Federal Register / Vol. 69, No. 239 / Tuesday, December 14, 2004 / Notices 74529

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0515]

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Device 

Labeling Regulations

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 notice in the Federal Register

concerning each proposed 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 

medical device labeling regulations.

DATES: Submit written or electronic 

comments on the collection of 

information by February 14, 2005.

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (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:

Peggy Robbins, Office of Management 

Programs (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 collection of 

information set forth in this document.

With respect to the following 

collection of information, FDA invites 

comments on these topics: (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.

Medical Device Labeling Regulations—

21 CFR Parts 800, 801, and 809 (OMB 

Control No. 0910–0485)—Extension

Section 502 of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

352), among other things, establishes 

requirements for the label or labeling of 

a medical device so that it is not 

misbranded and subject to regulatory 

action. Certain provisions of section 502 

of the act require that manufacturers, 

importers, and distributors of medical 

devices disclose information about 

themselves or their devices on the labels 

or labeling of the devices. Section 502(b) 

of the act requires that, if the device is 

in a package, the label must contain the 

name and place of business of the 

manufacturer, packer, or distributor and 

an accurate statement of the quantity of 

the contents. Section 502(f) of the act 

provides that the labeling of a device 

must contain adequate directions for 

use. FDA may grant an exemption from 

the adequate directions for use 

requirement, if FDA determines that 

adequate directions for use are not 

necessary for the protection of the 

public health.

FDA regulations in parts 800, 801, 

and 809 (21 CFR parts 800, 801, and 

809) require manufacturers, importers, 

and distributors of medical devices to 

disclose to health professionals and 

consumers specific information about 

themselves or their devices on the label 

or labeling of their devices. FDA issued 

these regulations under the authority of 

sections 201, 301, 502, and 701 of the 

act (21 U.S.C. 321, 331, 352, and 371). 

Most of the regulations in parts 800, 

801, and 809 derive from the 

requirements of section 502 of the act, 

which provides, in part, that a device 

shall be misbranded if, among other 

things, its label or labeling fails to bear 

certain required information concerning 

the device, is false or misleading in any 

particular way, or fails to contain 

adequate directions for use.

Section 800.12 requires that packages 

of contact lens cleaning solutions 

include a tamper-resistant feature to 

prevent malicious adulteration. Sections 

800.10(a)(3) and 800.12(c) require that 

the label of contact lens cleaning 

solutions contain a prominent statement 

alerting consumers to the tamperresistant feature.

Section 800.10(b)(2) requires that the 

labeling of liquid ophthalmic 

preparations packed in multiple-dose 

containers include information as to 

duration of use and necessary warnings 

to afford adequate protection from 

contamination during use.

Section 801.1 requires that the label of 

a device in package form contain the 

name and place of business of the 

manufacturer, packer, or distributor.

Section 801.5 requires that the 

labeling of devices include directions 

under which the layman can use a 

device safely and for the purposes for 

which it is intended. Section 801.4 

defines ‘‘intended use’’. Where 

necessary, the labeling should include: 

(1) Statements of all conditions, 

purposes, or uses for which the device 

is intended, unless the device is a 

prescription device subject to the 

requirements of § 801.109; (2) quantity 

of dose; (3) frequency of administration 

or application; (4) duration of 

administration or application; (5) time 

of administration, e.g. in relation to 

meals, onset of symptoms, etc.; (6) route 

of method or application; and (7) 

preparation for use.

Section 801.61 requires that the 

principal display panel of an over-thecounter (OTC) device in package form 

must include a statement of the identity 

of the device. The statement of the 

identity of the device must include the 

common name of the device followed by 

an accurate statement of the principal 

intended actions of the device.

Section 801.62 requires that the label 

of an OTC device in package form must 

include a declaration of the net quantity 

of contents. The label must express the 

net quantity in terms of weight, 

measure, numerical count, or a 

combination of numerical count and 

weight, measure, or size.

Section 801.109 establishes labeling 

requirements for prescription devices. A 

prescription device is defined as a 

device which, because of its potential 

for harmful effect, the method of its use, 

74530 Federal Register / Vol. 69, No. 239 / Tuesday, December 14, 2004 / Notices 

or the collateral measures necessary to 

its use, is not safe except under the 

supervision of a practitioner licensed by 

law to use the device and, therefore, for 

which adequate directions for use by a 

layperson cannot be developed.

The label of the device must include: 

(1) The statement ‘‘Caution: Federal law 

restricts this device to sale by or on the 

order of a ‘______’’’. The blank is to be 

filled in by a term such as ‘‘physician,’’

‘‘dentist,’’ or other appropriate term; 

and (2) the method of its application or 

use.

