Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 /Rules and Regulations 40647

to participate in this rulemaking

proceeding by submitting written

comments on the proposal to the FAA.

No comments were received. Except for

editorial changes this amendment is the

same as that proposed in the notice.

The Rule

This action amends part 71 by

lowering the floor of a portion of V–465

from 12,400 MSL to 1,200 feet above the

surface. This action supports the

instrument approach procedure

requirements into the Jackson Hole

Airport, Jackson, WY.

This action also establishes a new

segment of V–465 between Billings, MT,

and Miles City, MT. When V–465 was

established, the FAA intended that the

airway include a segment between

Billings, MT, and Miles City, MT;

however, the airway segment was

omitted due to a typographical error.

This action properly defines that

portion of V–465 between Billings, MT,

and Miles City, MT, that was omitted in

previous publications. This new

segment does not result in any

additional controlled airspace because

the segment is co-located with a

segment of V–2.

The FAA is taking this action to

enhance the management of air traffic

operations in the Jackson Hole, WY,

area.

The FAA has determined that this

regulation only involves an established

body of technical regulations for which

frequent and routine amendments are

necessary to keep them operationally

current. Therefore, this regulation: (1) is

not a ‘‘significant regulatory action’’

under Executive Order 12866; (2) is not

a ‘‘significant rule’’ under DOT

Regulatory Policies and Procedures (44

FR 11034; February 26, 1979); and (3)

does not warrant preparation of a

regulatory evaluation as the anticipated

impact is so minimal. Since this is a

routine matter that will only affect air

traffic procedures and air navigation, it

is certified that this rule, when

promulgated, will not have a significant

economic impact on a substantial

number of small entities under the

criteria of the Regulatory Flexibility Act.

Domestic VOR Federal airways are

published in paragraph 6010(a) of FAA

Order 7400.9E, dated September 10,

1997, and effective September 16, 1997,

which is incorporated by reference in 14

CFR 71.1. The airways listed in this

document will be published

subsequently in the Order.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference,

Navigation (air).

Adoption of the Amendment

In consideration of the foregoing, the

Federal Aviation Administration

amends 14 CFR part 71 as follows:

PART 71—DESIGNATION OF CLASS A,

CLASS B, CLASS C, CLASS D, AND

CLASS E AIRSPACE AREAS;

AIRWAYS; ROUTES; AND REPORTING

POINTS

1. The authority citation for part 71

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389.

§ 71.1 [Revised]

2. The incorporation by reference in

14 CFR 71.1 of the Federal Aviation

Administration Order 7400.9E, Airspace

Designations and Reporting Points,

dated September 10, 1997, and effective

September 16, 1997, is amended as

follows:

Paragraph 6010(a)—Domestic VOR Federal

Airways

* * * * *

V–465 [Revised]

From Bullion, NV, Wells, NV; 12 miles; 30

miles, 115 MSL, 20 miles, 90 MSL, 36 miles,

115 MSL, 24 miles, 95 MSL, Malad City, ID;

Jackson, WY; Dunoir, WY; 14 miles, 45 miles,

137 MSL, Billings, MT; Miles City, MT;

Williston, ND.

* * * * *

Issued in Washington, DC, on July 24,

1998.

Reginald C. Matthews,

Acting Program Director for Air Traffic

Airspace Management.

[FR Doc. 98–20341 Filed 7–29–98; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 310 and 341

[Docket No. 76N–052N]

RIN 0910–AA01

Cold, Cough, Allergy, Bronchodilator,

and Antiasthmatic Drug Products for

Over-the-Counter Human Use;

Amendment of Monograph for OTC

Nasal Decongestant Drug Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

final monograph for over-the-counter

(OTC) nasal decongestant drug products

(drug products used to relieve nasal

congestion caused by acute or chronic

rhinitis) to add the ingredient

levmetamfetamine (formerly ldesoxyephedrine) and to classify this

ingredient as generally recognized as

safe and effective for OTC use. The

agency is also removing ldesoxyephedrine from the list of

nonmonograph active ingredients. This

final rule is part of the ongoing review

of OTC drug products conducted by

FDA.

