Federal Register / Vol. 69, No. 27 / Tuesday, February 10, 2004 / Notices 6309

restricted devices. Ordinarily, these 

categories include promotional 

messages disseminated by or on behalf 

of a drug or device firm recommending 

use of a drug or device or containing 

some claim of safety or effectiveness for 

a drug or device. One of the principal 

requirements for labeling and 

advertising is the disclosure of risk 

information (either the full FDAapproved professional labeling or the 

brief summary). The labeling and 

advertising rules do not apply to certain 

other forms of communication by or on 

behalf of drug and device firms. One of 

these categories is disease awareness 

communications.

The Disease Awareness Guidance is 

intended to eliminate any confusion as 

to what principles FDA will apply in 

determining whether communications 

by or on behalf of drug and device firms 

qualify as ‘‘labeling’’or ‘‘advertising,’’ or 

as disease awareness communications. 

FDA believes that firms are already 

engaged in a substantial amount of 

disease awareness communication 

aimed at consumers (so-called ‘‘helpseeking’’ communications). 

Manufacturers may, however, be less 

familiar with disease awareness 

communications directed at health care 

professionals. Accordingly, this draft 

guidance contains examples of materials 

currently distributed to health care 

practitioners by government entities and 

educational organizations about health 

conditions to help demonstrate to drug 

and device firms the kinds of disease 

awareness materials they might also 

disseminate. FDA believes that this will 

encourage firms to distribute disease 

awareness information not only to 

patients, but also to health care 

practitioners, thereby encouraging more 

widespread diagnosis and treatment of 

under-diagnosed and under-treated 

health conditions.

The draft guidance also addresses the 

important issue of when disease 

awareness communications become 

subject to FDA regulation as ‘‘labeling’’

or ‘‘advertising’’ by virtue of their 

presentation in combination with socalled ‘‘reminder’’ advertisements or 

labeling or product-claim 

advertisements or labeling.

C. The Device Broadcast Advertising 

Guidance

In 1999, FDA issued final guidance to 

industry on a manner in which 

consumer-directed broadcast 

advertisements for prescription drugs 

could satisfy statutory and regulatory 

requirements for the presentation of risk 

information. The Device Broadcast 

Advertising Guidance adopts the same 

approach for restricted devices, with 

minor revisions recognizing the 

differences in statutory provisions 

relating to prescription drugs and 

restricted devices.

III. Good Guidance Practices

These draft guidances are being 

issued consistent with FDA’s good 

guidance practices (GGPs) regulations 

(21 CFR 10.115). They represent the 

agency’s current thinking on certain 

issues relating to certain types of 

communications about medical 

products and health conditions. They 

do not create or confer any rights for or 

on any person and do not operate to 

bind FDA or the public. Alternative 

approaches may be used if such 

approaches satisfy the requirements of 

the applicable statutes and regulations.

IV. Comments

FDA specifically requests comments 

on the following issues:

1. The Device Broadcast Advertising 

Guidance, like its CDER counterpart 

issued in 1999, does not address the 

meaning of ‘‘major statement’’ in 

§202.1(e)(1) (21 CFR 202.1(e)(1)). 

Should FDA issue guidance on this 

issue? If the agency should, what should 

the guidance provide?

2. The Brief Summary Guidance 

contemplates that firms will disclose 

risk information in their consumerdirected print advertisements for 

prescription drugs in ways that focus on 

the most serious and the most common 

risks, and explains that this includes all 

warnings, all contraindications, and 

certain precautions and adverse events. 

Does the draft guidance provide 

sufficiently concrete advice on this 

point? If it does not, how should the 

guidance be revised?

In the guidance documents 

themselves, FDA requests comments on 

the following issues:

1. In the Brief Summary Guidance, 

FDA requests comments, suggestions, or 

results of research to help the agency 

assess ways in which risk information 

can be presented to consumers (e.g., in 

a text box with accompanying brief 

summary-type disclosure, or in the main 

body of the advertisement without such 

accompanying disclosure).

2. In the Disease Awareness 

Guidance, FDA requests comments on 

whether data exist that help establish 

specific criteria for defining ‘‘close 

physical or temporal proximity’’ to use 

in evaluating whether bookend-type 

communications are within FDA’s 

‘‘labeling’’ or ‘‘advertising’’ authority 

under the act.

Interested persons may submit written 

or electronic comments on the draft 

guidances to the Division of Dockets 

Management (see ADDRESSES). Two 

copies of any comments are to be 

submitted, except that individuals may 

submit one copy. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. Comments should identify 

clearly which guidance they are 

commenting on. The draft guidances 

and received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

V. Electronic Access

Persons with access to the Internet 

may obtain the documents at http://

www.fda.gov/cder/guidance/index.htm, 

http://www.fda.gov/cber/guidelines, or 

http://www.fda.gov/ohrms/dockets/

default.htm.

Dated: February 4, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–2728 Filed 2–5–04; 9:36 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0277]

Draft Guidance for Industry on Time 

and Extent Applications; 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 entitled ‘‘Time and Extent 

Applications.’’ This guidance is being 

written to assist those persons interested 

in adding a new condition to the overthe-counter (OTC) drug monograph 

system. A time and extent application 

(TEA) can be submitted for FDA to 

determine whether a condition is 

eligible to be considered for inclusion in 

an OTC drug monograph. This guidance 

is designed to clarify issues concerning 

the TEA in an effort to facilitate the 

application process.

