24700 Federal Register / Vol. 65, No. 82 / Thursday, April 27, 2000 / Notices

to conduct the safety education

program.

Budget and Justification (Not Scored)

The extent to which the applicant

provides a detailed budget and narrative

justification consistent with the stated

objectives and planned program

activities.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original and plus

copies of:

1. Semi-annual progress reports;

2. Financial status report, no more

than 90 days after the end of the budget

period; and

3. Final financial and performance

reports, no more than 90 days after the

end of the project period.

Send all reports to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ Section of this

announcement.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment I.

AR–7—Executive Order 12372 Review

AR–8—Public Health System Reporting

Requirements

AR–10—Smoke-Free Workplace

Requirements

AR–11—Healthy People 2010

AR–12—Lobbying Restrictions

AR–13—Prohibition on Use of CDC

Funds for Certain Gun Control

Activities

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

section 301(a), 317(k)(2), 391, 392, 394,

and 394A [42 U.S.C. 241(a), 247b(k)(2),

280b, 280b–1, 280b–2, 280b–3] of the

Public Health Service Act, as amended.

The Catalog of Federal Domestic

Assistance number is 93.136.

J. Where To Obtain Additional

Information

This and other CDC announcements

can be found on the CDC home page on

the Internet: http://www.cdc.gov. If you

have questions after reviewing the

content of all documents, business

management assistance may be obtained

from: Sheryl L. Heard, Grants

Management Specialist Grants

Management Branch, Procurement and

Grants Office, Announcement 00084,

Centers for Disease Control and

Prevention (CDC), 2920 Brandywine

Road, Suite 3000, Atlanta, GA 30341–

4146, Telephone (404) 488–2723, Email:

slh3@cdc.gov

For program technical assistance,

contact: Tim Groza, MPA, Centers for

Disease Control and Prevention,

National Center for Injury Prevention

and Control, 4770 Buford Highway,

N.E., Mailstop K63, Atlanta, GA 30341–

3724, Telephone (770) 488–4676, Email:

tgroza@cdc.gov.

To order a copy of CDC’s

Demonstrating Your Program’s Worth: A

Primer on Evaluation for Programs to

Prevent Unintentional Injury go to:

www.cdc.gov/ncipc/pub-res/

demonstr.htm.

Dated: April 21, 2000.

John L. Williams,

Director, Procurement and Grants Office

Centers for Disease Control, and Prevention

(CDC).

[FR Doc. 00–10486 Filed 4–26–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00074]

Demonstration Projects for the Early

Intervention and Prevention of Sexual

Violence and Intimate Partner Violence

among Racial and Ethnic Minority

Populations; Notice of Availability of

Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of FY 2000 funds for a

cooperative agreement program to:

support the development,

implementation and evaluation of

culturally competent demonstration

projects for the early intervention and

prevention of both sexual violence (SV)

and intimate partner violence (IPV)

among racial and ethnic minority

populations. This program addresses

‘‘Healthy People 2010,’’ a national

activity to reduce morbidity and

mortality and improve health. This

announcement is related to the focus

area of Injury and Violence Prevention.

For the conference copy of ‘‘Healthy

People 2010’’, visit the Internet site:

http://www.health.gov/healthypeople.

B. Eligible Applicants

Applications may be submitted by

public and private non-profit and forprofit community-based organizations

and by governments and their agencies;

that is, universities, colleges, research

institutions, hospitals, other public and

private nonprofit and for-profit

organizations, State and local

governments or their bona fide agents,

and federally recognized Indian tribal

governments, Indian tribes or Indian

tribal organizations. Organizations

serving American Indian or Alaskan

Native tribal entities must have

resolutions from the tribal councils of

the tribes they intend to serve

supporting their application for funding

under this announcement.