EFFECTIVE DATE: July 30, 1999.

FOR FURTHER INFORMATION CONTACT:

Cazemiro R. Martin, Center for Drug

Evaluation and Research (HFD–560),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2222.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of August 23,

1994 (59 FR 43386), the agency

published a final rule in the form of a

final monograph establishing conditions

under which OTC nasal decongestant

drug products are generally recognized

as safe and effective. The final

monograph did not include ldesoxyephedrine as a nasal

decongestant active ingredient because

it was not currently standardized and

characterized for quality and purity in

an official compendium, i.e., the United

States Pharmacopeia (USP)/National

Formulary (59 FR 43386 at 43408).

Instead, the final rule listed ldesoxyephedrine in

§ 310.545(a)(6)(ii)(B) (21 CFR

310.545(a)(6)(ii)(B)) as not generally

recognized as safe and effective. The

agency stated in the final rule that OTC

drug products containing ldesoxyephedrine as a topical nasal

decongestant active ingredient were

new drugs under section 201(p) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 321(p)). The effective date of

the final rule was August 23, 1995.

In the Federal Register of March 8,

1996 (61 FR 9570), the agency stayed

the entry for ‘‘l-desoxyephedrine

(topical)’’ in § 310.545(a)(6)(ii)(B) until

further notice. The agency explained

that a citizen petition submitted in

response to the OTC nasal decongestant

final rule requested that the agency

defer the effective date of

§ 310.545(a)(6)(ii)(B) as it applies to ldesoxyephedrine (topical) until

December 31, 1996. The petitioner

stated that it had forwarded a draft

compendial monograph for ldesoxyephedrine to the USP in late July

1995. The agency added that when ldesoxyephedrine becomes official in the
40648 Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 /Rules and Regulations

USP, the final monograph for OTC nasal

decongestant drug products would be

amended to include the active

ingredient and § 310.545(a)(6)(ii)(B)

would be revised accordingly. The

agency provided certain labeling

requirements that would be in effect for

topical nasal decongestant drug

products containing l-desoxyephedrine

during the stay (61 FR 9570).

II. Recent Developments

In the Pharmacopeial Forum of

January/February 1997 (Ref. 1), USP

proposed a monograph for ldesoxyephedrine. Based on the United

States Adopted Names (USAN)

Council’s recommendation, the proposal

included levmetamfetamine as the new

name for l-desoxyephedrine. The USAN

Council and USP used the International

Nomenclature Name (INN),

levmetamfetamine, in place of ldesoxyephedrine. Levmetamfetamine is

the title of the monograph adopted in

the 6th Supplement of USP 23 (Ref. 2).

In response to the USP proposed

monograph for levmetamfetamine (Ref.

1), the agency at that time expressed its

strong objection and the objection of the

U.S. Department of Justice, Drug

Enforcement Administration (DEA)

concerning the USAN Council’s

recommendation to adopt

‘‘levmetamfetamine’’ as the

nonproprietary name for ldesoxyephedrine (Ref. 3). The agency

indicated to the Council that both FDA

and DEA shared concerns about an

increased use of methamphetamine in

the United States and with the largescale diversion of some OTC drug

products for illicit use in the

manufacture of the controlled

substances methamphetamine and

methcathinone. Both agencies had

concerns that the new name,

levmetamfetamine, might draw the

attention of potential drug abusers to

these OTC nasal decongestant drug

products if they contain

‘‘metamfetamine’’ in their name. The

agency pointed out that although ldesoxyephedrine is a nonnarcotic

substance (21 CFR 1308.22), an OTC

drug product label containing a soundalike name, such as

‘‘levmetamfetamine’’ may encourage

intentional misuse. For these concerns,

the agency asked the USAN Council to

reconsider the proposed name change.

