Federal Register / Vol. 60, No. 234 / Wednesday, December 6, 1995 / Notices 62469

which include the domestic policy directive issued

at that meeting, are available upon request to the

Board of Governors of the Federal Reserve System,

Washington, D.C. 20551. The minutes are published

in the Federal Reserve Bulletin and in the Board’s

annual report.

Federal Reserve Bank of New York as

follows:

The information reviewed at this

meeting suggests that economic activity

is expanding at a moderate rate in the

current quarter. Nonfarm payroll

employment increased considerably in

August after essentially no growth in

July; the civilian unemployment rate

edged down to 5.6 percent in August.

Industrial production posted a large

increase in August to a level moderately

above the average of the second quarter.

Total nominal retail sales rose slightly

on balance over July and August after

registering appreciable gains in the prior

two months. Housing starts were up a

little in August after increasing sharply

in July. Orders for nondefense capital

goods have softened but still point to

substantial expansion of spending on

business equipment over coming

months; nonresidential construction has

been strong of late The nominal deficit

on U.S. trade in goods and services

widened slightly in July from its average

rate in the second quarter. After

increasing at elevated rates in the early

part of the year, consumer and producer

prices have risen more slowly in recent

months.

Market interest rates have fallen

somewhat since the Committee meeting

on August 22. In foreign exchange

markets, the trade-weighted value of the

dollar in terms of the other G–10

currencies has declined over the

intermeeting period, with most of the

decline occurring over the past several

days.

M2 and M3 continued to register

sizable increases in August but growth

of those aggregates appears to have

moderated somewhat in September. For

the year through August, M2 expanded

at a rate somewhat below the upper end

of its range for 1995 and M3 grew at a

rate appreciably above its range. Total

domestic nonfinancial debt has grown at

a rate around the midpoint of its

monitoring range in recent months.

The Federal Open Market Committee

seeks monetary and financial conditions

that will foster price stability and

promote sustainable growth in output.

In furtherance of these objectives, the

Committee at its meeting in July

reaffirmed the range it had established

on January 31-February 1 for growth of

M2 of 1 to 5 percent, measured from the

fourth quarter of 1994 to the fourth

quarter of 1995. The Committee also

retained the monitoring range of 3 to 7

percent for the year that it had set for

growth of total domestic nonfinancial

debt. The Committee raised the 1995

range for M3 to 2 to 6 percent as a

technical adjustment to take account of

changing intermediation patterns. For

1996, the Committee established on a

tentative basis the same ranges as in

1995 for growth of the monetary

aggregates and debt, measured from the

fourth quarter of 1995 to the fourth

quarter of 1996. The behavior of the

monetary aggregates will continue to be

evaluated in the light of progress toward

price level stability, movements in their

velocities, and developments in the

economy and financial markets.

In the implementation of policy for

the immediate future, the Committee

seeks to maintain the existing degree of

pressure on reserve positions. In the

context of the Committee’s long-run

objectives for price stability and

sustainable economic growth, and

giving careful consideration to

economic, financial, and monetary

developments, slightly greater reserve

restraint or slightly lesser reserve

restraint would be acceptable in the

intermeeting period. The contemplated

reserve conditions are expected to be

consistent with growth in M2 and M3

over the balance of the year near the

pace of recent months.

By order of the Federal Open Market

Committee, November 27, 1995.

Donald L. Kohn,

Secretary, Federal Open Market Committee.

[FR Doc. 95–29696 Filed 12–5–95; 8:45 am]

BILLING CODE 6210–01–F–M

OFFICE OF GOVERNMENT ETHICS

Submission of Proposed Modified

Form for Executive Branch

Confidential Financial Disclosure

Reporting to OMB for Approval Under

the Paperwork Reduction Act

AGENCY: Office of Government Ethics

(OGE).

ACTION: Notice.

SUMMARY: The Office of Government

Ethics has submitted a proposed new

OGE Form 450 for confidential financial

disclosure reporting under its executive

branch regulations for approval by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act. This new form will replace the

existing Standard Form (SF) 450.

DATES: Comments on this proposal

should be received by January 5, 1996.

ADDRESSES: Comments should be sent to

Joseph F. Lackey, Office of Information

and Regulatory Affairs, Office of

Management and Budget, New

Executive Office Building, Room 10235,

Washington, DC 20503; telephone: 202–

395–7316.

FOR FURTHER INFORMATION CONTACT:

William E. Gressman, Office of the

General Counsel and Legal Policy,

Office of Government Ethics, 1201 New

York Avenue, NW., Washington, DC

20005–3917; telephone: 202–523–5757

(ext. 1110), FAX: 202–523–6325. A copy

of OGE’s draft form, as well as the rest

of OGE’s paperwork submission package

to OMB, may be obtained, without

charge, by contacting Mr. Gressman.

