62472 Federal Register / Vol. 60, No. 234 / Wednesday, December 6, 1995 / Notices

1This guidance does not apply to reprints of

articles that discuss the specific prohibited uses of

animal drugs listed in the FDA, Center for

Veterinary Medicine Compliance Policy Guide

7125.06 or the Animal Medicinal Drug Use

Clarification Act implementing regulations.

Although this guidance does not create or confer

any rights on any person and does not operate to

bind FDA in any way, it does represent the agency’s

current thinking on the dissemination of reprints of

certain published, original data. The agency will

consider individual circumstances on a case-bycase basis.

2Although this guidance does not create or confer

any rights, on any person, and does not operate to

bind FDA in any way, it does represent the agency’s

current thinking on industry funded dissemination

of reference texts. Although FDA believes that this

guidance encompasses the vast majority of

reference texts, the agency will consider, on a caseby-case basis, reference texts that do not fall within

the parameters of this guidance document. This

guidance does not apply to textbooks or compendia

that discuss the specific prohibited uses or animal

drugs listed in the Center for Veterinary Medicine

Compliance Policy Guide 7125.06 or the Animal

Medicinal Drug Use Clarification Act implementing

regulations.

3Printed materials, such as medical textbooks and

compendia, which supplement, explain, or are

textually related to a regulated product are

considered labeling for that product when

disseminated by or on behalf of the manufacturer,

packer, or distributor of the product. See section

201(m) of the act (21 U.S.C. 321(m)) and Kordel v.

United States, 338 U.S. 345, 350 (1948).

Guidance to Industry on Dissemination of

Reprints of Certain Published, Original

Data1

I. Purpose of Guidance

Sponsors frequently want to disseminate

reprints of articles reporting the results of the

effectiveness trials that have been relied on

by FDA in its approval or clearance of a drug,

device, or biologic product. However, such

articles may contain effectiveness rates, data,

analyses, uses, regimens, or other

information that is different from the

approved labeling, and might, if

disseminated by the sponsor, be considered

violative promotional activities.

Nonetheless, the agency intends to allow

the dissemination of reprints of articles that

represent the peer-reviewed, published

version of original efficacy trials, under the

circumstances described in section II. below.

II. Circumstances for Dissemination of

Certain Journal Articles Discussing FDAApproved Products

1. The principal subject of the article

should be the use(s) or indication(s) that has

been approved by FDA. The article should be

published in accordance with the regular

peer-review procedure of the journal in

which it is published, and the article reports

the original study that was represented by the

sponsor, submitted to FDA, and accepted by

the agency as one of the adequate and well

controlled studies providing evidence of

effectiveness. In the case of a medical device,

this guidance also applies to studies that

were otherwise represented by the sponsor,

submitted to the agency, and accepted by the

agency as valid and material evidence of

safety or effectiveness in lieu of adequate and

well controlled studies;

2. The reprint should be from a bona fide

peer-reviewed journal. A bona fide peerreviewed journal is a journal that utilizes

experts to review and objectively select,

reject, or provide comments about proposed

articles. Such experts should have

demonstrated expertise in the subject of the

article under review, and be independent

from the journal;

3. If the article contains effectiveness rates,

data, analyses, uses, regimens, or other

information that is different from approved

labeling, the reprint should prominently state

the difference(s), with specificity, on the face

of the reprint. One acceptable means of

achieving the appropriate prominence for

this statement is to permanently affix to the

reprint a sticker stating the differences; and

4. The reprint should disclose all material

Guidance for Industry Funded

Dissemination of Reference Texts2

I. Purpose of Guidance

Sponsors have also expressed a desire to

disseminate reference texts, i.e., medical

textbooks and compendia, to health care

professionals. These texts typically discuss a

wide range of medical diagnoses and

treatments, including drug product

utilization, surgical techniques, and other

medical topics. FDA recognizes that such

texts are often useful to clinicians in the

practice of medicine.

Reference texts often contain information

about the use of drugs, devices, or biologic

products in the treatment, diagnosis, or

prevention of disease that may not be

consistent with the FDA-approved labeling

for the products (e.g., discussion of

unapproved uses). FDA recognizes, however,

that many textbooks do not necessarily

highlight a particular drug or device

manufacturers products. In such instances,

industry’s desire to disseminate these

reference texts may be in conflict with the

Federal Food, Drug, and Cosmetic Act (the

act) and implementing regulations.3

Nonetheless, FDA intends to permit the

distribution of sound, authoritative materials

that are written, published, and disseminated

independent of the commercial interest of a

sponsoring company and are not false nor

misleading. FDA, therefore, intends to allow

the dissemination by sponsors of reference

texts that discuss human or animal drug,

device, or biologic products, under the

circumstances described in section II. below.

II. Circumstances for Dissemination of

Reference Textbooks

1. The reference text should not have been

written, edited, excerpted, or published

specifically for, or at the request of, a drug,

device, or biologic firm (see discussion

below);

2. The content of the reference text should

not have been reviewed, edited, or

significantly influenced by a drug, device, or

biologic firm, or agent thereof (see discussion

below);

3. The reference text should not be

distributed only or primarily through drug,

device, or biologic firms (e.g., it should be

other distribution channels where similar

books are normally available);

4. The reference text should not focus

primarily on any particular drug(s), device(s),

or biologic(s) of the disseminating company,

nor should it have a significant focus on

unapproved uses of the drug(s), device(s), or

biologic(s) marketed or under investigation

by the firm supporting the dissemination of

the text; and

5. Specific product information (other than

the approved package insert) should not be

physically appended to the reference text.

The agency recognizes that there are

some useful reference texts that are

written, edited, or published by a

sponsor or agent of the sponsor. In these

instances, FDA intends to allow the

distribution of a reference text under the

circumstances described in paragraphs 3

through 5 above, when the authorship,

editing, and publishing of the reference

text results in the presentation

of a balanced perspective of the subject

matter. Typically, this would be

evidenced by an authorship and

editorial process that fosters input from

a relatively wide spectrum of sources

and that allows for information from all

sources to be considered.

Dated: November 30, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–29663 Filed 12–1–95; 1:21 pm]

BILLING CODE 4160–01–F

National Institutes of Health

National Institute of Mental Health;

Notice of Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meetings of the National Institute of

Mental Health Special Emphasis Panel:

Agenda/Purpose: To review and evaluate

grant applications.

Committee Name: National Institute of

Mental Health Special Emphasis Panel

Date: December 5, 1995.

Time: 3 p.m.

Place: Parklawn Building, Room 9C–18,

5600 Fishers Lane, Rockville, MD 20857.

Contact Person: Phyllis L. Zusman,

Parklawn Building, Room 9C–18, 5600

Fishers Lane, Rockville, MD 20857,

Telephone: 301, 443–1340.

Committee Name: National Institute of

Mental Health Special Emphasis Panel

Date: December 11, 1995.

Time: 1:30 p.m.

Place: Parklawn Building, Room 9C–18,

5600 Fishers Lane, Rockville, MD 20857.

Contact Person: Michael D. Hirsch,

Parklawn Building, Room 9C–18, 5600

Fishers Lane, Rockville, MD 20857,

Telephone: 301, 443–1000.

Committee Name: National Institute of

Mental Health Special Emphasis Panel.
Federal Register / Vol. 60, No. 234 / Wednesday, December 6, 1995 / Notices 62473

Date: December 14, 1995.

Time: 1:30 p.m.

Place: Parklawn Building, Room 9C–18,

5600 Fishers Lane, Rockville, MD 20857.

Contact Person: Angela L. Redlingshafer,

Parklawn Building, Room 9C–18, 5600

Fishers Lane, Rockville, MD 20857,

Telephone: 301, 443–1367.

The meetings will be closed in

accordance with the provisions set forth

in secs. 552b(c)(4) and 552b(c)(6), Title

5, U.S.C. Applications and/or proposals

and the discussions could reveal

confidential trade secrets or commercial

property such as patentable material

and personal information concerning

individuals associated with the

applications and/or proposals, the

disclosure of which would constitute a

clearly unwarranted invasion of

personal privacy.

This notice is being published less

than fifteen days prior to the meetings

due to the urgent need to meet timing

limitations imposed by the review and

funding cycle.

(Catalog of Federal Domestic Assistance

Program Numbers 93.242, 93.281, 93.282)

Dated: December 4, 1995.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 95–29874 Filed 12–4–95; 1:41 pm]

BILLING CODE 4140–01–M

Division of Research Grants; Notice of

Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following Division

of Research Grants Special Emphasis

Panel (SEP) meetings:

Purpose/Agenda: To review individual

grant applications.

Name of SEP: Biological and Physiological

Services.

Date: December 13, 1995.

Time: 12:30 p.m.

Place: NIH, Rockledge 2, Room 5198,

Telephone Conference.

Contact Person: Dr. Peggy McCardle,

Scientific Review Administrator, 6701

Rockledge Drive, Room 5198, Bethesda,

Maryland 20892, (301) 435–1258.