At its January 27, 1997, meeting, the

USAN Council considered the agency’s

request regarding the name change of ldesoxyephedrine to

‘‘levmetamfetamine’’ and voted to retain

the name for the following reasons (Ref.

4): (1) Levmetamfetamine is

nonaddictive, (2) the new name is

consistent with INN policy, and (3) any

other name for l-desoxyephedrine may

also be confusing. At this time, the

agency accepts the USAN Council’s

decision and is using levmetamfetamine

as the new name for l-desoxyephedrine

in the OTC nasal decongestant final

monograph.

III. The Agency’s Final Conclusions

Based on the new USP monograph for

levmetamfetamine, the agency is

amending the final monograph for OTC

nasal decongestant drug products to

include levmetamfetamine in

§ 341.20(b)(1) (21 CFR 341.20(b)(1)) as a

safe and effective OTC nasal

decongestant active ingredient. The

agency is also adding labeling for

products containing this ingredient to

the OTC nasal decongestant final

monograph as follows:

1. In § 341.80(c)(2)(ii) (21 CFR

341.80(c)(2)(ii): For products containing

levmetamfetamine identified in

§ 341.20(b)(1) when used in an inhalant

dosage form and when labeled for

adults. ‘‘Do not use this product for

more than 7 days. Use only as directed.

Frequent or prolonged use may cause

nasal congestion to recur or worsen. If

symptoms persist, ask a doctor.’’

2. In § 341.80(c)(2)(vii): For products

containing levmetamfetamine identified

in § 341.20(b)(1) when used in an

inhalant dosage form and when labeled

for children under 12 years of age. ‘‘Do

not use this product for more than 7

days. Use only as directed. Frequent or

prolonged use may cause nasal

congestion to recur or worsen. If

symptoms persist, ask a doctor.’’

3. In § 341.80(d)(2)(i): For products

containing levmetamfetamine identified

in § 341.20(b)(1) when used in an

inhalant dosage form. ‘‘The product

delivers in each 800 milliliters of air

0.04 to 0.150 milligrams of

levmetamfetamine. Adults: 2

inhalations in each nostril not more

often than every 2 hours. Children 6 to

under 12 years of age (with adult

supervision): 1 inhalation in each

nostril not more often than every 2

hours. Children under 6 years of age:

ask a doctor.’’

4. In § 341.80(d)(2)(viii), the agency is

expanding the header to read: ‘‘Other

required statements—For products

containing levmetamfetamine or

propylhexedrine identified in

§ 341.20(b)(1) or (b)(9) when used in an

inhalant dosage form.’’

The agency is also amending

§ 310.545(a)(6)(ii)(B) by removing the

entry for ‘‘l-desoxyephedrine (topical).’’

IV. Labeling Guidance

In the Federal Register of February

27, 1997 (62 FR 9024), FDA proposed to

establish a standardized format for the

labeling of OTC drug products. The

labeling in this final rule does not

follow the new format because the

proposal has not been finalized to date.

However, the agency is providing

manufacturers guidance on how

labeling in this final rule would be

converted into the format proposed in

§ 201.66 (62 FR 9024 at 9050 and 9051).

The purpose and use of the products are

already listed in and would follow

§ 341.80(a) and (b) of the final

monograph for OTC nasal decongestant

drug products. The directions would

appear as stated in this final rule and in

§ 341.80(d)(2)(viii). The warnings in

§ 341.80(c)(2)(ii) and (c)(2)(vii) would

meet the requirements of proposed

§ 201.66(c)(4) as follows:

TABLE 1.—CONVERSION OF MONOGRAPH WARNINGS TO PROPOSED NEW FORMAT

Nasal Decongestant Final Monograph February 27, 1997, Proposal

Do not use this product for more than 7 days. DO NOT USE:

for more than 7 days

If symptoms persist, ask a doctor. STOP USING THIS PRODUCT IF:

symptoms persist

ASK A DOCTOR. THESE MAY BE SIGNS OF A SERIOUS CONDITION.

