4252 Federal Register / Vol. 65, No. 17 / Wednesday, January 26, 2000 / Notices

The estimated burden for § 803.19 is

further adjusted to reflect the agency’s

actual experience with this type of

submission.

Prior to the program change reflected

in this rule, § 803.22(b)(2) provided that,

if a manufacturer erroneously receives

information about an adverse event

concerning a device that they had not

manufactured, the manufacturer must

submit the report to FDA along with a

cover letter explaining that the device in

question was not manufactured by that

firm. This final rule amends

§ 803.22(b)(2) to apply the same

requirement to importers. The

requirements of § 803.22(b)(2) were not

previously reviewed by OMB under the

PRA. Thus, the estimated burden

reflects FDA’s experience with this

provision with regard to manufacturers

and includes the estimated burden for

both manufacturers and importers.

Prior to the program change reflected

in this rule, § 803.33 required medical

device user facilities to submit summary

reports semiannually. Under this rule,

user facilities are required to submit

summary reports annually, thereby

significantly decreasing the reporting

burden on user facilities. The estimated

burden for this section is also adjusted

to reflect the agency’s actual experience

with this type of submission. FDA Form

3419 is being revised to reflect this

change.

Under this rule the reporting

requirement for importers of medical

devices previously codified under

§ 804.25 is being transferred to § 803.40.

The estimated burden for importer

reporting is based upon the agency’s

actual experience with this type of

submission. Section 803.40 requires

importers to submit reports within 30

days after learning of the reportable

event rather than 10 days as provided in

§ 804.25; this change does not affect the

burden.

This rule does not amend § 803.55,

but FDA is seeking approval for FDA

Form 3417 on which baseline reports

are to be submitted. The agency’s

estimate is based on FDA’s actual

experience with this type of submission.

Prior to the program change reflected

in this rule, § 803.57 required medical

device manufacturers to annually certify

as to the number of reports submitted

during the previous year, or that no

such reports had been submitted.

Distributors (including importers) were

required to certify under § 804.30. As

stated previously, FDA is also

exempting manufacturers and

distributors of cigarettes and smokeless

tobacco products from the requirement

of annual certification. Therefore, under

this rule, §§ 803.57 and 804.30 are being

eliminated.

Because distributors, including

distributors of cigarettes and smokeless

tobacco products, will no longer be

required to report, the final rule also

removes §§ 804.25 (distributor

reporting), 804.32 (supplemental

information), and 804.33 (alternative

reporting requirements).

II. Recordkeeping Requirements

Prior to the program change reflected

in this rule, § 803.17 required

manufacturers and user facilities to

establish written procedures for

employee education, complaint

processing, and documentation of

information related to MDR’s. Under

this rule, the requirements for

establishing written MDR procedures for

importers of medical devices have been

transferred to § 803.17. The agency

believes that the majority of

manufacturers, user facilities, and

importers have already established

written procedures to document

complaints and information related to

MDR reporting as part of their internal

quality control system. The agency has

estimated that no more than 2,000 such

entities would be required to establish

new procedures, or revise existing

procedures, in order to comply with this

provision. For those entities, a one-time

burden of 10 hours, annualized over a

period of 5 years, is estimated for

establishing written MDR procedures.

The remainder of manufacturers, user

facilities, and importers not required to

revise their written procedures to

comply with this provision are excluded

from the burden because the

recordkeeping activities needed to

comply with this provision are

considered ‘‘usual and customary’’

under 5 CFR 1320.3(b)(2).

Prior to the program change reflected

in this rule, § 803.18 required

manufacturers and user facilities to

establish and maintain MDR event files.

Distributors (including importers) were

required to establish and maintain MDR

event files under § 804.35. Under this

rule, § 803.18 is modified to transfer the

recordkeeping requirements for

importers and other distributors of

medical devices, including cigarettes

and smokeless tobacco products from

§ 804.35; therefore, § 804.35 is removed.

As discussed previously, this

recordkeeping may be done in an

electronic format.

Under the proposed rule, distributors

of cigarettes and smokeless tobacco

products would have been required to

establish written internal procedures for

evaluating and reporting events.

Because distributors of cigarettes and

smokeless tobacco products will not be

required to report under the final rule,

§ 804.34 is removed.

Dated: January 18, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–1786 Filed 1–25–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 91N–0101, 91N–0098, 91N–

0103, and 91N–100H]

Food Labeling; Health Claims and

Label Statements; Request for

Scientific Data and Information;

Reopening of Comment Period

Editorial Note: Due to a printing error FR

Document 00–1127 did not appear in the

printed version of the Federal Register on

Wednesday, January 19, 2000. It is printed in

its entirety below.

AGENCY: Food and Drug Administration,

HHS.

ACTION: Request for written comments;

reopening of comment period.

SUMMARY: The Food and Drug

Administration (FDA) is reopening for

75 days the comment period for the

submission of scientific data, research

study results, and other related

information on four substance-disease

relationships that was announced in the

Federal Register of September 8, 1999

(64 FR 48841). This action is being

taken in response to requests for more

time to submit data and information to

FDA.

DATES: Written comments by April 3,

2000.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration (HFA–305), Food and

Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Christine J. Lewis, Center for Food

Safety and Applied Nutrition (HFS–

451), Food and Drug Administration,

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

202–205–4168.

