Federal Register / Vol. 62, No. 218 / Wednesday, November 12, 1997 / Notices 60721

of an existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information listed below.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

User Fee Cover Sheet; Form FDA

3397—(OMB Control Number 0910–

0297)—Reinstatement

Under sections 735 and 736 of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 379g and 379h), FDA has the

authority to assess and collect user fees

for certain drug and biologic product

applications and supplements. Under

this authority, pharmaceutical

companies pay a fee for each new drug

application, biologic product license

application, biologic license

application, or supplement submitted

for review. Because the submission of

user fees concurrently with applications

and supplements is required, review of

an application cannot begin until the fee

is submitted. Form FDA 3397 is the user

fee cover sheet, which is designed to

provide the minimum necessary

information to determine whether a fee

is required for review of an application,

to determine the amount of the fee

required, and to account for and track

user fees. The form provides a crossreference of the fee submitted for an

application with the actual application

by utilizing a unique number tracking

system. The information collected is

used by FDA, Center for Drug

Evaluation and Research (CDER), and

Center for Biologics Evaluation and

Research (CBER) to initiate the

administrative screening of new drug

applications, new biologic product

license applications, and supplemental

applications.

Respondents to this collection of

information are drug and biologic

product applicants.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

Form No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

FDA 3397 200 9.44 1,888 .15 283

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

Based on the agency’s experience of 4

years, FDA estimates there are

approximately 200 manufacturers of

products subject to Prescription Drug

User Fee Act. Of the 200 manufacturers,

CDER estimates 141 are drug

manufacturers and CBER estimates 59

are biologics manufacturers. CDER

estimates 1,721 annual responses that

include the following: 125 new drug

applications, 1,098 chemistry

supplements, 400 labeling supplements,

and 98 efficacy supplements. CBER

estimates 167 annual responses that

include the following: 157 annual

product supplements, and 10 original

license applications.

Dated: November 3, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–29710 Filed 11-10-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0436]

Bottled Water Study: Feasibility of

Appropriate Methods of Informing

Customers of the Contents of Bottled

Water; Request for Comments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

public comment on what are feasible

methods for providing people who

purchase bottled water with information

about the contents of that bottled water

and on what information should be

provided. FDA will consider the

information that it receives in response

to this notice in conducting a study of

the feasibility of appropriate methods, if

any, for informing customers about the

contents of bottled water. FDA is

required to conduct the feasibility study

under the Safe Drinking Water Act

Amendments of 1996 (SDWA

Amendments).

DATES: Written comments by December

12, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Henry Kim, Center for Food Safety and

Applied Nutrition (HFS–306), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–260–0631.

SUPPLEMENTARY INFORMATION:

I. Background

On August 6, 1996, Congress passed,

and the President signed into law, the

SDWA Amendments (Pub. L. 104–182).

Under the SDWA Amendments’ Public

Notification (section 114) provisions

designed to further public awareness

about the quality of their drinking

water, section 114(a) mandates that, not

later than 24 months after the date of

enactment of this law, the

Environmental Protection Agency (EPA)

issue regulations requiring community

water systems to provide their

customers with an annual report,

referred to as a consumer confidence

report (CCR), that contains information

on the level of contaminants in drinking

water purveyed by the systems.

Parallel to this requirement, section

114(b) of the SDWA Amendments

requires that not later than 18 months

after the date of its enactment, FDA in
60722 Federal Register / Vol. 62, No. 218 / Wednesday, November 12, 1997 / Notices

consultation with EPA publish for

notice and comment a draft study on the

feasibility of appropriate methods, if

any, of informing customers of the

contents of bottled water. A final study

is to be published not later than 30

months after the date of enactment of

the SDWA Amendments.

II. Procedure for the Feasibility Study

In carrying out the provisions of

section 114(b) of the SDWA

Amendments, FDA intends to: (1)

Solicit through this notice information

on appropriate methods, if any, that are

feasible for conveying information about

the contents of bottled water to

customers; (2) evaluate the information

received to tentatively identify the

appropriate methods, if any, that are

feasible for conveying information about

the contents of bottled water to people

who purchase that bottled water; (3)

publish for notice and comment a draft

feasibility study report in which the

agency will present its tentative

findings; and (4) consider the comments

the agency receives on the draft

feasibility study report and publish a

final report on the feasibility of

appropriate methods, if any, for

providing information about the

contents of bottled water to customers.

In this notice, FDA is soliciting

information that it will use in

conducting the feasibility study. FDA is

requesting comments about: (1) The

methods, if any, that may be

appropriate, and why they are

appropriate, for conveying information

about the contents of bottled water to

consumers; (2) whether any appropriate

method is feasible as a means of

providing information about the

contents of bottled water to customers,

and the supporting reasons for why the

method is feasible; and (3) the type of

information about the contents of

bottled water that should be provided

within the context of the SDWA

Amendments.

FDA considers this solicitation of

information through this Federal

Register notice to be the most effective

means of obtaining information from all

segments of the general public (i.e.,

industries, trade associations,

consumers, consumer advocacy groups,

educational institutions) that are

interested in the subject of feasibility of

appropriate methods of providing

information about the contents of

bottled water to customers. FDA thus

deems this approach to be the most

appropriate means of obtaining

sufficient and pertinent information

from stakeholders for conducting the

feasibility study as required by the

SDWA Amendments.

III. Request for Information

A. Methods for Conveying Information

to Customers

FDA requests comments on what

methods, if any, are appropriate for

conveying to customers information

about the contents of bottled water. FDA

also requests for any method identified

that the comment state why that method

is appropriate for communicating

information about the contents of

bottled water to people who purchase

that product.

For example, for bottled waters that

are sold at retail (e.g., grocery stores),

comments may wish to address whether

it would be appropriate to provide the

information directly on the product’s

label or through an address or a toll-free

telephone number on the product’s label

that customers can write to or call to

obtain the information. In the latter

instance, would it be appropriate for

bottlers to operate a menu driven system

for callers to directly access the

information? Would it be appropriate

for bottlers to take the name and address

of the caller and mail the information in

the form of a pamphlet, for example?

Comments should provide the reasons

why any method identified is

appropriate.

Noting that the SDWA Amendments

require community water systems to

mail their annual CCR to customers,

comments may wish to address whether

it is appropriate for firms that deliver

bottled water to customer’s homes,

office buildings, schools, and hospitals

to mail the information to the customer

along with the invoice that they

normally provide. Why would

providing the information in this

manner be considered appropriate?

Recognizing the increasing

prominence of the Internet as a source

of public information, comments may

wish to address whether it is

appropriate for firms to provide

information about bottled water to

customers over the Internet. Again, why

would this method be deemed

appropriate?

FDA also requests comments about

other methods that are appropriate for

conveying information to customers

about the contents of bottled water, and

why they are appropriate.

B. Feasibility of Appropriate Methods

For each method identified as being

appropriate for conveying information

to customers about the contents of

bottled water, FDA also requests

information on whether the provision of

information by such method is feasible,

i.e., ‘‘capable of being done or carried

out’’ (Webster’s Third New International

Dictionary, 1976). Thus persons who

believe that an appropriate method is

feasible for a stated purpose should state

why the provision of information by

that method can be done or carried out,

i.e., is feasible. Likewise, interested

persons who believe that an appropriate

method is not feasible should state why

the provision of information by that

method cannot be done or carried out.

Comments should address the costs to

bottlers and all other relevant factors

that support the position they take with

respect to the feasibility of the method

in question.

For example, those who comment on

the possibility of providing information

directly on a product’s label should

address the feasibility of doing so in

light of the obvious concern about the

limited label space available on a

bottled water product. Is it feasible to

provide the subject information directly

on the label of a bottled water product

notwithstanding the limited label space,

or is the limited label space such a

significant obstacle that use of a

product’s label would not be feasible?

Again, by way of example, comments

that address providing the information

on the Internet should address

feasibility with respect to the cost of

establishing and maintaining an Internet

site, particularly for small firms.

C. Information on the Contents of

Bottled Water

FDA requests comments on the type

of information about the contents of

bottled water that should be provided to

convey to customers, to the extent

possible, information analogous to that

provided in a CCR. In this regard, FDA

notes that a CCR must contain: (1)

Information about the source of the

drinking water purveyed by the system;

(2) definitions for the terms ‘‘maximum

contaminant level goal’’ (MCLG),

‘‘maximum contaminant level’’ (MCL),

‘‘variances,’’ and ‘‘exemptions;’’ (3) the

MCLG, MCL, and the actual level found

for contaminants detected in the water

and, for any contaminants detected that

violated the MCL during the year,

information on the health effects that

led EPA to regulate that contaminant;

(4) information on compliance with

EPA’s National Primary Drinking Water

Regulations, and notice if the system is

operating under a variance or an

exemption and the basis on which the

variance or exemption was granted; (5)

information on the levels of unregulated

contaminants for which monitoring by

the system is required (including levels

of cryptosporidium and radon where

States determine that they may be

found); and (6) a statement that the

presence of contaminants in drinking
Federal Register / Vol. 62, No. 218 / Wednesday, November 12, 1997 / Notices 60723

water does not necessarily indicate that

the drinking water poses a health risk,

and that more information about

contaminants and potential health

effects can be obtained by calling the

EPA hotline.

What type of information about the

contents of bottled water could be

provided that would be analogous to the

previously described information

required in a CCR? For example,

because FDA establishes ‘‘allowable

levels’’ and not MCL’s for contaminants

in bottled water, would providing

information describing the term

‘‘allowable level’’ as established in

FDA’s quality standard regulation for

bottled water be analogous to the

provision of information about MCL’s

required in a CCR? Also, by way of an

example, for information concerning

MCLG’s, variances, exemptions that are

required in a CCR, are there similar or

analogous types of information with

respect to bottled water that could be

provided to customers?

IV. Comments

Interested persons may, on or before

December 12, 1997, submit to the

Dockets Management Branch (address

above) written comments regarding this

document. 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: November 3, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–29655 Filed 11-10-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Submission for OMB Review;

Comment Request; NLM Online

Application Packet

SUMMARY: In compliance with the

requirement of Section 3506(c)(2)(A) of

the Paperwork Reduction Act of 1995,

the National Library of Medicine (NLM),

the National Institutes of Health (NIH)

has submitted to the Office of

Management and Budget (OMB) a

request to review and approve the

information collection listed below.

This proposed information collection

was previously published in the Federal

Register on July 10, 1997, page number

37068, and allowed 60 days for public

comment. No public comments were

received. The purpose of this notice is

to allow an additional 30 days for public

comment. The National Institutes of

Health may not conduct or sponsor, and

the respondent is not required to

respond to, an information collection

that has been extended, revised, or

implemented on or after October 1,

1995, unless it displays a currently valid

OMB control number.

PROPOSED COLLECTION: Title: NLM

Online Application Packet. Type of

Information Collection Request:

Extension of OMB No. 0925–0223.

Expires 11/30/97. Need and Use of

Information Collection: The NLM uses

the information provided by individuals

and institutions for MEDLARS online

system user code assignments and

invoices for system use. Frequency of

Response: On occasion. Affected Public:

Individuals or households; businesses

or other for profit; State or local

governments; Federal agencies; Nonprofit institutions; Small businesses or

organizations. Type of Respondents:

Organizations, Health Care Providers,

Students. The annual reporting burden

is as follows: Estimated Number of

Respondents annually: 2,640. Estimated

Number of Responses per Respondent:

1; Average Burden Hours Per Response:

0.0833 hours; and Estimated Total

Annual Burden Hours Requested: 219.

The annualized cost to respondents is

estimated at: $11,383. There are no

capital costs to report. There are no

operating or maintenance costs to

report.

REQUEST FOR COMMENTS: Written

comments and/or suggestions from the

public and affected agencies are invited

on one or more of the following points:

(1) Whether the proposed collection of

information is necessary for the proper

performance of the function of the

agency, including whether the

information will have practical utility;

(2) The accuracy of the agency’s

estimate of the burden of the proposed

collection of information; (3) Ways to

enhance the quality, utility, and clarity

of the information to be collected; and

(4) Ways to minimize the burden of the

collection of information on those who

are to respond, including the use of

appropriate automated, electronic,

mechanical, or other technological

collection techniques or other forms of

information technology.

DIRECT COMMENTS TO OMB: Written

comments and/or suggestions regarding

the items(s) contained in this notice,

especially regarding the estimated

public burden and associated response

time, should be directed to the: Office

of Management and Budget, Office of

Regulatory Affairs, New Executive

Office Building, Room 10235,

Washington, D.C. 20503, Attention:

Desk Officer for NIH. To request more

information on the proposed project or

to obtain a copy of the data collection

plans and instruments, contact: Carolyn

Tilley, Head, Medlars Management

Section, BSD, LO, NLM, NIH, Building

38A, Room 4N–04, 8600 Rockville Pike,

Bethesda, MD 20894, or call non-toll

free number (301) 402–1076 or E-mail

your request, including your address to:

carolynltilley@ccmail.nlm.nih.gov.

COMMENTS DUE DATE: Comments

regarding this information collection are

best assured of having their full effect if

received on or before December 12,

1997.

Dated: November 3, 1997.

Donald C. Poppke,

Executive Officer, NLM.

[FR Doc. 97–29669 Filed 11–10–97; 8:45 am]

BILLING CODE 4410–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Notice of

Meeting

Pursuant to Section 10(a) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of a meeting of the

President’s Cancer Panel.

This meeting will be open to the

public as indicated below, with

attendance by the public limited to

space available. Individuals who plan to

attend and need special assistance, such

as sign language interpretatin or other

reasonable accommodations, should

notify Linda Quick-Cameron,

Committee Management Officer,

National Cancer Institute, Executive

Plaza North, Room 609, 6130 Executive

Blvd., MSC 7410, Bethesda, MD 20892–

7410 (301/496–5708). A summary of the

meeting and the roster of committee

members will be provided upon request.

Other information pertaining to the

meeting may be obtained from the

contact person indicated below.

Committee Name: President’s Cancer

Panel.

Date: November 21, 1997.

Place: Moffitt Cancer Center, Research

Center (Across from Cancer Center), 12902

Magnolia Drive, Tampa, FL 33612.

Open: 8:00 a.m. to Adjournment.

Agenda: Concerns of special populations

in the National Cancer Program: