Federal Register / Vol. 63, No. 125 /Tuesday, June 30, 1998 / Notices 35601

as late and will not be considered in the

competition.

2. Deadline. Mailed applications shall

be considered as meeting an announced

deadline if they are either received on

or before the deadline date or sent on or

before the deadline date and received by

ACF in time for the independent review

to: U.S. Department of Health and

Human Services, Administration for

Children and Families, Division of

Discretionary Grants, Attention: Lois

Hodge/Tribal Child Support, 370

L’Enfant Promenade, S.W., Mail Stop

6C–462, Washington, D.C. 20447.

Applicants must ensure that a legibly

dated U.S. Postal Service postmark or a

legibly dated, machine-produced

postmark of a commercial mail service

is affixed to the envelope/package

containing the application(s). To be

acceptable as proof of timely mailing, a

postmark from a commercial mail

service must include the logo/emblem

of the commercial mail service company

and must reflect the date the package

was received by the commercial mail

service company from the applicant.

Private Metered postmarks shall not be

acceptable as proof of timely mailing.

(Applicants are cautioned that express/

overnight mail services do not always

deliver as agreed.)

Applications handcarried by

applicants, applicant couriers, or by

other representatives of the applicant

will be considered as meeting an

announced deadline if they are received

on or before the deadline date, between

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

EST, at the U.S. Department of Health

and Human Services, Administration for

Children and Families, Division of

Discretionary Grants, ACF Mailroom,

2nd Floor (near loading dock),

Aerospace Building, 901 D Street, S.W.,

Washington, D.C. 20024, between

Monday and Friday (excluding Federal

holidays). The address must appear on

the envelope/package containing the

application with the note ‘‘Attention:

Lois Hodge/Tribal Child Support.’’ ACF

cannot accommodate transmission of

applications by fax or through other

electronic media. Therefore,

applications transmitted to ACF

electronically will not be accepted

regardless of date or time of submission

and time of receipt.

3. Late applications. Applications

which do not meet the criteria above are

considered late applications. ACF shall

notify each late applicant that its

application will not be considered in

the current competition.

4. Extension of deadlines. ACF may

extend an application deadline for

applicants affected by acts of God such

as floods and hurricanes, or when there

is widespread disruption of the mails. A

determination to waive or extend

deadline requirements rests with the

Chief Grants Management Officer.

Dated: June 19, 1998.

David Gray Ross,

Commissioner, Office of Child Support

Enforcement.

[FR Doc. 98–17265 Filed 6–29–98; 8:45 am]

BILLING CODE 4184–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0022]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Food and Drug

Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish a notice in the Federal Register

concerning each collection of

information, including each proposed

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

reporting and recordkeeping

requirements relating to the

manufacture and distribution of hearing

aid devices.

DATES: Submit written comments on the

collection of information requirements

by August 31, 1998.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. All comments should be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

including each proposed extension 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 collections of

information set forth below.

With respect to the following

collections of information, FDA invites

comments on: (1) Whether the proposed

collections of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of the agency’s

estimates of the burdens of the proposed

collections of information, including the

validity of the methodologies and

assumptions used; (3) ways to enhance

the quality, utility, and clarity of the

information to be collected; and (4)

ways to minimize the burdens of the

collections of information on

respondents, including through the use

of appropriate automated collection

techniques, when appropriate, and other

forms of information technology.

Hearing Aid Devices: Professional and

Patient Package Labeling and

Conditions for Sale—21 CFR 801.420

and 801.421 (OMB Control Number

0910–0171—Extension)

Under section 520(e) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360j(e)), the Secretary of the

Department of Health and Human

Services may, under certain conditions,

require by regulation that a device be

restricted to sale, distribution, or use

only upon authorization of a licensed

practitioner or upon other prescribed

conditions. Sections 801.420 and

801.421 (21 CFR 801.420 and 801.421)

implement this authority for hearing

aids, which are restricted devices. The

regulations require that the

manufacturer or distributor provide to

the user data useful in selecting, fitting,

and checking the performance of a

hearing aid through distribution of a

User Instructional Brochure. The User

Instructional Brochure must also

contain technical data about the device,

instructions for its use, maintenance,

and care, a warning statement, a notice

about the medical evaluation
35602 Federal Register / Vol. 63, No. 125 /Tuesday, June 30, 1998 / Notices

requirement, and a statement if the aid

is rebuilt or used.