SUPPLEMENTARY INFORMATION: The Office

of Government Ethics is submitting a

proposed new OGE Form 450 Executive

Branch Confidential Financial

Disclosure Report for three-year

approval by OMB under the Paperwork

Reduction Act of 1995 (44 U.S.C.

chapter 35). On September 1, 1995, OGE

published an advance paperwork notice

of the proposed new OGE Form 450 (see

60 FR 45722–45723). During the public

comment period on that advance notice,

OGE received seven requests by persons

outside OGE for copies of the proposed

new form and two comment letters, both

of which were from Federal agencies

(the Nuclear Regulatory Commission

and the Defense Logistics Agency

(DLA)). The two comment letters

generally questioned certain aspects of

the confidential financial disclosure

system, including the underlying OGE

regulation codified at 5 CFR part 2634.

The comment letters also urged a few

specific changes to the wording or

concepts of the proposed form. Upon

review, OGE has determined not to

modify the underlying reporting format

nor the proposed form itself (except, as

to the form, for a couple of clarifying

revisions). In part in response to certain

DLA suggestions, the revisions to the

proposed form add references in the

instructions (on page 2) to the reporting

of ‘‘401k’’ plans and clarify that the

individual holdings of such plans as

well as Individual Retirement Accounts

and trusts must generally be reported.

The Office of Government Ethics’

reasons for not otherwise modifying

either the proposed form or the

underlying regulation follow.

The Office of Government Ethics has

already removed, by FR issuance, the

requirement for reporting of

Government securities, bank accounts

and certain similar items which do not

normally present much potential for a

conflict of interest. See below for a

discussion of this 1993 change, which is

not reflected in the existing SF 450, but

will be in the proposed OGE Form 450.

In addition, in the three years since the
62470 Federal Register / Vol. 60, No. 234 / Wednesday, December 6, 1995 / Notices

new executive branchwide confidential

disclosure system took effect in the fall

of 1992, the overall system has worked

well according to the agency feedback

that OGE has received. This is

particularly so since OGE and the

agencies have been flexible within the

regulatory framework, allowing for

appropriate limitations on coverage,

exceptions and alternative forms where

justified. Further, OGE is committed to

a future fundamental reassessment of

the basic structure of the confidential

disclosure system. For now, though, the

redesigned proposed OGE Form 450

represents urgently needed

improvements and updates to the

existing Standard Form 450 which it

will replace.

As noted, once finally approved by

OMB and adopted by OGE, the new

OGE form will replace the existing SF

450 Executive Branch Personnel

Confidential Financial Disclosure

Report. The SF 450 collects, as will the

future OGE Form 450, information

required under OGE’s executive

branchwide regulatory provisions. See

subpart I of 5 CFR part 2634. The new

OGE Form 450 will serve, as does the

current SF 450, as the uniform report

form for collection, on a confidential

basis, of financial information required

by the OGE regulation from certain new

entrant and incumbent employees of the

executive branch departments and

agencies in order to allow ethics

officials to conduct conflict of interest

reviews and to resolve any actual or

potential conflicts found.

The basis for the OGE regulation and

the report form is two-fold. First, section

201(d) of Executive Order 12674 of

April 12, 1989 (as modified by

Executive Order 12731 of October 17,

1990) makes OGE responsible for the

establishment of a system of nonpublic

(confidential) financial disclosure by

executive branch employees to

complement the system of public

disclosure under the Ethics in

Government Act of 1978 (the ‘‘Ethics

Act’’), as amended, 5 U.S.C. appendix.

Second, section 107(a) of the Ethics Act

further provides authority for OGE as

the supervising ethics office for the

executive branch of the Federal

Government to require that appropriate

executive agency employees file

confidential financial disclosure reports,

‘‘in such form as the supervising ethics

office may prescribe.’’ The current SF

450, together with the underlying OGE

confidential disclosure regulation, both

initially adopted in 1992 after

appropriate clearances from OMB as

well as the General Services

Administration (GSA) for the standard

form, constitute the form OGE has

prescribed for such confidential

financial disclosure in the executive

branch. The Office of Government

Ethics recently sought and subsequently

obtained a limited paperwork renewal

from OMB as to the existing SF 450 in

order to allow sufficient time for OGE to

develop and clear the new OGE Form

450 which is the subject of this notice.

See 60 FR 34258–34259 (June 30, 1995).