Labeling must include information for 

use, including indications, effects, 

routes, methods, frequency and duration 

of administration, and any relevant 

hazards, contraindications, side effects, 

and precautions under which 

practitioners licensed by law to 

administer the device can use the device 

safely and for the purpose for which it 

is intended, including all purposes for 

which it is advertised or represented. 

Information may be omitted from the 

dispensing package if, but only if, the 

article is a device for which directions, 

hazards, warnings, and other 

information are commonly known to 

practitioners licensed by law to use the 

device.

Section 801.110 establishes a labeling 

requirement for a prescription device 

delivered to the ultimate purchaser or 

user upon the prescription of a licensed 

practitioner. The device must be 

accompanied by labeling bearing the 

name and address of the licensed 

practitioner and the directions for use 

and cautionary statements, if any, 

contained in the order.

Section 801.405 establishes labeling 

requirements for articles intended for 

lay use in repairing and refitting 

dentures. The labeling must: (1) Limit 

directions for use for denture repair kits 

to emergency repair pending 

unavoidable delay in obtaining 

professional reconstruction of the 

denture; (2) limit directions for use for 

denture reliners, pads, and cushions to 

temporary refitting pending unavoidable 

delay in obtaining professional 

reconstruction of the denture; and (3) 

contain the word ‘‘emergency’’

preceding and modifying each 

indication-for-use statement for denture 

repair kits and the word ‘‘temporary’’

preceding and modifying each 

indication-for-use statement for reliners, 

pads, and cushions.

Section 801.410(f) requires that 

results of impact tests and description of 

the test method and apparatus be kept 

for a period of 3 years.

Section 801.410(f) is designed to 

protect the eyeglass wearer from 

potential eye injury resulting from 

shattering of ordinary eyeglass lenses 

and requires that eyeglasses and 

sunglasses be fitted with impactresistant lenses. Examination of data 

available on the frequency of eye 

injuries resulting from the shattering of 

ordinary crown glass lenses indicates 

that the use of such lenses constitutes 

an avoidable hazard to the eye of the 

wearer. According to the Vision Council 

of America, 60 percent of the 

population, or 161 million Americans, 

wear prescription eyewear; 81 percent 

have eyeglasses, 3 percent have contact 

lenses only and 16 percent have both 

eyeglasses and contact lenses.

Section 801.420(c) requires that the 

manufacturers or distributors of hearing 

aids develop a User Instructional 

Brochure, which accompanies the 

device and is provided to the 

prospective user by the dispenser of the 

hearing aid. The brochure must contain 

detailed information on the use and 

maintenance of the hearing aid.

Section 801.421(b) requires the 

hearing aid dispenser to provide the 

prospective user a copy of the User 

Instructional Brochure and an 

opportunity to review the comments 

with him/her orally or in the 

predominant method of communication 

used during the sale.

Section 801.421(c) requires the 

hearing aid dispenser to provide, upon 

request, to the prospective purchaser of 

any hearing aid (s)he dispenses, a copy 

of the User Instructional Brochure or the 

name and address of the manufacturer 

or distributor from whom the brochure 

may be obtained.

Section 801.421(d) requires the 

hearing aid dispenser to retain copies of 

all physician statements or any waivers 

of medical evaluation for 3 years from 

the time of dispensing.

Section 801.435 requires condom 

manufacturers to include an expiration 

date in the labeling of the condom. The 

manufacturer must support the 

expiration date by data from quality 

control tests demonstrating physical and 

mechanical integrity of three random 

lots of the same product which were 

stored under accelerated and real time 

conditions.

Section 809.10(a) provides that a label 

for an in vitro diagnostic product must 

contain the following information:

1. The proprietary and established 

name;

2. The intended use or uses of the 

product;

3. For a reagent, a declaration of the 

established name, if any, and the 

quantity, proportion, and concentration 

of each reactive ingredient;

4. A statement of warnings and 

precautions for users;

5. For a reagent, appropriate storage 

instructions;

6. For a reagent, a means by which the 

user may be assured that the product 

meets the appropriate standards of 

identity, strength, quality, and purity;

7. For a reagent, a declaration of the 

net quantity of contents;

8. Name and place of business of the 

manufacturer, packer, and distributor; 

and

9. A lot or control number.

Section 809.10(b) provides that the 

labeling (package insert) accompanying 

the device must contain the following:

1. Proprietary name and established 

name, if any;

2. The intended use or uses;

3. A summary and explanation of the 

test;

4. The chemical, physical, 

physiological, or biological principles of 

the procedure;

5. Information about the reagents;

6. Information about the instruments;

7. Information about the specimen 

collection and preparation for analysis;

8. Information about the procedure;

9. Information about the results;

10. Information about the limitations 

of the procedure;

11. Expected values;

12. Specific performance 

characteristics;

13. A bibliography of pertinent 

references; and

14. Date of issuance of the last 

revision of the labeling.