DATES: Submit written or electronic 

comments on the draft guidance by 

April 12, 2004. General comments on 

agency guidance documents are 

welcome at any time.

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

6310 Federal Register / Vol. 69, No. 27 / Tuesday, February 10, 2004 / Notices 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the draft 

guidance 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.fda.gov/dockets/ecomments. See

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document.

FOR FURTHER INFORMATION CONTACT:

Matthew R. Holman, Center for Drug 

Evaluation and Research (HFD–560), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

(301) 827–2222.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Time and Extent Applications.’’ The 

OTC drug monograph system was 

established to evaluate the safety and 

effectiveness of all OTC drug products 

for the following reasons: (1) Marketed 

in the United States before May 11, 

1972, that were not covered by new 

drug applications (NDAs), and (2) 

covered by ‘‘safety’’ NDAs that were 

marketed in the United States before 

enactment of the 1962 drug 

amendments to the Federal Food, Drug, 

and Cosmetic Act (the act). In 1972, 

FDA began its OTC drug review of the 

following procedures: (1) To evaluate 

OTC drugs by categories or classes (e.g., 

antacids, skin protectants), rather than 

on a product-by-product basis, and (2) 

to develop ‘‘conditions’’ under which 

classes of OTC drugs are generally 

recognized as safe and effective (GRAS/

E) and not misbranded.

FDA publishes these conditions in the 

Federal Register in the form of OTC 

drug monographs, which consist 

primarily of active ingredients, labeling, 

and other general requirements. Final 

monographs for OTC drugs that are 

GRAS/E and not misbranded are 

codified in part 330 (21 CFR part 330). 

Manufacturers seeking to market an 

OTC drug covered by an OTC drug 

monograph need not obtain FDA 

approval before marketing.

Previously, interested persons had to 

prepare and submit an NDA if they 

wanted to introduce into the United 

States an OTC drug condition that had 

been marketed solely in a foreign 

country. Companies also had to submit 

an NDA if their OTC drug products were 

initially marketed in the United States 

after the OTC drug review began in 

1972. In the Federal Register of January 

23, 2002 (67 FR 3060), FDA published 

a final rule that amended the OTC drug 

review procedures in part 330 and 

included additional criteria and 

procedures for classifying OTC drugs as 

GRAS/E and not misbranded. The final 

rule provided procedures for conditions 

that previously required an NDA for 

those conditions to become eligible for 

inclusion in the OTC drug monograph 

system. This final rule stated that an 

applicant must first submit a TEA to 

show marketing ‘‘to a material extent’’

and ‘‘for a material time.’’ Once FDA 

has determined eligibility, safety and 

effectiveness data would be submitted 

and evaluated. This two-step process 

allows applicants to demonstrate that 

eligibility criteria are met before 

expending resources to prepare safety 

and effectiveness data.

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices (GGPs) regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the agency’s 

current thinking on time and extent 

applications. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations.

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see

ADDRESSES) written or electronic 

comments on the draft guidance. Two 

copies of mailed comments are to be 

submitted, except that individuals may 

submit one copy. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. The draft guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet 

may obtain the document at either http:/

/www.fda.gov/cder/guidance/index.htm

or http://www.fda.gov/ohrms/dockets/

default.htm.

Dated: January 29, 2004.

William K. Hubbard,

Associate Commissioner for Policy and 

Planning.

[FR Doc. 04–2729 Filed 2–9–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Availability of Funds for Loan 

Repayment Program for Repayment of 

Health Professions Educational Loans

AGENCY: Indian Health Services, HHS.

ACTION: Notice.

SUMMARY: The Administration’s budget 

request for Fiscal Year (FY) 2004 

includes $11,923,500 for the Indian 

Health Service (IHS) Loan Repayment 

Program (LRP) for health professions 

educational loans (undergraduate and 

graduate) in return for full-time clinical 

service in Indian health programs. It is 

anticipated that $11,846,474 will be 

available to support approximately 276 

competing awards averaging $43,000 

per award for a two year contract. 

This program announcement is 

subject to the appropriation of funds. 

this notice is being published early to 

coincide with the recruitment activity of 

the IHS, which competes with other 

Government and private health 

management organizations to employ 

qualified health professionals. Funds 

must be expended by September 30 of 

the fiscal year. This program is 

authorized by section 108 of the Indian 

Health Care Improvement Act (IHCIA) 

as amended, 25 U.S.C. 1601 et seq. The 

IHS invites potential applicants to 

request an application for participation 

in the LRP.

DATES: Applications for the FY 2004 

LRP will be accepted and evaluated 

monthly beginning March 12, 2004, and 

will continue to be accepted each month 

thereafter until all funds are exhausted. 

Subsequently monthly deadline dates 

are scheduled for Friday of the second 

full week of each month. Notice of 

awards will be mailed on the last 

working day of each month. 

Loan Repayment Awards will be 

made only to those individuals serving 

at facilities which have a site score of 70 

or above during the first and second 

quarters and the first month of the third 

quarter of FY 2004, if funding is 

available. 

Applicants selected for participation 

in the FY 2004 program cycle will be 

expected to begin their service period 

no later than September 30, 2004. 

Applications shall be considered as 

meeting the deadline if the are either: 

1. Received on or before the deadline 

date; or 

2. Sent on or before the deadline date. 

(Applicants should request a legibly 

dated U.S. Postal Service postmark or 

obtain a legibly dated receipt from a