The new OGE form will not require GSA

clearance, since it is not a standard (or

optional) form under the GSA program.

The Office of Government Ethics will

provide further information in the

future to the agencies and the public

about the details of phasing in the new

form, once it is finally cleared and

adopted, and phasing out the existing

standard form.

Since the OGE’s financial disclosure

regulation at 5 CFR part 2634 and the

reporting format were adopted in 1992,

there have been certain revisions to

each. The most significant of these is the

determination of OGE to exclude from

general executive branch confidential

financial disclosure the reporting of

cash accounts in depository institutions

(including banks), money market

mutual funds and accounts and U.S.

Government obligations and securities.

See 58 FR 63023–63024 (November 30,

1993). The Office of Government Ethics

has directed executive departments and

agencies to notify all filers of this

change, which is not reflected on the SF

450 itself. The new OGE replacement

form will reflect that change, as well as

various other changes and

improvements in the reporting format,

to make it clearer and more userfriendly. A more complete set of

instructions for filling out the form is

included in the draft OGE Form 450 and

helpful examples are set forth on the

reporting parts.

The Office of Government Ethics

expects that the new form should be

ready, after OMB clearance, for

dissemination to executive branch

departments and agencies early next

year. As noted above, the Office of

Government Ethics will provide

appropriate guidance and phase-in time

to departments and agencies once the

new form is available. The new form

will be made available in paper, on

electronic disk and on OGE’s electronic

bulletin board entitled ‘‘The Ethics

Bulletin Board System’’ (TEBBS). In

addition, OGE will work on making

available a future electronic version of

the form, to allow employees the option

of preparing it on a computer. The

Office of Government Ethics also

intends to permit departments and

agencies to develop or utilize electronic

versions of the form on their own,

provided that they precisely duplicate

the paper original to the extent possible.

Since 1992, various agencies have

developed, with OGE review/approval,

alternative reporting formats, such as

certificates of no conflict, for certain

classes of employees. Other agencies

provide for additional disclosures

pursuant to independent organic

statutes and in certain other

circumstances when authorized by OGE.

However, the future OGE Form 450, as

successor to the current SF 450, will

remain the uniform executive branch

report form for most of those executive

branch employees who are required by

their agencies to report confidentially

on their financial interests. The

confidential report form is to be filed by

each reporting individual with the

designated agency ethics official at the

executive department or agency where

he or she is or will be employed.

Reporting individuals are regular

employees whose positions have been

designated by their agency as requiring

confidential financial disclosure in

order to help avoid conflicts with their

assigned responsibilities; additionally,

all special Government employees

(SGEs) are generally required to file.

Agencies may, if appropriate under the

OGE regulation, exclude certain regular

employees or SGEs as provided in 5

CFR 2634.905. Reports are normally

required to be filed within 30 days of

entering a covered position (or earlier if

required by the agency concerned), and

again annually if the employee serves

for more than 60 days in the position.

As indicated in § 2634.907 of the OGE

regulation, the information required to

be collected includes assets and sources

of income, gifts and travel

reimbursements, liabilities, employment

agreements and arrangements, and

outside positions, subject to certain

thresholds and exclusions.

Most of the persons who file this

report form are current executive branch

Government employees at the time they

complete the forms. However, some

filers are private citizens who are asked

by their prospective agency to file a new

entrant report prior to entering

Government service in order to permit

advance checking for any potential

conflicts of interest and resolution

thereof by agreement to recuse, divest,

obtain a waiver, or take other remedial

steps. Based on OGE’s annual agency

ethics questionnaire responses,

approximately 285,000 SF 450 report

forms were filed during 1994

throughout the executive branch. Of

these, OGE estimates that no more than

between 5% and 10%, or some 14,250

to 28,500 per year, are filed by private

citizens whose agencies require that
Federal Register / Vol. 60, No. 234 / Wednesday, December 6, 1995 / Notices 62471

they file their new entrant reports prior

to assuming Government

responsibilities.

Each filing is estimated to take an

average of one and one-half hours. The

number of private citizens whose

reports are filed each year with OGE is

less than 10, but pursuant to 5 CFR

1320.3(c)(4)(i), the lower limit for this

general regulatory-based requirement is

set at 10 private persons (OGEprocessed reports). This yields an

annual reporting burden of 15 hours, the

same as in the current OMB inventory

for this information collection. The

remainder of the private citizen reports

are filed with other departments and

agencies throughout the executive

branch.

