Act was published in the Federal 

Register on February 1, 2007 (72 FR 

4710). It designated the pandemic 

influenza A (H5N1) vaccine as a covered 

countermeasure, with an effective time 

period of December 1, 2006–February 

28, 2010. As a result of this Declaration, 

individuals injured by this vaccine can 

file a request for compensation. 

Individuals have one (1) year from the 

time they receive the vaccine to apply 

for compensation. Currently, no funds 

have been appropriated to provide 

compensation. However, all potential 

claims must still be filed within the one 

(1) year limit. 

This Declaration specifies that the 

following individuals with covered 

injuries may be eligible to receive 

compensation under the PREP Act: (1) 

All persons who use a covered 

countermeasure or to whom such a 

covered countermeasure is administered 

as an Investigational New Drug in a 

human clinical trial conducted directly 

by the Federal Government, or pursuant 

to a contract, grant or cooperative 

agreement with the Federal 

Government; (2) all persons who use a 

covered countermeasure or to whom 

such a countermeasure is administered 

in a pre-pandemic phase; and/or (3) all 

persons who use a covered 

countermeasure, or to whom such a 

covered countermeasure is administered 

in a pandemic phase. The Pre-Pandemic 

Phase means the following stages, as 

defined in the National Strategy for 

Pandemic Influenza: Implementation 

Plan (Homeland Security Council, May 

2006): (0) New Domestic Animal 

Outbreak in At-Risk Country; (1) 

Suspected Human Outbreak Overseas; 

(2) Confirmed Human Outbreak 

Overseas; and (3) Widespread Human 

Outbreaks in Multiple Locations 

Overseas. The Pandemic Phase means 

the following stages, as defined in the 

National Strategy for Pandemic 

Influenza: Implementation Plan 

(Homeland Security Council, May 

2006): (4) First Human Case in North 

America; and (5) Spread Throughout 

United States. 

Eligible individuals may be 

compensated for out-of-pocket medical 

expenses, lost employment income, and 

survivor death benefits. Reasonable and 

necessary medical items and services 

may be paid or reimbursed to treat a 

covered countermeasure-related injury 

of an eligible individual. The payments 

or reimbursements for services or 

benefits are secondary to other forms of 

coverage. The individual may receive 

compensation for loss of employment 

income incurred as a result of the 

covered countermeasure injury. The 

amount of compensation is based on 

income at the time of injury. Death 

benefits may be paid to certain survivors 

of covered countermeasures recipients 

who have died as a direct result of the 

covered countermeasure injury. Since 

HHS is payer of last resort, payments are 

reduced by those of other third party 

payers. 

Interested parties may obtain request 

packages that contain copies of all 

necessary forms and instructions by 

writing to the Healthcare Systems 

Bureau, Health Resources and Services 

Administration, Parklawn Building, 

Room 11C–26, 5600 Fishers Lane, 

Rockville, MD 20857, calling at 1–888–

496–0338, or downloading them from 

the HRSA Web site at http:// 

www.hrsa.gov/countermeasurescomp. 

Completed request packages must be 

postmarked by the U.S. Postal Service, 

a commercial carrier, or a private 

courier service. HRSA will not accept 

request packages electronically or by 

hand-delivery. The postmark date is 

used to determine whether the filing 

deadline of one year from receipt of the 

countermeasure has been met. 

Paperwork Reduction Act of 1995 

HRSA will submit to the Office of 

Management and Budget (OMB) an 

Information Collection Request (ICR) for 

approval of the required forms. 

Dated: December 18, 2007. 

Elizabeth M. Duke, 

Administrator. 

[FR Doc. 07–6180 Filed 12–19–07; 1:36 pm] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Cancer Care for Uninsured 

Individuals: A Feasibility Study (NCI) 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Cancer Institute (NCI) of the 

National Institutes of Health (NIH) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection 

Title: Cancer Care For Uninsured 

Individuals: A Feasibility Study. Type 

of Information Collection Request: 

NEW. Need and Use of Information 

Collection: The purpose of this 

information collection is to conduct a 

pilot study to assess the feasibility of 

obtaining health insurance information 

for participants of the Prostate, Lung, 

Colon and Ovarian (PLCO) Cancer 

Screening Trial participants from health 

mstockstill on PROD1PC66 with NOTICES