SUPPLEMENTARY INFORMATION: In the

Federal Register of September 8, 1999

(64 FR 48841), FDA requested scientific

data, research study results, and other

related information on four substancedisease relationships in order to

reevaluate the scientific evidence for

these relationships. FDA stated that it

was taking this action to comply with a

Federal Register / Vol. 65, No. 17 / Wednesday, January 26, 2000 / Notices 4253

recent court decision in which FDA was

instructed to reconsider whether to

authorize health claims for these

relationships in dietary supplement

labeling. The four health claims are:

‘‘Consumption of antioxidant vitamins

may reduce the risk of certain kinds of

cancer,’’ ‘‘Consumption of fiber may

reduce the risk of colorectal cancer,’’

‘‘Consumption of omega-3 fatty acids

may reduce the risk of coronary heart

disease,’’ and ‘‘0.8 mg of folic acid in a

dietary supplement is more effective in

reducing the risk of neural tube defects

than a lower amount in foods in

common form.’’ The agency stated that

it will use the data and information to

determine, for each substance-disease

relationship, if an appropriate scientific

basis exists to support the issuance of a

proposed rule to authorize a health

claim for the relationship.

The agency received requests to

reopen the comment period on the

September 8, 1999, notice to allow

interested persons to comment after

reviewing FDA’s guidance on the

‘‘significant scientific agreement’’

standard for health claims in 21 U.S.C.

343(r)(3)(B)(i) and 21 CFR 101.14(c).

The availability of that guidance was

announced on December 22, 1999 (64

FR 71794). The agency has agreed to

reopen the comment period on the

September 8, 1999, notice for 75 days in

response to the requests.

The agency has established four

dockets to compile information relating

to each of the four topic areas; docket

numbers are specified in Table 1 below.

FDA is allowing 75 days for the

submission of additional data.

Individuals and organizations

submitting information or data relating

to a specific topic should submit two

copies of the information to the Dockets

Management Branch (address above) by

April 3, 2000. Separate submissions

should be made for each topic area, and

each submission should be identified

with the appropriate docket number

given below. Submissions received may

be seen in the Dockets Management

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

Monday through Friday.

Scientific data, research study results,

and other related information on four

substance-disease relationships that is

submitted to the FDA must be

considered publicly available. If used in

the agency’s scientific review,

information submitted to FDA will

become part of the public record for the

evaluation of these relationships.

TABLE 1.

Topic Docket No.

Antioxidant vitamins and cancer 91N–0101

Fiber and colorectal cancer 91N–0098

Omega-3 fatty acids and coronary heart disease 91N–0103

Folic acid (dietary supplement vs. food form) and neural tube defects 91N–100H

Dated: January 11, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–1127 Filed 1–18–00; 8:45 am]

BILLING CODE 4160–01–F

Editorial Note: Due to a printing error FR

Document 00–1127 did not appear in the

printed version of the Federal Register on

Wednesday, January 19, 2000. It is printed in

its entirety above.

[FR Doc. 00–1127 Filed 1–25–00; 8:45 am]

BILLING CODE 1505–01–D

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 79N–0113; DESI 2847]

Pediatric Parenteral Multivitamin

Products; Drug Efficacy Study

Implementation; Announcement of

Marketing Conditions

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that pediatric parenteral multivitamin

drug products that are formulated as set

forth in this document are effective for

treating certain vitamin deficiencies.

FDA is further announcing the

conditions for the approval and

marketing of the drug products for the

indications for which they are now

regarded as effective.

DATES: Supplements to the

conditionally approved new drug

application (NDA) must be submitted by

March 27, 2000.

ADDRESSES: Communication in response

to this notice should be identified with

the reference number DESI 2847 and

directed to the attention of the

appropriate office named below.

Supplements to the conditionally

approved NDA (identify with NDA

number): Division of Metabolic and

Endocrine Drug Products (HFD–510),

Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857.

Original abbreviated new drug

applications (ANDA’s): Office of

Generic Drugs (HFD–600), Center for

Drug Evaluation and Research, Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855.

Requests for opinion of the

applicability of this notice to a specific

product: Division of Prescription Drug

Compliance and Surveillance (HFD–

330), Center for Drug Evaluation and

Research, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855.

FOR FURTHER INFORMATION CONTACT:

Mary E. Catchings, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION:

I. Background

In a notice published in the Federal

Register of July 27, 1972 (37 FR 15027),

FDA announced its evaluations of

reports received from the National

Academy of Sciences/National Research

Council Drug Efficacy Study Group on

certain parenteral multivitamin drug

products. The agency stated that the

products, as then formulated, lacked

substantial evidence of effectiveness for

their claimed indications. The

conclusion was not based on any

individual vitamin’s lack of

effectiveness; rather, certain essential

vitamins in the available formulations

were either not included or included in

too great or too small amounts.

In a followup notice published in the

Federal Register of December 14, 1972

(37 FR 26623), FDA granted parenteral

multivitamin products a temporary

exemption (paragraph XIV, category 11)

from the time limits imposed for the

implementation of the Drug Efficacy

Study. The temporary exemption was

based primarily on the recognized

critical medical importance of