This notice is being published less

than 15 days prior to the above meeting

due to the urgent need to meet timing

limitations imposed by the grant review

and funding cycle.

Name of SEP: Biological and Physiological

Sciences.

Date: December 20, 1995.

Time: 1:00 p.m.

Place: NIH, Rockledge 2, Room 4142,

Telephone Conference.

Contact Person: Dr. Edmund Copeland,

Scientific Review Administrator, 6701

Rockledge Drive, Room 4142, Bethesda,

Maryland 20892, (301) 435–1715.

The meetings will be closed in

accordance with the provisions set forth

in secs. 552b(c)(4) and 552b(c)(6), Title

5, U.S.C. Applications and/or proposals

and the discussions could reveal

confidential trade secrets or commercial

property such as patentable material

and personal information concerning

individuals associated with the

applications and/or proposals, the

disclosure of which would constitute a

clearly unwarranted invasion of

personal privacy.

(Catalog of Federal Domestic Assistance

Program Nos. 93.306, 93.333, 93.337, 93.393–

93.396, 93.837–93.844, 93.846–93.878,

93.892, 93.893, National Institutes of Health,

HHS)

Dated: December 4, 1995.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 95–29873 Filed 12–5–95; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF THE INTERIOR

Bureau of Land Management

[CA–066–96–1300–00; CACA–20139 and

CACA–22901]

Proposed Sand and Gravel Mining

Operation in Soledad Canyon, Los

Angeles County, CA

AGENCY: Bureau of Land Management,

Department of the Interior, Palm

Springs-South Coast Resource Area,

Desert District, California.

ACTION: Notice of Intent to prepare an

Environmental Impact Statement—

Second Notice.

SUMMARY: In compliance with the

National Environmental Policy Act

(NEPA) of 1969 and 40 CFR 1508.22,

notice is hereby given that the Bureau

of Land Management (BLM) will

prepare an Environmental Impact

Statement (EIS) for the Transit Mixed

Concrete (TMC) Surface Mining Project

(Project) proposed for construction and

operation in Soledad Canyon, Los

Angeles County, California. TMC

acquired the rights to develop the

Project through a competitive bid

process. The BLM granted the mineral

material contract to TMC in March

1990. The BLM complied with NEPA for

the sale of sand and gravel for the

Project site by preparing an

Environmental Assessment (EA) and

issuing a Finding of No Significant

Impact (FONSI) in 1989.

The Project plans to mine a total of 83

million tons of materials and sell

approximately 56 million tons of sand

and gravel, also known as Portland

cement concrete sand and gravel (PCC

aggregates), over a 20-year period to

fulfill contracts entered into with the

BLM.

The Project includes plans to operate

a concrete batch plant to produce and

deliver ready-mixed concrete to the

local market. All proposed mining and

operations will be located north of

Soledad Canyon Road and the Santa

Clara River. The 500-acre site represents

one of the westernmost reserves for PCC

aggregate production in the SaugusNewhall Production-Consumption

Region that is located outside the

floodplain of the Santa Clara River or a

tributary wash.

The general mining plan is to mine on

the south side of the ridge through a

series of four excavation cuts. Each cut

will progress from a higher elevation

and proceed downslope. Fill areas for

excess natural fines will be established

on both the south and north sides of the

ridge. Reclamation will be concurrent

with mining operations and measures

have been incorporated into Project

design to minimize erosion, provide

watershed control, and protect water

quality in the Santa Clara River. A full

range of alternatives to the proposed

action will be considered in the EIS.

SUPPLEMENTARY INFORMATION: The

Project site is on ‘‘split-estate’’ lands

where the surface is privately owned

and the minerals are federally owned

and administered by the BLM. The

project is subject to approval of a

Surface Mining Permit and

environmental analysis in accordance

with the California Environmental

Quality Act (CEQA). The County of Los

Angeles is the Lead Agency for

preparation of an Environmental Impact

Report (EIR) which will be prepared

separate from the EIS.

Comments from members of the

public are being requested to help

identify significant issues or concerns

related to the proposed action to

determine the scope of the issues and

alternatives that need to be analyzed,

and to identify and eliminate from

detailed study the issues that are not

significant. All comments

recommending that the EIS address

specific environmental issues should

contain supporting documentation and

rationale.

A Notice of Intent announcing BLM’s

intent to prepare an Environmental

Impact Statement for the proposed

project, was previously published in the

Federal Register October 16, 1995. The

public comment period closed

November 15, 1995. Per public request,