Hearing aid dispensers are required to

provide the prospective user, before the

sale of a hearing aid, with a copy of the

User Instructional Brochure for the

hearing aid model that has been, or may

be, selected for the prospective user and

to review the contents of the brochure

with the buyer. In addition, upon

request by an individual who is

considering the purchase of a hearing

aid, the dispenser is required to provide

a copy of the User Instructional

Brochure for that model hearing aid or

the name and address or telephone

number of the manufacturer or

distributor from whom a User

Instructional Brochure for the hearing

aid may be obtained. Under conditions

of sale of hearing aid devices,

manufacturers or distributors shall

provide sufficient copies of the User

Instructional Brochure to sellers for

distribution to users and prospective

users and provide a copy of the User

Instructional Brochure to any health

care professional, user, or prospective

users who requests a copy in writing.

The regulations also require that the

patient provide a written statement that

he or she has undergone a medical

evaluation within the previous 6

months before the hearing aid is

dispensed, although informed adults

may waive the medical evaluation

requirement by signing a written

statement. Finally, the regulation

requires that the dispenser retain for 3

years copies of all physician statements

or any waivers of medical evaluations.

The information obtained through this

collection of information is used by

FDA to ensure that hearing aids are sold

and used in a way consistent with the

public health.

The information contained in the User

Instructional Brochure is intended not

only for the hearing aid user but also for

the physician, audiologist, and

dispenser. The data is used by these

health care professionals to evaluate the

suitability of a hearing aid, to permit

proper fitting of it, and to facilitate

repairs. The data also permits the

comparison of the performance

characteristics of various hearing aids.

Noncompliance could result in a

substantial risk to the hearing impaired

because the physician, audiologist, or

dispenser would not have sufficient

data to match the aid to the needs of the

user.

The respondents to this collection of

information are hearing aid

manufacturers, distributors, dispensers,

health professionals, or other for profit

organizations.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—Estimated Annual Reporting Burden1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual ResponsesHours per

Response Total Hours

801.420(c) 40 5 200 40 8,000

801.421(a)(1) 9,900 52 514,800 0.10 51,480

801,421(a)(2) 9,900 97 960,300 0.30 288,090

801.421(b) 9,900 162 1,600,000 0.30 480,000

801.421(c) 9,900 5 49,700 0.17 8,449

Totals 836,019

11There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2.—Estimated Annual Recordkeeping Burden1

21 CFR Section No. of

Recordkeepers

Annual

Frequency of

Recordkeeping

Total Annual Records Hours per

Recordkeeper Total Hours

801.421(d) 9,900 162 1,600,000 0.25 400,000

11There are no capital costs or operating and maintenance costs associated with this collection of information.

Section 801.420(c) estimate assumes

that 40 hearing aid manufacturers/

distributors each distribute 5 different

models of hearing aids. Thus, the 40

hearing aid manufacturers/distributors

will provide 5 different User

Instructional Brochures to sellers for

distribution to prospective users and

users. The completion of each User

Instructional Brochure is estimated to

require 40 staff hours.

Sections 801.421(a)(1) and

801.421(a)(2) estimates are based on

information obtained in the FDA review

mentioned previously which revealed

that medical evaluations were obtained

in 32 percent of the sales and signed

waivers were obtained in 60 percent of

the sales. For § 801.421(a)(1) estimate,

the figure was derived by multiplying

the current number of annual hearing

aid sales (1.6 million) by .32 and then

dividing by the number of hearing aid

dispensers (9,900). FDA estimates that it

will take hearing aid dispensers .10

hours to request and obtain the required

medical evaluation documentation. For

§ 801.421(a)(2) estimate, the figure was

derived by multiplying the current

number of hearing aid sales (1.6 million)

by .60 and then dividing by the number

of hearing dispensers (9,900). FDA

estimates that it will take hearing aid

dispensers .30 hours to articulate the

required disclosure and prepare and

make available a waiver form for adults

18 years of age or older to sign. For

§ 801.421(b) estimate, FDA assumes that

9,900 hearing aid dispensers will have

162 sales annually. For all such sales,

the dispenser must provide the

prospective user a copy of the User

Instructional Brochure and the

opportunity to read and review the

contents with him/her orally, or in the

predominant method used during the

sale. FDA estimates that this exchange

will involve .30 staff hours.