Public comment is again invited on

each aspect of the proposed new OGE

Form 450 as set forth in this second

notice, including specifically views on

the need for and practical utility of this

proposed modified collection of

information, the accuracy of OGE’s

burden estimate, the enhancement of

quality, utility and clarity of the

information collected, and the

minimization of burden (including the

use of information technology). The

Office of Government Ethics, in

consultation with OMB, will consider

all comments received, which will

become a matter of public record.

Approved: November 30, 1995.

Donald E. Campbell,

Deputy Director, Office of Government Ethics.

[FR Doc. 95–29723 Filed 12–5–95; 8:45 am]

BILLING CODE 6345–01–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95D–0377]

Advertising and Promotion; Draft

Guidances

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is publishing two

draft guidance documents entitled

‘‘Guidance to Industry on Dissemination

of Reprints of Certain Published,

Original Data’’ and ‘‘Guidance for

Industry Funded Dissemination of

Reference Texts.’’ These draft guidances

are related to the dissemination, by

sponsors of human and animal drugs,

medical devices, and biological

products, of certain reprints of journal

articles discussing FDA-approved

products, and reference texts (medical

textbooks and compendia). The draft

guidances describe circumstances under

which the agency would exercise its

discretion to allow the dissemination of

these reprints and reference texts to

health care professionals.

DATES: Written comments by January 5,

1996.

ADDRESSES: Submit written comments

on the draft guidance documents to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857, or FAX at 301–

594–3215.

FOR FURTHER INFORMATION CONTACT: Ilisa

B. G. Bernstein, Office of Policy (HF–

23), Food and Drug Administration,

5600 Fishers Lane, rm. 15–74, Rockville,

MD 20857, 301–827–3380, or via

internet at IBernste@bangate.fda.gov.

SUPPLEMENTARY INFORMATION: Health

care professionals have always been

able to obtain, from a number of

different sources, journal articles and

reference texts (i.e., medical textbooks

and compendia), that discuss human

and animal drugs, medical devices, and

biological products. These journal

articles and reference texts are

commercially available and may be

obtained from publishers, libraries, online data bases, colleagues, bookstores,

companies upon request, or other

sources. Sponsors of human and animal

drugs, medical devices, and biological

products frequently have expressed a

desire to disseminate reprints of journal

articles and reference texts to health

care professionals.

FDA traditionally has taken the

position that sponsors who wish to

distribute articles and reference texts

containing information that is

inconsistent with the FDA-approved

labeling for a product may be in conflict

with the Federal Food, Drug, and

Cosmetic Act and implementing

regulations. The agency’s position is

based on its mission to help ensure the

safety and efficacy of human and animal

drugs, medical devices, and biological

products. Sponsors seeking approval or

clearance to market these products must

demonstrate to FDA that the products

are safe and effective for their intended

use(s). Permitting sponsors to freely

disseminate information that is

inconsistent with the FDA-approved or

cleared use(s) would diminish the

incentive for sponsors to perform the

clinical studies which are necessary to

verify that the product is safe and

effective for the unapproved use.

Furthermore, information disseminated

by a biased source may have a greater

potential to mislead the health care

professional.

FDA believes that journal articles and

reference texts are often useful to health

care professionals. Accordingly, the

agency has reviewed its policies to

determine if modifications can be made

without jeopardizing the integrity of the

statutorily mandated standard that

marketed drugs be safe and effective and

have adequate directions for their

intended use(s). After careful review,

the agency is proposing to modify two

of its policies at this time.

First, under one proposed draft

guidance, the agency would allow

sponsors to disseminate, under certain

circumstances, journal articles that

report the results of well-controlled

studies, provided they represent the

peer-reviewed, published version of

original efficacy trials used to support

approval, licensure, or clearance.

Second, under the other proposed draft

guidance, the agency would allow

sponsors to disseminate, under certain

circumstances, reference texts that

discuss human or animal drugs, medical

devices, or biological products. FDA has

prepared two draft guidance documents

describing the proposed circumstances

under which the agency would exercise

its discretion regarding the

dissemination of these materials by

sponsors.

FDA is particularly interested in

receiving comments on whether the

reprints discussed in the ‘‘Guidance to

Industry on Dissemination of Reprints

of Certain Published, Original Data’’

should be from ‘‘peer-reviewed’’

journals. If so, please comment on what

constitutes a ‘‘peer-reviewed’’ journal

and what benefits would be afforded if

these reprints are from ‘‘peer-reviewed’’

journals.

Interested persons may, on or before

January 5, 1996, submit to the Dockets

Management Branch (address and FAX

number above) written comments on the

draft guidance documents. 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. The draft guidance

documents and received comments are

available for public examination in the

office above between 9 a.m. and 4 p.m.,

Monday through Friday.

The texts of the draft guidance

documents follow: