Federal Register / Vol. 62, No. 60 / Friday, March 28, 1997 / Notices 14911

Dated: March 20, 1997.

Ida M. Ustad,

Deputy Associate Administrator, Office of

Acquisition Policy.

[FR Doc. 97–7939 Filed 3–27–97; 8:45 am]

BILLING CODE 6820–61–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0026]

New Monographs and Revisions of

Certain Food Chemicals Codex

Monographs; Opportunity for Public

Comment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on

pending changes to certain Food

Chemicals Codex specification

monographs in the fourth edition and

on proposed new specification

monographs. New monographs for

certain substances used as food

ingredients and additions, revisions,

and corrections to current monographs

are being prepared by the National

Academy of Sciences/Institute of

Medicine (NAS/IOM) Committee on

Food Chemicals Codex (the committee).

This material is expected to be

presented in the next publication of the

Food Chemicals Codex (the first

supplement to the fourth edition),

scheduled for publication in late

summer 1997.

DATES: Written comments by May 12,

1997. (The committee advises that

comments received after this date may

not be considered for the first

supplement to the fourth edition.

Comments received too late for

consideration for the first supplement

will be considered for later

supplements.)

ADDRESSES: Submit written comments

and supporting data and documentation

to the NAS/IOM Committee on Food

Chemicals Codex, National Academy of

Sciences, 2101 Constitution Ave. NW.,

Washington, DC 20418. Copies of the

new monographs and proposed

revisions to current monographs may be

obtained upon written request from

NAS (address above) or may be

examined at the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

Requests for copies should specify the

monographs desired by name. New and

revised monographs may also be

obtained through the Internet at http://

www2.nas.edu/codex.

FOR FURTHER INFORMATION CONTACT:

Fatima N. Johnson, Committee on Food

Chemicals Codex, Food and Nutrition

Board, National Academy of Sciences,

2101 Constitution Ave. NW.,

Washington, DC 20418, 202–334–2580;

or Paul M. Kuznesof, Center for Food

Safety and Applied Nutrition (HFS–

247), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3009.

SUPPLEMENTARY INFORMATION: By

contract with NAS/IOM, FDA supports

the preparation of the Food Chemicals

Codex, a compendium of specification

monographs for substances used as food

ingredients. Before any specifications

are included in a Food Chemicals Codex

publication, public announcement is

made in the Federal Register. All

interested parties are invited to

comment and to make suggestions for

consideration. Suggestions should be

accompanied by supporting data or

other documentation to facilitate and

expedite review by the committee.

In the Federal Register of December 3,

1996 (61 FR 64098), FDA last

announced that the committee was

considering additional new monographs

and a number of monograph revisions

for inclusion in the first supplement to

the fourth edition of the Food Chemicals

Codex, which is scheduled for

publication in late summer, 1997. The

fourth edition of the Food Chemicals

Codex was released by the National

Academy Press (NAP) in March 1996. It

is now available for sale from NAP (1–

800–624–6242; 202–334–3313; FAX

202–334–2451; Internet http://

www.nap.edu) 2101 Constitution Ave.

NW., Lockbox 285, Washington, DC

20055.

FDA now gives notice that the

committee is soliciting comments and

information on additional proposed new

monographs and proposed changes to

certain current monographs. These new

monographs and changes are also

expected to be published in the first

supplement to the fourth edition of the

Food Chemicals Codex. Copies of the

proposed new monographs and

revisions to current monographs may be

obtained upon written request from

NAS at the address listed above or

through the internet at http://

www2.nas.edu/codex.

FDA emphasizes, however, that it will

not consider adopting and incorporating

any of the committee’s new monographs

or monograph revisions into FDA

regulations without ample opportunity

for public comment. If FDA decides to

propose the adoption of new

monographs and changes that have

received final approval of the

committee, it will announce its

intention and provide an opportunity

for public comment in the Federal

Register.

The committee invites comments and

suggestions by all interested parties on

specifications to be included in the

proposed new monographs (3) and

revisions of current monographs (8)

listed below:

I. Proposed New Monographs

Manganese Citrate

Olestra

Vitamin K

II. Current Monographs to Which the

Committee Proposes to Make Revisions

Acid Hydrolysates of Proteins (add new

limit tests for 3-chloropropane-1,2-

diol and 1,3- dichloro-2-propanol;

correct limit tests for potassium and

sodium)

Calcium Chloride (change description)

Calcium Chloride Solution (reduce lead

limit)

Glycerol Ester of Partially Dimerized

Rosin (change softening point test

procedure)

Hydroxylated Lecithin (reduce heavy

metals and lead limits)

Iron, Reduced (revise arsenic

specification)

Lecithin (change description, add

labeling requirement, increase acid

value limit, reduce heavy metals

and lead limits, and revise peroxide

value limit for enzyme-modified

material)

Phosphoric Acid (increase heavy metals

limit, add lead requirement)

Interested persons may, on or before

May 12, 1997, submit to NAS written

comments regarding the monographs

listed in this notice. Timely submission

will ensure that comments are

considered for the first supplement to

the fourth edition of the Food Chemicals

Codex. Comments received after this

date may not be considered for the first

supplement, but will be considered for

subsequent supplements. Those wishing

to make comments are encouraged to

submit supporting data and

documentation with their comments.

Two copies of any comments regarding

the monographs listed in this notice are

to be submitted to NAS (address above).

Comments and supporting data or

documentation are to be identified with

the docket number found in brackets in

the heading of this document and each

submission should include the

statement that it is in response to this

Federal Register notice. NAS will
14912 Federal Register / Vol. 62, No. 60 / Friday, March 28, 1997 / Notices

forward a copy of each comment to the

Dockets Management Branch (address

above). Received comments may be seen

in the Dockets Management Branch

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

through Friday.

Dated: March 20, 1997.

Fred R. Shank,

Director, Center for Food Safety and Applied

Nutrition.

[FR Doc. 97–7836 Filed 3–27–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95P–0110]

Prescription Drug Advertising and

Promotional Labeling; Development

and Use of FDA Guidance Documents;

Request for Comments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; request for comments.

SUMMARY: As part of ongoing efforts

initiated by the Food and Drug

Administration (FDA) in March 1996 to

ensure meaningful public participation

in the guidance document development

process, FDA’s Division of Drug

Marketing, Advertising, and

Communications (DDMAC) is

requesting public comment on guidance

documents relating to prescription drug

advertising and labeling. DDMAC has

identified three general types of

guidance documents on which it is

seeking public comment. Specifically,

DDMAC is requesting public comment

on the rescission of guidances identified

by DDMAC as obsolete, the revision and

reissuance of DDMAC guidances that

address current issues, and currently

proposed guidance documents and

suggestions of topics for new guidances

that DDMAC may develop.

DATES: Written comments by June 26,

1997.

ADDRESSES: Submit written requests for

copies of the guidances under review by

DDMAC to the Freedom of Information

Staff (HFI–35), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857. Submit written

comments on the guidances or related

issues to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. Two

copies of any comments are to be

submitted, except that individuals may

submit one. Comments should be

identified with the docket number

found in brackets in the heading of this

document. Copies of the guidances

under review by DDMAC are available

for public examination in the Dockets

Management Branch (address above)

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

through Friday.

FOR FURTHER INFORMATION CONTACT:

Melissa M. Moncavage, Center for Drug

Evaluation and Research (HFD–40),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2828, e–mail:

‘‘moncavage@cder.fda.gov.’’

SUPPLEMENTARY INFORMATION: Issues

relating to FDA’s development and

issuance of guidance documents were

raised in a citizen petition submitted by

the Indiana Medical Devices

Manufacturers Council, Inc. (IMDMC)

(see Docket No. 95P–0110). The IMDMC

petition requested that FDA control the

initiation, development, and issuance of

guidance documents by written

procedures that ensure the appropriate

level of meaningful public participation.

In response to the petition, FDA agreed

to take steps to improve the agency’s

guidance document procedures.

In the Federal Register of March 7,

1996 (61 FR 9181), FDA published a

notice that set forth its proposal on how

best to improve its guidance document

procedures and solicited comment on

these and additional ideas for

improvement (March 1996 notice). On

April 26, 1996, the agency held a public

meeting to discuss these issues further.

The comment period for the March 7

notice closed on June 5, 1996. In the

Federal Register of February 27, 1997

(62 FR 8961), FDA published a notice

explaining how the agency will proceed

in the future with guidance document

development, issuance, and use. The

notice included the agency document

entitled ‘‘Good Guidance Practices’’ (the

GGP’s document), which sets forth the

agency’s policies and procedures for

developing, issuing, and using guidance

documents.

In the GGP’s document, the agency

defines ‘‘guidance documents’’ to

include documents prepared for FDA

staff, applicants and sponsors, and the

public that: (1) Relate to the processing,

content, and evaluation and approval of

submissions; (2) relate to the design,

production, manufacturing, and testing

of regulated products; (3) describe the

agency’s policy and regulatory approach

to an issue; or (4) establish inspection

and enforcement policies and

procedures. ‘‘Guidance documents’’ do

not include documents relating to

internal FDA procedures, agency

reports, general information documents

provided to consumers, speeches,

journal articles and editorials, media

interviews, press materials, warning

letters, or other communications

directed to individual persons or firms.

Guidance documents do not create or

confer any rights for or on any person

and do not operate to bind FDA or the

public. Rather, they explain the agency’s

current thinking on a certain subject.

However, a company affected by a

guidance may use an alternative

approach if the alternative approach

satisfies the requirements of the

applicable statute, regulations, or both.

A guidance document cannot itself be

the basis for an enforcement action.

FDA has adopted a two-level

approach to the development of

guidance documents. The procedures

for developing a guidance document

will depend on whether that guidance

document is a ‘‘level 1’’ guidance or a

‘‘level 2’’ guidance. Level 1 guidance

documents generally include guidance

that sets forth first interpretations of

statutory or regulatory requirements,

changes in interpretation or policy that

are of more than a minor nature,

unusually complex scientific issues, or

highly controversial issues. Level 1

guidance documents are directed

primarily to applicants or sponsors or

other members of the regulated

industry. Level 2 guidance documents

include all other guidance documents.

In general, the agency will solicit public

comment during the development of

level 1 guidance documents. For level 2

guidance documents, the agency may

choose to solicit comment before

implementing a guidance, but in general

an opportunity for public comment will

be provided upon issuance of the

guidance document. (See FDA GGP’s.)

The agency also is making efforts to

keep the public up to date on the status

of agency guidance development and to

provide the public an opportunity to

suggest possible topics for document

development or revision.

DDMAC guidances on achieving

compliance with the prescription drug

advertising and labeling statutes and

regulations have been issued to the

pharmaceutical industry since 1970 in

various forms, often as letters or

guidance papers. As a result of FDA’s

GGP effort, DDMAC has decided to

reissue its guidance documents in a

standardized format and grouped by

common topic, such as content, format,

class of drugs, or how to interact with

DDMAC. To that end, DDMAC is

undertaking a review of all such

guidances to determine the following:

(1) Which guidances are obsolete; (2)

which guidances address current issues,

but may need revision; and (3) whether

there are new topics on which DDMAC

should develop guidance documents.

Once the guidance review process is

completed, new and reissued DDMAC

guidances will be made available, in