The applicant organization or agency

must have at least two years of

experience serving the proposed

population(s). The applicant may

propose services to one or more of the

following racial or ethnic minority

community, i.e., African American,

American Indian or Alaska Native,

Hispanic American, Asian American, or

Pacific Islander. Communities or groups

which cannot be specified under these

categories will not be considered.

Note: Public Law 104–65 states that an

organization described in section 501(c)(4) of

the Internal Revenue Code of 1986 that

engages in lobbying activities is not eligible

to receive Federal funds constituting an

award, grant, cooperative agreement,

contract, loan or any other form.

C. Availability of Funds

Approximately $1.6 million is

available in FY 2000 to fund

approximately three to four awards. It is

expected that the average award will be

$400,00. It is expected that the awards

will begin on or about September 1,

2000, and will be made for a 12-month

budget period within a project period of

up to five years. Funding estimates may

change.

Continuation awards within an

approved project period will be made

on the basis of satisfactory progress as

evidenced by required reports and the

availability of funds.

Use of Funds

Allowable Uses

Funds can be used to support

personnel and to purchase modest

amounts of hardware, and software

required to implement the project.

Applicants may contract with other

organizations under these cooperative

agreements; however, applicants must

perform a substantial portion of the

activities (including program

management and operations and

delivery of prevention and intervention

services) for which funds are requested.

Applications requesting funds to

support only administrative and

managerial functions will not be

accepted.

Prohibited Uses

Funds for this project cannot be used

for construction, renovation, the lease of

Federal Register / Vol. 65, No. 82 / Thursday, April 27, 2000 / Notices 24701

passenger vehicles, the development of

major software applications, or

supplanting current applicant

expenditures.

Funding Preferences

In making awards, preference for

funding may be given to ensuring a mix

of the interventions listed under Section

D, ‘‘Programmatic Interests,’’ of this

announcement as well as a distribution

among ethnic populations or geographic

areas.

D. Programmatic Interests

Each applicant must conduct

(develop, implement, and evaluate) at

least one, but on more than two of the

following priority prevention or early

intervention activities, which addresses

both SV and IPV. Because of the

resources, special expertise, and

organizational capacities needed for

success, applicants should carefully

consider the feasibility of undertaking

more than one of the priority

interventions listed in this section of the

Program Announcement.

Interventions may be focused either

on the individual or the entire family.

The applicant must develop,

implement and evaluate:

1. Culturally competent strategies and

programs aimed at prevention and early

intervention of sexual violence (SV) and

intimate partner violence (IPV), such as

parenting or child development classes,

and support groups for children who

have witnessed SV and IPV or

experienced child abuse, including

child sexual abuse, in conjunction with

witnessing SV and IPV,

2. Culturally competent victim

support prevention and intervention

programs that work through programs

designed to address perpetrators of SV

and IPV and children who witness SV

and IPV or experience child abuse,

including child sexual abuse, in

conjunction with witnessing SV and

IPV.

3. Culturally competent perpetrator

re-education programs that work

through programs designed to address

victims of SV and IPV and children who

witness SV and IPV or experience child

abuse, including child sexual abuse in

conjunction with witnessing SV and

IPV.

4. Culturally competent school or

community-based early intervention/

prevention programs designed to

promote healthy relationships and

prevent dating violence (SV and IPV)

among school-aged youth, whether the

youth are in school or not.

5. Culturally competent school or

community-based prevention and

intervention programs designed to

identify and assist pre-school, schoolaged children and adolescents who

witness SV and IPV or experience child

abuse, including child sexual abuse, in

conjunction with witnessing SV and

IPV.

6. Culturally competent advocacy

programs/strategies that link the

population community’s health care

system, criminal justice system, child

protection service system, SV and IPV

prevention and intervention programs,

and other sectors of the community

deemed appropriate (e.g., the faith

community, traditional healers,

business community) such that victims,

perpetrators, and children who witness

IPV or experience child abuse,

including child sexual abuse, in

conjunction with witnessing SV and

IPV—have access to culturally

competent intervention and prevention

services.

