48968 Federal Register / Vol. 62, No. 181 / Thursday, September 18, 1997 / Proposed Rules

(2) A circuit court overrules or limits

itself on an issue that was the basis of

an Acquiescence Ruling;

(3) A Federal law is enacted that

removes the basis for the holding in a

decision of a circuit court that was the

subject of an Acquiescence Ruling; or

(4) We subsequently clarify, modify or

revoke the regulation or ruling that was

the subject of a circuit court holding

that we determined conflicts with our

interpretation of the Social Security Act

or regulations, or we subsequently

publish a new regulation(s) addressing

an issue(s) not previously included in

our regulations when that issue(s) was

the subject of a circuit court holding

that conflicted with our interpretation of

the Social Security Act or regulations

and that holding was not compelled by

the statute or Constitution.

[FR Doc. 97–24803 Filed 9–17–97; 8:45 am]

BILLING CODE 4190–11–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 111

[Docket No. 95N–0304]

RIN 0901–AA59

Dietary Supplements Containing

Ephedrine Alkaloids; Reopening of

Comment Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule; reopening of

comment period.

SUMMARY: The Food and Drug

Administration (FDA) is reopening from

September 18, 1997, to December 2,

1997, the comment period on the

proposed rule on dietary supplements

containing ephedrine alkaloids that was

published in the Federal Register of

June 4, 1997 (62 FR 30678). This action

is being taken to provide a renewed

opportunity for public comment after

the agency has rectified a number of

inadvertent omissions from the

administrative record. FDA is also

providing an opportunity for comment

on adverse event reports (AER’s) that

FDA has received since January 1997

and on new analytical data that FDA is

adding to the administrative record.

Finally, FDA is reopening the comment

period in response to several requests

for extensions of the comment period to

permit interested persons to submit new

scientific data.

DATES: Written comments by December

2, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), 12420 Parklawn Dr., rm. 1–

23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Margaret C. Binzer, Center for Food

Safety and Applied Nutrition (HFS–

456), Food and Drug Administration,

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

202–401–9859, FAX 202–260–8957 or

E-mail ‘‘MBinzer @Bangate.fda.gov’’.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 4, 1997, FDA

published a proposed rule regarding the

formulation and labeling of dietary

supplements containing ephedrine

alkaloids. FDA proposed this rule in

response to serious illnesses and

injuries, including multiple deaths,

associated with the use of dietary

supplement products that contain

ephedrine alkaloids and in response to

the agency’s investigations and analyses

of these illnesses and injuries. Interested

persons were given until August 18,

1997, to comment on the proposal.

In the Federal Register of August 20,

1997 (62 FR 44247), FDA announced

that it would reopen the comment

period for the proposed rule because the

agency had identified a number of

inadvertent omissions (i.e., missing

pages in several of the AER’s and other

minor problems) in the administrative

record. FDA has reviewed each of the

AER’s to rectify these omissions, which

included: Missing product labels or

labeling, affidavits from consumers or

health care professionals, investigator

followup reports, and individual pages

from medical records. FDA has recopied

each of the AER files and placed them

on display at the Dockets Management

Branch. Any followup materials that the

agency received after the AER’s were

made part of the administrative record

for this rulemaking in June 1997 are

now included in the corresponding

AER. For convenience to the users of the

administrative record, the agency has

also organized the duplicate AER files to

make it easier to locate them in the

record.

As of January 1997, FDA had received

over 800 reports of adverse events

associated with the use of more than

100 different dietary supplements that

contained, or were suspected of

containing, ephedrine alkaloids. Since

that time, FDA has continued to receive

additional AER’s associated with the

use of these products. FDA is adding the

AER’s that it received between January

and August 1997 to supplement the

administrative record. These documents

are filed in the administrative record

under the title: ‘‘AER’s Associated with

the Use of Dietary Supplements

Containing Ephedrine Alkaloids that

FDA has Received Since the Preparation

of the Docket Submission of January 17,

1997.’’

Since the time that the proposal was

published, FDA has received the results

of chemical analyses for several of the

dietary supplement products associated

with AER’s. When an adverse event

appears to be clinically significant, FDA

routinely requests from the consumer a

sample of the remaining portion of the

product related to the AER and has its

laboratories analyze the sample. These

analytical results provide

supplementary data on levels of

ephedrine alkaloids in the dietary

supplements. FDA is adding these

analytical results to the administrative

record. A summary of these analytical

results are filed in the administrative

record under the title: ‘‘Analytical

Results of Ephedrine AlkaloidContaining Dietary Supplements

Associated With Adverse Events,

August 1997.’’ These documents will be

placed on display in the Dockets

Management Branch along with the rest

of the administrative record that FDA

has compiled to date.

In addition, FDA has received several

requests for extensions of the comment

period. These requests stated as grounds

for an extension, among other things,

that there is a need for additional time

to review the clinical data and other

information in the administrative record

and to submit new scientific data to the

agency. Several requests were for

extensions of 180 days.

Having carefully considered these

requests and given the fact that it has

added material to the administrative

record, the agency has decided to

reopen the comment period until

December 2, 1997. The reopening of the

comment period will provide interested

persons with a significant amount of

additional time to evaluate all the

information in the administrative record

that underlies the proposal that FDA

published in June 1997 and to formulate

any comments that they deem

appropriate. The agency particularly

encourages small businesses to take

advantage of this additional opportunity

to participate in the regulatory process.

