9710 Federal Register / Vol. 66, No. 28 / Friday, February 9, 2001 / Notices

In addition to the product listing

information required on Form FDA

2657, FDA may also require, under

§ 207.31, a copy of all advertisements

and a quantitative listing of all

ingredients for each listed drug or

biological product not subject to an

approved application or license; the

basis for a determination, by the

establishment, that a listed drug or

biological product is not subject to

marketing or licensing approval

requirements; and a list of certain drugs

or biological products containing a

particular ingredient. FDA may also

request, but not require, the submission

of a qualitative listing of the inactive

ingredients for all listed drugs or

biological products, and a quantitative

listing of the active ingredients for all

listed drugs or biological products

subject to an approved application or

license.

Under § 207.30, establishments must

update their product listing information

by using Form FDA 2657 and/or Form

FDA 2658 every June and December or,

at the discretion of the establishment,

when any change occurs. These updates

must include the following information:

(1) A listing of all drug or biological

products introduced for commercial

distribution that have not been included

in any previously submitted list, (2) all

drug or biological products formerly

listed for which commercial distribution

has been discontinued, (3) all drug or

biological products for which a notice of

discontinuance was submitted and for

which commercial distribution has been

resumed, and (4) any material change in

any information previously submitted.

No update is required if no changes

have occurred since the previously

submitted list.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

Reporting No. of

Respondents

No. of

Respones per

Respondent

Annual

Frequency

per Response

Total Annual

Responses

Hours per

Response

(1) Form FDA–2656 Registration of Drug Establishment

21 CFR 207.21, 207.22, 207.25, 207.26, and 207.40 15,802 .34 5,438 .5 2,719

(2) Form FDA–2656e Annual Update of Drug Establishment

21 CFR 207.21, 207.22, 207.25, 207.26, and 207.40 7,226 1 7,226 .5 3,613

(3) Form FDA–2657 Drug Product Listing

21 CFR 207.21, 207.22, 207.25, 207.30, 207.31,

and 207.40 14,381 2.80 40,270 .5 20,135

(4) Form FDA–2658 Registered Establishments’ Report of Private Label Distributors

21 CFR 207.21, 207.22, 207.25, 207.30, and 207.31 6,221 2.14 13,289 .5 6,645

Total Reporting Burden 33,112

1There are no capital costs or operating and maintenance costs associated with this collection of information.

In the Federal Register of November

2, 2000 (65 FR 65858), the agency

requested comments on the proposed

collections of information. The agency

received one comment on the 60-day

notice. The comment recommended that

FDA eliminate the requirement to send

a representative label and/or carton with

each Form FDA 2657 and 2658, and

that, instead, the labeling would be

available and submitted to FDA upon

request.

FDA appreciates the recommendation

concerning labeling submissions.

However, the comment is beyond the

scope of the November 2, 2000, notice.

That notice provided an opportunity for

public comment on the agency’s

estimates of the burden resulting from

the information collection requirements

imposed by part 207. In the Federal

Register of November 30, 2000 (65 FR

73798), FDA announced as part of the

semiannual regulatory agenda that it

intends to publish a proposed rule to

revise part 207 to clarify the

requirements for registration and listing

and to consolidate and reorganize the

regulations. The proposal would also

require the electronic submission of

establishment registration and product

listing information. It would be more

appropriate to submit the comment to

that proposed rule after it publishes in

the Federal Register.

Dated: February 5, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–3414 Filed 2–8–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1685]

New Food Chemicals Codex

Monographs, Revisions of Certain

Food Chemicals Codex Monographs, a

New General Test Procedure, and

Revisions to a Policy; Opportunity for

Public Comment; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

notice document that published in the

Federal Register of January 22, 2001 (66

FR 6624). The notice announced an

opportunity for public comment on

proposed new Food Chemicals Codex

specification monographs, proposed

changes to certain Food Chemicals

Codex specification monographs, a

proposed new general test procedure,

and proposed changes to a policy in the

fourth edition. The notice was

published with some inadvertent errors.

This document corrects those errors.

DATES: Submit written comments by

March 8, 2001. (The committee advises

that comments received after this date

may not be considered for the third

supplement to the fourth edition.

Comments received too late for

consideration for the third supplement

will be considered for later supplements

or for a new edition of the Food

Chemicals Codex.)

FOR FURTHER INFORMATION CONTACT: Paul

M. Kuznesof, Division of Product

Manufacture and Use (HFS–246), Office

of Premarket Approval, Center for Food

Safety and Applied Nutrition, Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3009.

Federal Register / Vol. 66, No. 28 / Friday, February 9, 2001 / Notices 9711

SUPPLEMENTARY INFORMATION: In FR Doc.

01–1713, appearing on page 6624 in the

Federal Register of January 22, 2001,

the following corrections are made:

1. On page 6625, in the first column,

in the last line of the first paragraph, the

Internet address is corrected to read

‘‘http://www.iom.edu/fcc.’’