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under 1. (Recipient Activities), and CDC

will be responsible for the activities

listed under 2. (CDC Activities).

1. Recipient Activities:

a. Coordinate and collaborate with

other organizations and agencies

working with the proposed intervention

population(s), especially those involved

in SV and IPV prevention and

intervention.

b. Develop and implement the

proposed activities, in collaboration

with these working partners to prevent

duplication of efforts.

c. Incorporate cultural competency,

linguistic and developmental

appropriateness into all program

activities and prevention messages.

d. If the applicant is a communitybased organization, they must establish

and maintain a full working partnership

with a university, academic institution

of higher education or research institute

to develop their research protocol, data

collection instruments and conduct an

overall evaluation of the proposed

intervention and prevention activities.

Universities, academic institution of

higher education or research institutes

applying for funding are required to

establish and maintain a full working

partnership with a either a communitybased organization or health department

to carry out the proposed intervention

or prevention activities.

e. Develop a research protocol,

including all instruments and consent

documents, for IRB review by all

cooperating institutions participating in

the research project. All IRBs must

review and approve the protocol

initially and on an annual basis until

the research is completed.

f. Compile lessons learned from the

project and facilitate the dissemination

of lessons learned and successful

prevention interventions and program

models.

2. CDC Activities:

a. Provide up-to-date scientific and

programmatic information about SV and

IPV prevention.

b. Assist in the development of a

research protocol for IRB review by all

cooperating institutions participating in

the research project. The CDC IRB will

review and approve the protocol

initially and on at least an annual basis

until the research is completed.

E. Application Content

Use the information in the Program

Requirements, Other Requirements, and

Evaluation Criteria sections to develop

the application content. Your

application will be evaluated on the

criteria listed, so it is important to

follow them in laying out your program

plan. The narrative should be no more

than 50 double-spaced pages, (not

including, attachments, and line item

budget and justifications), printed on

one side, with unreduced 12 point font

on 81⁄2′′ by 11′′ paper, with 1′′ margins,

headings and footers. Number each page

sequentially, including appendices, and

provide a complete Table of Contents to

the application and its appendices. Each

section of the application as defined

under format, shown below, must begin

on a new page. The original and each

copy of the application set must be

submitted unstapled and unbound.

Materials which should be part of the

basic narrative will not be accepted if

placed in the appendices. The applicant

should provide a detailed description of

first year activities and briefly describe

future-year objectives and activities.

In developing the application, you

must follow the format shown below:

Format

1. Abstract

2. Assessment of Need and

Justification of Proposed Activities

3. Organizational History and

Capacity

4. Program Design and Plan of

Operation

5. Program Evaluation Plan

6. Project Management and Staffing

7. Budget and Staffing Breakdown and

Justification

8. Human Subjects

9. Required Attachments

For specific content requirements for

each item shown under ‘‘Format ’’

(above) see details listed in ‘‘Evaluation

Criteria’’ (Section G).

24702 Federal Register / Vol. 65, No. 82 / Thursday, April 27, 2000 / Notices

F. Submission and Deadline

Letter of Intent (LOI)

Although not a prerequisite of the

application, a non-binding letter of

intent-to-apply is requested from

potential applicants. Your letter of

intent should identify the

announcement number, name the

principal investigator, and state which

of the priority prevention and

intervention activities you intend to

conduct if awarded funding. On or

before June 1, 2000, submit the letter of

intent to the Grants Management

Specialist identified in the ‘‘Where to

Obtain Additional Information’’ section

of this announcement.

Application

Submit the original and two copies of

PHS 5161 (OMB Number 0937–0189).

Forms are in the application kit. On or

before July 10, 2000, submit the

application to the Grants Management

Specialist identified in the ‘‘Where to

Obtain Additional Information’’ section

of this announcement.

Deadline: Applications shall be

considered as meeting the deadline if

they are either:

(a) Received on or before the deadline

date; or

(b) Sent on or before the deadline date

and received in time for submission to

the independent review group.

(Applicants must request a legibly dated

U.S. Postal Service postmark or obtain

in a legibly dated receipt from a

commercial carrier or U.S. Postal

Service. Private metered postmarks shall

not be acceptable as proof of timely

mailing.)

Late Applications: Applications

which do not meet the criteria in (a) or

(b) above are considered late

applications, will not be considered,

and will be returned to the applicant.

G. Evaluation Criteria

Each applicant will be evaluated

individually against the following

criteria by a special emphasis panel

(SEP) appointed by CDC.

1. Abstract (Not to Exceed 2 Pages) (Not

Scored)

The extent to which the applicant

summarizes which categories of the six

priority prevention/interventions,

(maximum number of two) listed under

Section D. ‘‘Programmatic Interests’’,

they intend to implement and the extent

to which the abstract contains the

following:

a. Brief summary of the need for the

proposed activities;

b. Short-term and long-term goals;

c. Brief summary of proposed plan of

operation, including the population(s)

to be served, activities to be undertaken

and services to be provided, location of

the services, and the location of the

organization and how it will serve the

local community; and

d. A brief summary of plans for

evaluating the activities of this project.

2. Assessment of Need and Justification

for the Proposed Activities: (15 Points)

The extent to which the applicant:

a. Describes the incidence and

prevalence of sexual violence and

abuse, intimate partner violence and

associated injury and death among the

intervention population(s), for each

intervention proposed;

b. Describes the intervention

population(s), both qualitatively and

quantitatively, for each intervention

proposed, including demographics by

age, sex, socioeconomic status, and

geographic location; and

c. describes the availability and

accessibility of SV and IPV prevention

and intervention programs for the

intervention population(s), as well as

existing gaps and barriers in program

delivery, for each proposed

intervention, and how they will be

addressed.

3. Organizational History and Capacity:

(20 Points)

The extent of the applicant’s

documented experience, capacity, and

ability to address the identified needs

and implement the proposed activities,

including:

a. A description and documentation

of the organization’s record of services

to the target population. A minimum of

two years experience is required;

b. A description of the organizational

management, administrative and

program components;

c. A description of collaborating

organizations or networks;

d. A description of how the

organizational structure will support the

proposed intervention activities; and

how the structure facilitates the capacity

to reach targeted populations;

e. A description of how the

organizational structure includes, or has

the ability to obtain meaningful input

and representation from, members of

each proposed intervention populations;

f. A description of the applicants

experience in developing and

implementing effective SV or IPV

prevention and/or intervention

strategies and activities, and in

developing and implementing

interventions similar to the one(s)

proposed in this application;

g. A description of the mechanisms

used by the organization to monitor

program implementation and quality

assurance;

h. A description of the organizations

experience in coordinating and

collaborating with other organizations

and agencies providing SV and IPV

prevention and intervention services to

the proposed intervention population(s).

Universities, academic institutions of

higher education or research institutes

applying for funding are required to

establish and maintain a full working

partnership with a either a communitybased organization or health department

to carry out the proposed intervention

or prevention activities;

i. A description of the organizations

capacity to provide the proposed

interventions in a manner that is

culturally competent, linguistically and

developmentally appropriate, and

which responds effectively to the

gender, environmental, and social

characteristics of the intervention

population(s); and

j. For any of the above areas in which

the organization does not have direct

experience or current capacity,

describing how they will ensure that the

organization will gain capacity (e.g.,

through staff development,

collaboration with other organizations,

or a contract).

4. Program Design and Plan of

Operation: (25 Points)

The extent to which the applicant:

a. Describes the specific program

goals that remain consistent during the

five-year project period, as well a shortterm (year one) objectives and long-term

(years two-five) objectives related to the

project and the extent to which the goals

are feasible and objectives are clear,

time-phased, specific, measurable, and

will achieve the desired program

results;

b. Describes a theoretical framework

outlining the rationale for the

development, implementation and

evaluation of proposed activities;

c. Describes outcomes, which are

theoretically or empirically justified to

result from program activities;

d. Describes or provides samples of

proposed data collection instruments

that are appropriate for collecting

information relevant to the project;

e. Program planning time line is

realistic and provides sufficient detail

about who will do what and when; and

f. Describes how the organization will

meet the CDC policy requirements

regarding the inclusion of women,

ethnic, and racial groups in the

proposed project. Including:

1. The proposed plan for the inclusion

of both sexes and racial and ethnic

minority populations for appropriate

representation;

Federal Register / Vol. 65, No. 82 / Thursday, April 27, 2000 / Notices 24703

2. The proposed justification when

representation is limited or absent;

3. A statement as to whether the

design of the project is adequate to

measure differences when warranted;

and

4. A statement as to whether the plans

for recruitment and outreach for

participants include the process of

establishing partnerships with

community(ies) and recognition of

mutual benefits.

5. Program Evaluation Plan: (25 Points)

The extent to which the applicant’s

evaluation plan:

a. Describes the process to be used in

developing and implementing the

proposed intervention(s) evaluation;

b. Describes the process to be used in

developing and implementing the

working partner(s) activities evaluation;

c. Describes the process for

identifying existing gaps in programs as

well as other needs in the community;

d. Describes the extent to which

intended short-term outcomes that may

be achieved will be measured;

e. Describes how the change in shortterm outcomes resulting from the

respective prevention and early

intervention activities from baseline to

project completion, including, at a

minimum, a six-month postintervention follow-up, will be

measured;

f. Describes the evaluation design;

g. Describes the methods for

collecting process and outcome data,

and for ensuring reliability and validity

of all data collected;

h. Describes how data will be

maintained (i.e., databases);

i. Describes the applicant’s and

proposed academic and community

working partners’ capacity (facilities,

computers) for collecting and managing

data;

j. Describes the statistical techniques

to be used for analyzing the data;

k. Describes how client

confidentiality and safety will be

addressed and maintained;

l. Describes how staff performance

will be assessed to ensure they are

providing information and services

accurately and effectively.

If the applicant is a community-based

organization, the extent to which items

(a–l) were developed in full working

partnership with a university, academic

institution of higher education or

research institute.

6. Project Management and Staffing: (15

Points)

The extent to which the applicant has

experience in the management and

delivery of intimate partner violence

primary prevention programs at the

community level and:

a. Describes how the proposed project

will be managed and staffed, noting

existing staff as well as additional

staffing needs;

b. Describes the roles and

responsibilities, skills and experience of

the applicant’s program staff and any

working partner’s staff;

c. Provides an organizational chart of

the applicant’s and working partner’s

organizations showing how the

proposed project will be integrated into

these organizations; and

d. Provides evidence that a full-time

Program Manager (one individual, one

full-time equivalent) and the equivalent

of a full-time Program Evaluator will be

available for the entire project.

7. Budget/Staffing Breakdown and

Justification: (Not Scored)

The extent to which the budget

request is clearly explained, adequately

justified, reasonable, sufficient for the

proposed project activities, and

consistent with the intended use of the

cooperative agreement funds.

8. Human Subjects: (Not Scored)

The extent to which the applicant

complies with the Department of Health

and Human Services Regulations (45

CFR Part 46) regarding the protection of

human subjects.

9. Required Attachments: (Not Scored)

The extent to which the applicant

complies with providing the following:

a. Memoranda of understanding or

agreement as evidence of established or

agreed-upon collaborative relationships.

Memoranda of agreement should

specifically describe the proposed

collaborative activities. Evidence of

continuing collaboration must be

submitted each year to ensure that the

relationships are still in place; and

b. Resolutions from the tribal councils

in support of their applications, if the

applicant is proposing to serve

American Indian/Alaskan Native tribal

entities.