Because of the serious and significant

adverse events associated with the use

of dietary supplements containing

ephedrine alkaloids, FDA is concerned

about the adverse impact that a

prolonged comment period may have on

the public health. For this reason, the

agency decided not to grant the requests

for an additional comment period longer

than 75 days. The agency’s decision to

reopen the comment period for 75 days

balances the needs of interested persons
Federal Register / Vol. 62, No. 181 / Thursday, September 18, 1997 / Proposed Rules 48969

to review the data in the corrected

administrative record and to submit

comments to the agency with the

important public health interests

involved.

Moreover, the agency does not intend

to provide any additional extensions of

the comment period. Interested persons

will have 75 days to consider these

materials and comment to the agency, if

desired. Interested persons already have

had 75 days to review the concepts in

the proposed rule and the data in the

administrative record, which represent

the great bulk of the material in the

updated and corrected administrative

record. Much of the material in the

administrative record has been on

display at the Dockets Management

Branch since long before the proposed

rule was published on June 4, 1997. A

notice appeared in the Federal Register

of September 21, 1995 (60 FR 49194),

announcing: The availability of AER’s

associated with the use of dietary

supplements containing ephedrine

alkaloids; redacted copies of

accompanying medical records, where

available; and a bibliography of

published medical and scientific

literature relevant to the AER’s. Much of

the clinical data and other information

has been in the administrative record

either since October 1995, the date of

the meeting of the Special Working

Group on Dietary Supplements

Containing Ephedrine Alkaloids

(Working Group) or since August 1996,

the date of the meeting of the Food

Advisory Committee and Special

Working Group. Other than the new

information announced in this

document, the agency has not added

new data to the administrative record

since January 1997. Nevertheless, for the

reasons mentioned earlier in this notice,

the agency is providing a new, full 75-

day comment period that is equal to the

comment period that FDA provided

when it published the initial proposal.

Thus, FDA is providing a total of 150

days for comment in this proceeding.

Interested persons may on or before

December 2, 1997, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. 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. Received

comments may be seen in the office

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

Monday through Friday.

Dated: September 12, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–24734 Filed 9–17–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF VETERANS

AFFAIRS

38 CFR Part 21

RIN 2900–AI58

Veterans Education: Reduction in

Required Reports

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

SUMMARY: This document proposes to

amend the educational assistance and

educational benefits regulations of the

Department of Veterans Affairs (VA). It

proposes to change the nature of the

information to be reported by veterans

and servicemembers receiving

educational assistance under the

Montgomery GI Bill—Active Duty

program and the number of reports

required of educational institutions in

which these veterans and

servicemembers are enrolled. It appears

that these changes would streamline the

operation of this program and reduce

the information collection burden for

this program, while maintaining the

program’s integrity. This document also

requests Paperwork Reduction Act

comments concerning the collections of

information contained in this document.

DATES: Comments must be received on

or before November 17, 1997.

ADDRESSES: Mail or hand deliver written

comments to: Director, Office of

Regulations Management (02D),

Department of Veterans Affairs, 810

Vermont Ave., NW, Room 1154,

Washington, DC 20420. Comments

should indicate that they are submitted

in response to ‘‘RIN 2900–AI58’’. All

written comments received will be

available for public inspection at the

above address in the Office of

Regulations Management, Room 1158,

between the hours of 8:00 a.m. and 4:30

p.m., Monday through Friday (except

holidays).

FOR FURTHER INFORMATION CONTACT: June

C. Schaeffer, Assistant Director for

Policy and Program Administration,

Education Service, Veterans Benefits

Administration, 202–273–7187.

SUPPLEMENTARY INFORMATION: This

document proposes to amend the ‘‘ALL

VOLUNTEER FORCE EDUCATIONAL

ASSISTANCE PROGRAM

(MONTGOMERY GI BILL—ACTIVE

DUTY)’’ regulations set forth at 38 CFR

Part 21, Subpart K. Except for

correspondence course enrollments, a

veteran or servicemember receiving

educational assistance under these

provisions is required to verify, after the

fact, pursuit of a program of education

each month (referred to below as

monthly verification). Current

regulations specify the information that

must be reported in the monthly

verification. Except in advance payment

and lump sum payment cases, VA does

not pay educational assistance until VA

receives this monthly verification.

Since pursuit of a program of

education is a necessary prerequisite to

receipt of educational assistance under

the educational programs VA

administers, current regulations also

require (see § 21.7156) a veteran or

servicemember to report, on a ‘‘without

delay’’ basis (referred to below as

‘‘without delay’’ reporting), each change

in her or his hours of credit being

pursued and any changes in the status

of his or her pursuit of the program.

This duty to provide ‘‘without delay’’

reporting is in addition to the monthly

verification described above. Further,

under § 21.7156 educational institutions

also are required ‘‘without delay’’ or

within specified time frames (all

reporting required of educational

institutions ‘‘without delay’’ or within

specified time frames is referred to

below as ‘‘without delay’’ reporting) to

report changes in the number of hours

of credit pursued and changes in

attendance.

The common purpose of these

information collections is to allow VA

to determine whether a veteran or

servicemember continues to be entitled

to educational assistance and, if so, to

release the monthly payment to the

veteran or servicemember.

However, it does not appear necessary

to obtain monthly verification from a

veteran who has received an advance

payment for the month in question.

Advance payments are not submitted by

VA directly to the veteran. Instead, they

are delivered to the educational

institution where the veteran is

pursuing a program of education. If the

veteran does not begin training, the

educational institution returns the

payment to VA instead of delivering it

to the veteran. Accordingly, it appears

that no useful purpose is served by

requiring a veteran to provide a monthly

verification concerning pursuit of a

program of education for a month for

which he or she has received an

advance payment. Therefore, it is

proposed to amend § 21.7154 to

eliminate the requirement that the

veteran provide monthly verification for

those monthly periods for which