2. On the same page beginning in the

same column, the formatting of all the

entries listed under I. Proposed New

Monographs and under II. Current

Monographs to Which the Committee

Proposes to Make Revisions is corrected

to read:

I. Proposed New Monographs

Flavor Chemicals

Acetaldehyde Diethyl Acetal

2-Acetyl Thiazole

Allyl Phenoxy Acetate

Allyl Propionate

Borneol

Butyl 2-Methyl Butyrate

2-sec-Butyl Cyclohexanone

Diphenyl Ether

d-Fenchone

Fenchyl Alcohol

Furfuryl Alcohol

2-Furyl Methyl Ketone

Salatrim

Soy Protein Concentrate

II. Current Monographs to Which the

Committee Proposes to Make Revisions

Ammonium Phosphate, Monobasic

(fluoride test corrected)

Carmine (description and assay test

revised)

Enzyme Preparations (classifications

and reactions added for αAcetolactatedecarboxylase;

Aminopeptidase, Leucine; and

Lysozyme) Flavor Chemicals

Cinnamic Acid (solubility in alcohol

revised)

d-Dihydrocarvone (solubility in alcohol

revised)

2-Heptanone (specific gravity revised)

Hexyl Isovalerate (solubility in alcohol

revised)

Isoamyl Benzoate (solubility in alcohol

revised)

Nerolidol (assay revised)

(Z)-6-Nonen-1-ol (refractive index

revised) alpha-Pinene (angular

rotation revised) 2-Undecenol

(specific gravity revised)

Potassium Phosphate, Monobasic

(fluoride test corrected)

Potassium Phosphate, Tribasic (fluoride

test corrected)

Potassium Pyrophosphate (fluoride test

corrected)

Potassium Tripolyphosphate (fluoride

test corrected)

Sodium Acid Pyrophosphate (fluoride

test corrected)

Sodium Metaphosphate, Insoluble

(fluoride test corrected)

Sodium Phosphate, Dibasic (fluoride

test corrected)

Sodium Phosphate, Monobasic (fluoride

test corrected)

Sodium Polyphosphate, Glassy (fluoride

test corrected)

Sodium Potassium Tripolyphosphate

(fluoride test corrected)

Sodium Trimetaphosphate (fluoride test

corrected)

Sodium Tripolyphosphate (fluoride test

corrected)

3. On page 6625, in the third column,

the last sentence is corrected to read:

‘‘Copies of the proposed changes may

also be obtained through the Internet at

http://www.iom.edu/fcc.’’

Dated: February 2, 2001.

L. Robert Lake,

Director of Regulations and Policy, Center

for Food Safety and Applied Nutrition.

[FR Doc. 01–3347 Filed 2–8–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1681]

Draft Guidance on Potassium Iodide as

a Thyroid Blocking Agent in Radiation

Emergencies; Availability; Extension

of Comment Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; extension of comment

period.

SUMMARY: The Food and Drug

Administration (FDA) is extending to

April 30, 2001, the comment period for

the draft guidance entitled ‘‘Potassium

Iodide as a Thyroid Blocking Agent in

Radiation Emergencies’’ that appeared

in the Federal Register of January 4,

2001 (66 FR 801). FDA is taking this

action in response to a request for an

extension.

DATES: Submit written comments on the

draft guidance by April 30, 2001.

General comments on agency guidance

documents are welcome at any time.

ADDRESSES: Copies of this draft

guidance are available on the Internet at

http://www.fda.gov/cder/guidance/

index.htm. Submit written requests for

single copies of the draft guidance to the

Drug Information Branch (HFD–210),

Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

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

office in processing your request.

Submit written comments to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. Requests and comments

should be identified with the docket

number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT: Rose

E. Cunningham, Executive Operations

(HFD–06), Center for Drug Evaluation

and Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–6779.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 4, 2001 (66

FR 801), FDA published a notice

announcing the availability of a draft

guidance document entitled ‘‘Potassium

Iodide as a Thyroid Blocking Agent in

Radiation Emergencies.’’ This draft

guidance updates the notice of

availability entitled ‘‘Potassium Iodide

as a Thyroid-Blocking Agent In a

Radiation Emergency: Final

Recommendations On Use,’’ published

in the Federal Register of June 29, 1982

(47 FR 28158). In this draft guidance,

FDA maintains its position that

potassium iodide is a safe and effective

means by which to prevent radioiodine

uptake by the thyroid gland, under

certain specified conditions of use, and

thus to lessen the risk of thyroid cancer

in the event of a radiation emergency.

FDA received an e-mail request, dated

January 4, 2001, requesting that the

agency extend the comment period on

the draft guidance by 60 days, allowing

90 days for comments. Because the draft

guidance introduces several new

recommendations, the agency has

decided to extend the comment period

on the draft guidance to April 30, 2001,

to allow the public more time to review

and comment on its contents.

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance document by April 30, 2001.

Two copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments should be

identified with the docket number

found in brackets in the heading of this

document. The draft guidance

document and received comments may

be seen in the Dockets Management

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

Monday through Friday.

Dated: February 2, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–3417 Filed 2–8–01; 8:45 am]

BILLING CODE 4160–01–F