Section 801.421(c) estimate assumes

that 40 hearing aid manufacturers/

distributors, and 9,900 dispensers will

provide copies of the User Instructional

Brochure to any health care

professional, user, or prospective user

who request a copy in writing. It is

estimated that 5 written requests for

copies of the brochures will be received

by each hearing aid manufacturer/

distributor and dispenser annually. It is

estimated that each request for a

brochure will take .17 staff hours to

complete. This effort consists of the

hearing aid manufacturer/distributor or
Federal Register / Vol. 63, No. 125 /Tuesday, June 30, 1998 / Notices 35603

hearing aid dispenser locating the

appropriate User Instructional Brochure

for the specific model and mailing the

brochure to the requester.

Section 801.421(d) recordkeeping

estimate assumes that 9,900 hearing aid

dispensers will each retain 162 records.

Each record documents the dispensing

of a hearing aid to a hearing aid user.

Each recordkeeping entry is estimated to

require 0.25 staff hours.

Dated: June 19, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–17289 Filed 6–29–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–0430]

Nalco Chemical Co.; Filing of Food

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Nalco Chemical Co. has filed a

petition proposing that the food additive

regulations be amended to provide for

the safe use of sodium acrylate/styrene

sulfonate copolymer for use as an

antiscalant boiler treatment where steam

from treated boilers may contact food.

DATES: Written comments on the

petitioner’s environmental assessment

by July 30, 1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Parvin M. Yasaei, Center for Food Safety

and Applied Nutrition (HFS–215), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3189.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 8A4598) has been filed by

Nalco Chemical Co., One Nalco Center,

Naperville, IL 60563. The petition

proposes to amend the food additive

regulations in § 173.310 Boiler water

additives (21 CFR 173.310) to provide

for the safe use of sodium acrylate/

sulfonated styrene copolymer for use as

an antiscalant boiler treatment where

steam from treated boilers may contact

food.

The potential environmental impact

of this action is being reviewed. To

encourage public participation

consistent with regulations issued under

the National Environmental Policy Act

(40 CFR 1501.4(b)), the agency is

placing the environmental assessment

submitted with the petition that is the

subject of this notice on public display

at the Dockets Management Branch

(address above) for public review and

comment. Interested persons may, on or

before July 30, 1998, submit to the

Dockets Management Branch (address

above) written comments. 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.

FDA will also place on public display

any amendments to, or comments on,

the petitioner’s environmental

assessment without further

announcement in the Federal Register.

If, based on its review, the agency finds

that an environmental impact statement

is not required and this petition results

in a regulation, the notice of availability

of the agency’s finding of no significant

impact and the evidence supporting that

finding will be published with the

regulation in the Federal Register in

accordance with 21 CFR 25.51(b)(1).

Dated: June 8, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–17292 Filed 6–29–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–0433]

Servo Delden BV; Filing of Food

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Servo Delden BV has filed a

petition proposing that the food additive

regulations be amended to provide for

the safe use of polyethylene glycol

mono-isotridecyl ether sulfate, sodium

salt as a surfactant in adhesives

intended for use in contact with food.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 8B4600) has been filed by

Servo Delden BV, c/o Keller and

Heckman, 1001 G St. NW., suite 500

West, Washington, DC 20001. The

petition proposes to amend the food

additive regulations to provide for the

safe use of polyethylene glycol monoisotridecyl ether sulfate, sodium salt as

a surfactant in adhesives intended for

use in contact with food.

The agency has determined under 21

CFR 25.32(i) that this action is of the

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

Dated: June 4, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–17321 Filed 6–29–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Center for Veterinary Medicine;

Change of Internet Address

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

change in the Internet address for the

Center for Veterinary Medicine (CVM)

to ensure that users can continue to

have uninterrupted access to CVM’s

Internet site. The CVM Internet site is

one of the agency’s methods of

communicating with the public

regarding the ongoing mission of CVM,

which is the organization within the

agency that regulates the manufacture

and distribution of animal drugs, feeds,

and related products.

FOR FURTHER INFORMATION CONTACT:

Jerome J. McDonald, Center for

Veterinary Medicine (HFV–16), Food

and Drug Administration, 7500 Standish