Use only as directed. WHEN USING THIS PRODUCT:

use only as directed

frequent or prolonged use may cause nasal congestion to recur or

worsen

Frequent or prolonged use may cause nasal congestion to recur or

worsen.
Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 /Rules and Regulations 40649

Until the final rule for the labeling

format proposal is published,

manufacturers, distributors, and

packagers must comply with the final

rule published in this document. The

final rule for the new labeling format

will provide a date by which the

labeling of all OTC nasal decongestant

drug products covered by the

monograph will need to be converted to

the new labeling format.

V. Analysis of Impacts

FDA has examined the impacts of this

final rule under Executive Order 12866

and the Regulatory Flexibility Act (5

U.S.C. 601–612). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts, and equity). Under the

Regulatory Flexibility Act, if a rule has

a significant impact on a substantial

number of small entities, an agency

must analyze regulatory options that

would minimize any significant impact

of a rule on small entities.

Title II of the Unfunded Mandates

Reform Act (2 U.S.C. 1501 et seq.)

requires that agencies prepare a written

statement and economic analysis before

proposing any rule that may result in an

expenditure in any 1 year by State,

local, and tribal governments, in the

aggregate, or by the private sector, of

$100 million (adjusted annually for

inflation). The proposed rule that has

led to the development of this final rule

was published on January 15, 1985 (50

FR 2220), before the Unfunded

Mandates Reform Act was enacted. The

agency explains in this final rule that

the final rule will not result in an

expenditure in any 1 year by State,

local, and tribal governments, in the

aggregate, or by the private sector, of

$100 million.

The agency believes that this final

rule is consistent with the principles set

out in the Executive Order and in these

two statutes. The purpose of this final

rule is to establish conditions under

which OTC nasal decongestant drug

products containing levmetamfetamine

(formerly l-desoxyephedrine) are

generally recognized as safe and

effective. This includes establishing the

allowable monograph labeling.

The March 8, 1996, notice of partial

stay of the OTC nasal decongestant final

monograph included labeling that

manufacturers of OTC topical nasal

decongestant drug products containing

levmetamfetamine (l-desoxyephedrine)

had to have in effect by September 9,

1996. Therefore, all such currently

marketed drug products should have

this labeling in effect. The only labeling

change that is necessary at this time is

to change the established name from ldesoxyephedrine to levmetamfetamine

as a result of the 6th Supplement to USP

23 (Ref. 2). A number of manufacturers

of these products have already made

this change as new labeling needed to

be prepared. The agency believes that an

effective date of 1 year from the date of

this publication will provide

manufacturers of the remaining

products sufficient time to incorporate

the name change during a future

manufacturing cycle. The agency

estimates that there are less than 100

stock keeping units (SKU) (individual

products, packages, and sizes) of

products containing this ingredient

currently in the OTC marketplace. Other

manufacturers who now wish to market

a product containing this ingredient

may enter the marketplace at any time.

The agency considered but rejected

several labeling alternatives: (1) A

longer implementation period, and (2)

an exemption for small entities. The

agency does not consider either of these

approaches acceptable because only a

single labeling change (in the product’s

established name) is needed at this time.

Further, the agency is aware that

manufacturers of products containing

this ingredient already started to change

product labeling after the name change

became official in USP 23.

The analysis shows that this final rule

is not economically significant under

Executive Order 12866 and that the

agency has considered the burden to

small entities. Thus, this economic

analysis, together with other relevant

sections of this document, serves as the

agency’s final regulatory flexibility

analysis, as required under the

Regulatory Flexibility Act. Finally, this

analysis shows that the Unfunded

Mandates Act does not apply to the final

rule because it would not result in an

expenditure in any 1 year by State,

local, and tribal governments, in the

aggregate, or by the private sector, of

$100 million.