Section 809.10(d) provides that the 

labeling for general purpose laboratory 

reagents may be exempt from the 

labeling requirements in § 809.10(a) and 

(b), if the labeling contains the 

following:

1. The proprietary name and 

established name of the reagent;

2. The established name and the 

quantity, proportion, and concentration 

of the reagent ingredient;

3. A statement of the purity and 

quality of the reagent;

4. A statement of warnings and 

precautions for users;

5. Appropriate storage instructions;

6. A declaration of the net quantity of 

contents;

7. Name and place of business of the 

manufacturer, packer, or distributor; 

and

8. A lot or control number.

Section 809.10(e) requires 

manufacturers of analyte specific 

reagents to include the following in the 

labeling:

1. The proprietary name and 

established name, if any, of the reagent;

2. A declaration of established name, 

if any, and quantity, proportion or 

concentration of the reagent ingredient;

Federal Register / Vol. 69, No. 239 / Tuesday, December 14, 2004 / Notices 74531

3. A statement of the purity and 

quality of the reagent;

4. A statement of warnings or 

precautions for users;

5. Appropriate storage instructions;

6. A declaration of the net quantity of 

contents;

7. Name and place of business of the 

manufacturer, packer, or distributor;

8. A lot or control number; and

9. The statement, ‘‘For analyte 

specific reagent use only. Analytical and 

performance characteristics are not 

established.’’

Section 809.10(f) requires that the 

labeling for OTC test sample collection 

systems for drugs of abuse testing bear 

the following information in a language 

appropriate for the intended users:

1. Adequate instructions for specimen 

collection and handling;

2. An identification system to ensure 

that specimens are not mixed up or 

otherwise misidentified at the 

laboratory;

3. The intended use or uses of the 

product;

4. A statement that confirmatory 

testing will be conducted on all samples 

that initially test positive;

5. A statement of warnings or 

precautions for users;

6. Adequate instructions on how to 

obtain test results from a person who 

can explain their meaning, including 

the probability of false positive and false 

negative results, as well as how to 

contact a trained health professional if 

additional information on interpretation 

of test results or followup counseling is 

desired; and

7. Name and place of business of the 

manufacturer, packer, or distributor.

Section 809.30(d) requires that 

manufacturers of analyte specific 

reagents (ASRs) assure that advertising 

and promotional materials for ASRs:

1. Include the identity and purity of 

the ASR and the identity of the analyte; 

and

2. Do not include any statement 

regarding analytical or clinical 

performance.

These estimates are based on FDA’s 

registration and listing database for 

medical device establishments, agency 

communications with industry, and 

FDA’s knowledge of and experience 

with device labeling. We have not 

estimated a burden for those 

requirements where the information to 

be disclosed is information that has 

been supplied by FDA. Also, we have 

not estimated a burden for that 

information that is disclosed to third 

parties as a usual and customary part of 

a medical device manufacturer, 

distributor, or importer’s normal 

business activities. We do not include 

any burden for time that is spent 

designing labels to improve the format 

or presentation.

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

Responses

Hours per

Response Total Hours 

800.10(a)(3) and 800.12(c) 4 10 40 1 40

800.10(b)(2) 4 10 40 40 1,600

801.1 20,000 3.5 70,000 0.1 7,000

801.5 2,000 3.5 7,000 22.35 156,450

801.61 1,000 3.5 3,500 1 3,500

801.62 200 5 1,000 1 1,000

801.109 18,000 3.5 63,000 17.77 1,119,510

801.110 10,000 50 500,000 0.25 125,000

801.405(b) 40 1 40 4 160

801.420(c) 40 5 200 40 8,000

801.421(b) 10,000 160 1,600,000 0.30 480,000

801.421(c) 10,000 5 50,000 0.17 8,500

801.435 45 1 45 96 4,320

809.10(a) and (b) 1,700 6 10,200 80 816,000

809.10(d) 300 2 600 40 24,000

809.10(e) 300 25 7,500 1 7,500

809.10(f) 20 1 20 100 2,000

809.30(d) 300 25 7,500 1 7,500

Total Burden Hours 2,772,080

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

74532 Federal Register / Vol. 69, No. 239 / Tuesday, December 14, 2004 / Notices 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section 

No. of

Recordkeepers

Annual Frequency

per Recordkeeping

Total Annual

Records

Hours per

Record Total Hours 

801.410(f) 30 769,000 23,070,000 641 19,225

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

Total Hours 419,225

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

Dated: December 6, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–27333 Filed 12–13–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND 

SECURITY 

Bureau of Customs and Border 

Protection 

Agency Information Collection 

Activities: User Fees

AGENCY: Bureau of Customs and Border 

Protection, Department of Homeland 

Security.

ACTION: Proposed collection; comments 

requested. 

SUMMARY: The Bureau of Customs and 

Border Protection (CBP) of the 

Department of Homeland Security has 

submitted the following information 

collection request to the Office of 

Management and Budget (OMB) for 

review and approval in accordance with 

the Paperwork Reduction Act of 1995: 

User Fees. This is a proposed extension 

of an information collection that was 

previously approved. CBP is proposing 

that this information collection be 

extended with a change to the burden 

hours. This document is published to 

obtain comments form the public and 

affected agencies. This proposed 

information collection was previously 

published in the Federal Register (69 

FR 56448) on September 21, 2004, 

allowing for a 60-day comment period. 

This notice allows for an additional 30 

days for public comments. This process 

is conducted in accordance with 5 CFR 

1320.10.

DATES: Written comments should be 

received on or before January 13, 2005.

ADDRESSES: Written comments and/or 

suggestions regarding the items 

contained in this notice, especially the 

estimated public burden and associated 

response time should be directed to the 

Office of Management and Budget, 

Office of Information and Regulatory 

Affairs, Attention: Department of 

Treasury Desk Officer, Washington, DC 

20503. Additionally comments may be 

submitted to OMB via facsimile to (202) 

395–6974.

SUPPLEMENTARY INFORMATION: The 

Bureau of Customs and Border 

Protection (CBP) encourages the general 

public and affected Federal agencies to 

submit written comments and 

suggestions on proposed and/or 

continuing information collection 

requests pursuant to the Paperwork 

Reduction Act of 1995 (Pub. L. 104–13). 

Your comments should address one of 

the following four points: 

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency/component, 

including whether the information will 

have practical utility; 

(2) Evaluate the accuracy of the 

agencies/components estimate of the 

burden of The proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and

(4) Minimize the burden of the 

collections 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, e.g., permitting 

electronic submission of responses. 

Title:User Fees. 

OMB Number: 1651–0052. 

Form Number: Form CBP–339. 

Abstract: The information collected 

on the User Fee Form CBP–339 is 

necessary in order for CBP to account 

for, and track user fees from private and 

commercial vessels, private aircraft, 

operators of commercial trucks, and 

passenger and freight railroad cars 

entering the United States and 

recipients of certain dutiable mail 

entries for certain official services. 

Current Actions: This submission is 

being submitted to extend the expiration 

date with a change in the burden hours. 

Type of Review: Extension (with 

change). 

Affected Public: Businesses or other 

for-profit. 

Estimated Number of Respondents:

45,000. 

Estimated Time Per Respondent: 5–10 

minutes. 

Estimated Total Annual Burden 

Hours: 4,166. 

Estimated Total Annualized Cost on 

the Public: $62,490. 

If additional information is required 

contact: Tracey Denning, Bureau of 

Customs and Border Protection, 1300 

Pennsylvania Avenue NW., Room 3.2.C, 

Washington, DC 20229, at 202–344–

1429.

Dated: December 7, 2004. 

Tracey Denning, 

Agency Clearance Officer, Information 

Services Branch.

[FR Doc. 04–27326 Filed 12–13–04; 8:45 am] 

BILLING CODE 4820–02–P

DEPARTMENT OF THE INTERIOR

Bureau of Land Management 

[ES–020–04–1320–EL] 

Notice of the Solicitation of Public 

Comments on Fair Market Value and 

Maximum Economic Recovery; Coal 

Lease by Application KYES–51002

AGENCY: Bureau of Land Management, 

Interior.

ACTION: Notice.

SUMMARY: The United States Department 

of Agriculture Forest Service, Daniel 

Boone National Forest, has prepared an 

Environmental Impact Statement (EIS) 

to address coal lease application KYES–

51002. The EIS has been prepared in 

cooperation with the Bureau of Land 

Management’s (BLM) Eastern States, 

Jackson Field Office, the Office of 

Surface Mining and the Kentucky 

Department of Surface Mining 

Reclamation and Enforcement. A public 

hearing, requesting input to the EIS, was 

held on November 24, 2003, at the 

Leslie County Extension Services office 

in Hyden, Kentucky. 

Public comments are requested on the 

fair market value (FMV) and maximum