H. Other Requirements

Technical Reporting Requirements

1. Provide CDC with the original and

two copies of semi-annual progress

reports.

2. Financial status report, no more

than 90 days after the end of the budget

period; and

3. Final financial and performance

reports, no more than 90 days after the

end of the project period.

Send all reports to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment I in the

application kit.

AR–1—Human Subjects Requirements

AR–2—Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR–7—Executive Order 12372 Review

AR–8—Public Health System Reporting

Requirements

AR–9—Paperwork Reduction Act

Requirements

AR–10—Smoke-Free Workplace

Requirements

AR–11—Healthy People 2010

AR–12—Lobbying Restrictions

AR–13—Prohibition on Use of CDC

Funds for Certain gun Control

Activities

AR–14—Accounting System

Requirements

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

section 393 and 394 of the Public Health

Service Act (42 U.S.C. 280b–1a and

280b–2) as amended and section 301(a)

of the Public Health Service Act (42

U.S.C. 241(a)). The Catalog of Federal

Domestic Assistance number is 93.136.

J. Where To Obtain Additional

Information

This and other CDC announcements

are available through the CDC homepage

on the Internet. The address for the CDC

homepage is http://www.cdc.gov.

To receive additional information and

to request an application kit, call 1–

888–GRANTS4 (1–888 472–6874). You

will be asked to leave your name and

address and will be instructed to

identify the Announcement number of

interest.

If you have questions after reviewing

the contents of all documents, business

management technical assistance may

be obtained from: Carrie Clark, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention, Room 3000,

2920 Brandywine Road, Atlanta, GA

30341–4146, Telephone number 770

488–2719, E-mail Address zri4@cdc.gov.

For program technical assistance,

contact: John Hemphill, Project Officer,

National Center for Injury Prevention

and Control, National Centers for

Disease Control and Prevention, 4770

Buford Highway, N.E.; MS K60, Atlanta,

GA.30341, 770 488–1285, E-mail

Address jdh2@cdc.gov.

24704 Federal Register / Vol. 65, No. 82 / Thursday, April 27, 2000 / Notices

Dated: April 21, 2000.

John L. Williams,

Director, Procurement and Grants Office

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–10487 Filed 4–26–00; 8:45 am]

BILLING CODE 4163–18–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1256]

Over-the-Counter Drug Products;

Public Hearing

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public hearing; request

for comments.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public hearing about the agency’s

approach to regulating over-the-counter

(OTC) drug products. The purpose of

the hearing is to solicit information

from, and the views of, interested

persons, including scientists,

professional groups, and consumers.

FDA intends to elicit comment on

general issues regarding the status of

OTC drug products, including the

criteria the agency should consider in

rendering decisions on OTC availability

of drugs, the classes of products, if any,

that are not currently available OTC that

should or should not be available OTC,

how FDA can be assured that consumers

understand the issues relating to OTC

availability of drug products, how

rational treatment decisions are affected

by coexisting prescription and OTC

therapies for a given disease, whether

the current structure for marketing OTC

products in the United States is

adequate, and FDA’s role in switching

products from prescription to OTC

status.

DATES: The public hearing will be held

on Wednesday, June 28, and Thursday,

June 29, 2000, from 8:30 a.m. to 4:30

p.m. Submit written notices of

participation and comments for

consideration at the hearing by June 2,

2000. Written comments will be

accepted after the hearing until August

25, 2000.

ADDRESSES: The public hearing will be

held at the Gaithersburg Holiday Inn, 2

Montgomery Village Ave., Gaithersburg,

MD 20879. Submit written notices of

participation to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852;

email: FDADockets@oc.fda.gov; or

through the Internet at http://

www.accessdata.fda.gov/scripts/oc/

dockets/meetings/meetingdocket.cfm.

Submit comments to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852;

email: FDADockets@oc.fda.gov; or

through the Internet at http://

www.accessdata.fda.gov/scripts/oc/

dockets/comments/commentdocket.cfm.

Transcripts of the hearing will be

available for review at the Dockets

Management Branch (address above)

and on the Internet at http://

www.fda.gov/ohrms/dockets.

FOR FURTHER INFORMATION CONTACT:

Patricia L. DeSantis, Center for Drug

Evaluation and Research (HFD–2), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

5400, e-mail: desantis@cder.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA regulates all prescription and

OTC drug products marketed in the

United States. Section 503(b) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 353(b)) describes the

criteria for determining whether a drug

product is subject to prescription

classification. Under section 503(b)(1) of

the act, a drug requires a prescription if:

(A) because of its toxicity or other

potentiality for harmful effect, or the method

of its use, or the collateral measures

necessary to its use, [it] is not safe for use

except under the supervision of a practitioner

licensed by law to administer such drug; or

(B) [it] is limited by an approved

application under section 505 [of the act] to

use under the professional supervision of a

practitioner licensed by law to administer

such drug.

All drug products not meeting the above

criteria may be sold OTC.

In 1972, FDA initiated rulemaking

procedures (the OTC Drug Review) to

determine which OTC drugs can be

generally recognized among qualified

experts as safe and effective and not

misbranded under prescribed,

recommended, or suggested conditions

of use. Through the OTC Drug Review,

FDA establishes monographs for classes

of OTC drug products (e.g., antacids,

skin protectants) that are found to be

generally recognized as safe and

effective and not misbranded when the

products contain the ingredients and are

labeled according to the monograph.

OTC drug monographs describe the

active ingredients, amount of drug,

formulation, labeling, and other general

requirements for drugs to be lawfully

sold OTC.

The regulations for the OTC Drug

Review are found in part 330 (21 CFR

part 330) and the monographs are in 21

CFR parts 331 through 358. The

regulations set forth standards for safety,

effectiveness, benefit-to-risk

considerations, and labeling of OTC

drug products.

The standards for safety,

effectiveness, and labeling for OTC

products are described in § 330.10(a)(4).

Safety for OTC use means a low

incidence of adverse reactions or

significant side effects under adequate

directions for use and warnings against

unsafe use, as well as low potential for

harm which may result from abuse

under conditions of widespread

availability. Effectiveness means a

reasonable expectation that, in a

significant proportion of the target

population, the pharmacological effect

of the drug, when used under adequate

directions for use and warnings against

unsafe use, will provide clinically

significant relief of the type claimed.

The benefit-to-risk ratio of a drug must

be considered in determining both

safety and effectiveness.

The labeling of OTC drug products

must be clear and truthful in all respects

and may not be false or misleading in

any particular. The labeling must state:

(1) The intended uses and results of

product use; (2) the adequate directions

for proper use; and (3) the warnings

against unsafe use, side effects, and

adverse reactions in terms that render

them likely to be read and understood

by the ordinary individual, including

individuals of low comprehension,

under customary conditions of purchase

and use (§ 330.10(a)(4)(v)).

During the course of the OTC Drug

Review, advisory review panels of

nongovernment experts evaluated the

various classes of OTC drug products

and recommended that a number of

drugs be switched from prescription to

OTC status. FDA acted on these

recommendations and switched a

number of products to OTC status,

including antihistamines (e.g.,

diphenhydramine hydrochloride (HCl),

doxylamine succinate), topical nasal

decongestants (e.g., oxymetazoline HCl,

xylometazoline HCl), topical

hydrocortisone, topical antifungals (e.g.,

haloprogin, miconazole nitrate), an

anthelmintic (pyrantel pamoate), an oral

anesthetic (dyclonine HCl), and various

fluoride dental rinses.

FDA has also approved the switch of

a number of drugs from prescription to

OTC status under new drug

applications. These include an

antidiarrheal (loperamide), topical

antifungals (e.g., clotrimazole,

terbinafine HCl), antihistamines (e.g.,