VI. Paperwork Reduction Act of 1995

FDA concludes that the labeling

requirements in this document are not

subject to review by the Office of

Management and Budget because they

do not constitute a ‘‘collection of

information’’ under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501

et seq.). Rather, the labeling statements

are a ‘‘public disclosure of information

originally supplied by the Federal

Government to the recipient for the

purpose of disclosure to the public’’ (5

CFR 1320.3(c)(2)).

VII. Environmental Impact

The agency has determined under 21

CFR 25.30(h) that this action is of a type

that is categorically excluded from the

preparation of an environmental

assessment because these actions, as a

class, will not result in the production

or distribution of any substance and

therefore will not result in the

production of any substance into the

environment.

VIII. References

The following references are on

display in the Dockets Management

Branch (address above) and may be seen

by interested persons between 9 a.m.

and 4 p.m., Monday through Friday.

(1) Pharmacopeial Forum, The United

States Pharmacopeial Convention, Inc.,

Rockville, MD, p. 3429, January through

February, 1997.

(2) Sixth Supplement to USP 23 and to NF

18, United States Pharmacopeial Convention,

Inc., Rockville, MD, p. 3631, 1997.

(3) Memorandum from D. Bowen, FDA, to

R. Wolters, FDA representative to USAN

Council, dated January 22, 1997, Docket No.

76N–052N, Dockets Management Branch.

(4) Memorandum from R. Wolters, FDA

representative to USAN Council, to D. Bowen

et al., FDA, dated February 6, 1997, Docket

No. 76N–052N, Dockets Management Branch.

List of Subjects

21 CFR Part 310

Administrative practice and

procedure, Drugs, Labeling, Medical

devices, Reporting and recordkeeping

requirements.

21 CFR Part 341

Labeling, Over-the-counter drugs.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR parts 310

and 341 are amended as follows:

PART 310—NEW DRUGS

1. The authority citation for 21 CFR

part 310 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 355, 357, 360b–360f, 360j, 361(a), 371,

374, 375, 379e; 42 U.S.C. 216, 241, 242(a),

262, 263b–263n.

2. Section 310.545 Drug products

containing certain active ingredients

offered over-the-counter (OTC) for

certain uses is amended in paragraph

(a)(6)(ii)(B) by removing the entry for ‘‘ldesoxyephedrine (topical).’’
40650 Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 /Rules and Regulations

PART 341—COLD, COUGH, ALLERGY,

BRONCHODILATOR, AND

ANTIASTHMATIC DRUG PRODUCTS

FOR OVER–THE–COUNTER HUMAN

USE

3. The authority citation for 21 CFR

part 341 continues to read as follows:

Authority: 21 U.S.C. 321, 351, 352, 353,

355, 360, 371.

4. Section 341.20 is amended by

revising paragraph (b)(1) to read as

follows:

§ 341.20 Nasal decongestant active

ingredients.

* * * * *

(b) * * *

(1) Levmetamfetamine.

* * * * *

5. Section 341.80 is amended by

revising paragraphs (c)(2)(ii), (c)(2)(vii),

and (d)(2)(i), and the heading of

paragraph (d)(2)(viii) to read as follows:

§ 341.80 Labeling of nasal decongestant

drug products.

* * * * *

(c) * * *

(2) * * *

(ii) For products containing

levmetamfetamine identified in

§ 341.20(b)(1) when used in an inhalant

dosage form and when labeled for

adults. ‘‘Do not use this product for

more than 7 days. Use only as directed.

Frequent or prolonged use may cause

nasal congestion to recur or worsen. If

symptoms persist, ask a doctor.’’

* * * * *

(vii) For products containing

levmetamfetamine identified in

§ 341.20(b)(1) when used in an inhalant

dosage form and when labeled for

children under 12 years of age. ‘‘Do not

use this product for more than 7 days.

Use only as directed. Frequent or

prolonged use may cause nasal

congestion to recur or worsen. If

symptoms persist, ask a doctor.’’

* * * * *

(d) * * *

(2) * * *

(i) For products containing

levmetamfetamine identified in

§ 341.20(b)(1) when used in an inhalant

dosage form. The product delivers in

each 800 milliliters of air 0.04 to 0.150

milligrams of levmetamfetamine.

Adults: 2 inhalations in each nostril not

more often than every 2 hours. Children

6 to under 12 years of age (with adult

supervision): 1 inhalation in each

nostril not more often than every 2

hours. Children under 6 years of age:

ask a doctor.

* * * * *

(viii) Other required statements—For

products containing levmetamfetamine

or propylhexedrine identified in

§ 341.20(b)(1) or (b)(9) when used in an

inhalant dosage form. * * *

* * * * *

Dated: July 23, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20303 Filed 7–29–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. 98N–0513]

Medical Devices; Neurological

Devices; Classification of Cranial

Orthosis

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is classifying the

cranial orthosis into class II (special

controls). The special controls that will

apply to the cranial orthosis are

restriction to prescription use,

biocompatibility testing, and certain

labeling requirements. The agency is

taking this action in response to a

petition submitted under the Federal,

Food, Drug, and Cosmetic Act (the act)

as amended by the Medical Device

Amendments of 1976, the Safe Medical

Devices Act of 1990, and the Food and

Drug Administration Modernization Act

of 1997. The agency is classifying

cranial orthosis into class II (special

controls) in order to provide a

reasonable assurance of safety and

effectiveness of the device.

EFFECTIVE DATE: August 31, 1998.

FOR FURTHER INFORMATION CONTACT:

James E. Dillard, Center for Devices and

Radiological Health (HFZ–410), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1184.

SUPPLEMENTARY INFORMATION:

I. Background

In accordance with section 513(f)(1) of

the act (21 U.S.C. 360c(f)(1)), devices

that were not in commercial distribution

before May 28, 1976, the date of

enactment of the Medical Device

Amendments of 1976 (the amendments),

generally referred to as postamendments

devices, are classified automatically by

statute into class III without any FDA

rulemaking process. These devices

remain in class III and require

premarket approval, unless and until

the device is classified or reclassified

into class I or II or FDA issues an order

finding the device to be substantially

equivalent, in accordance with section

513(i) of the act, to a predicate device

that does not require premarket

approval. The agency determines

whether new devices are substantially

equivalent to previously marketed

devices by means of premarket

notification procedures in section 510(k)

of the act (21 U.S.C. 360(k)) and part 807

of the FDA regulations (21 CFR part

807).

Section 513(f)(2) of the act provides

that any person who submits a

premarket notification under section

510(k) of the act for a device that has not

previously been classified may, within

30 days after receiving an order

classifying the device in class III under

section 513(f)(1), request FDA to classify

the device under the criteria set forth in

section 513(a)(1). FDA shall, within 60

days of receiving such a request, classify

the device by written order. This

classification shall be the initial

classification of the device. Within 30

days after the issuance of an order

classifying the device, FDA must

publish a notice in the Federal Register

announcing such classification.

In accordance with section 513(f)(1) of

the act, FDA issued an order on March

12, 1998, classifying the Dynamic

Orthotic Cranioplasty (DOCTM Band) in

class III, because it was not substantially

equivalent to a device that was

introduced or delivered for introduction

into interstate commerce for commercial

distribution before May 28, 1976, or a

device which was subsequently

reclassified into class I or class II. On

March 31, 1998, Cranial Technologies,

Inc., submitted a petition requesting

classification of the DOCTM Band under

section 513(f)(2) of the act. The

manufacturer recommended that the

device be classified into class II.

In accordance with 513(f)(2) of the

act, FDA reviewed the petition in order

to classify the device under the criteria

for classification set forth in 513(a)(1) of

the act. Devices are to be classified into

class II if general controls, by

themselves, are insufficient to provide

reasonable assurance of safety and

effectiveness, but there is sufficient

information to establish special controls

to provide reasonable assurance of the

safety and effectiveness of the device for

its intended use. After review of the

information submitted in the petition

and the medical literature, FDA

determined that the DOCTM Band can be