Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Rules and Regulations 38191

1Alternative shutdown capability is provided by

rerouting, relocating, or modifying existing systems;

dedicated shutdown capability is provided by

installing new structures and systems for the

function of post-fire shutdown.

(i) Reasonably prevent these fires from

occurring;

(ii) Rapidly detect, control, and

extinguish those fires that do occur and

that could result in a radiological

hazard; and

(iii) Ensure that the risk of fireinduced radiological hazards to the

public, environment and plant

personnel is minimized.

(2) The licensee shall assess the fire

protection program on a regular basis.

The licensee shall revise the plan as

appropriate throughout the various

stages of facility decommissioning.

(3) The licensee may make changes to

the fire protection program without NRC

approval if these changes do not reduce

the effectiveness of fire protection for

facilities, systems, and equipment that

could result in a radiological hazard,

taking into account the

decommissioning plant conditions and

activities.

3. In Appendix R, Section I, footnote

1 is removed and footnotes 2 through 5

are redesignated as footnotes 1 through

4, respectively. New footnote 1 to

Section III.G.3, and Section III.M are

revised to read as follows:

Appendix R to Part 50—Fire Protection

Program for Nuclear Power Facilities

Operating Before January 1, 1979

* * * * *

III. Specific Requirements * * *

G. * * *

3. Alternative of dedicated shutdown

capability and its associated circuits,1

independent of cables, systems or

components in the area, room, zone under

consideration should be provided: * * *

* * * * *

M. Fire barrier cable penetration seal

qualification. Penetration seal designs must

be qualified by tests that are comparable to

tests used to rate fire barriers. The acceptance

criteria for the test must include the

following:

1. The cable fire barrier penetration seal

has withstood the fire endurance test without

passage of flame or ignition of cables on the

unexposed side for a period of time

equivalent to the fire resistance rating

required of the barrier;

2. The temperature levels recorded for the

unexposed side are analyzed and

demonstrate that the maximum temperature

is sufficiently below the cable insulation

ignition temperature; and

3. The fire barrier penetration seal remains

intact and does not allow projection of water

beyond the unexposed surface during the

hose stream test.

* * * * *

Dated at Rockville, Maryland, this 14th day

of June, 2000.

For the Nuclear Regulatory Commission.

Annette Vietti-Cook,

Secretary of the Commission.

[FR Doc. 00–15544 Filed 6–19–00; 8:45 am]

BILLING CODE 7590–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 330, 331, 341, 346,

355, 358, 369, and 701

[Docket Nos. 98N–0337, 96N–0420, 95N–

0259, and 90P–0201]

RIN 0910–AA79

Over-the-Counter Human Drugs;

Labeling Requirements; Partial

Extension of Compliance Dates

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; partial extension of

compliance dates.

SUMMARY: The Food and Drug

Administration (FDA) is providing a

partial extension of the compliance

dates for its final rule that appeared in

the Federal Register of March 17, 1999.

The final rule established a

standardized format and standardized

content requirements for the labeling of

over-the-counter (OTC) drug products.

That final rule requires all OTC drug

products to have the new, easy-to-read

format and the revised labeling

requirements within prescribed

implementation periods. This partial

extension provides 1 additional year for

implementation for specific types of

OTC drug products to be in compliance

with the final rule.

DATES:

Effective Date: This rule is effective

July 20, 2000.

Compliance Dates: For compliance

dates, see section III of the

SUPPLEMENTARY INFORMATION section of

this document. Submit written

comments by September 18, 2000.

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:

Gerald M. Rachanow, Center for Drug

Evaluation and Research (HFD–560),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2307.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of March 17,

1999 (64 FR 13254), FDA published a

final rule establishing standardized

format and standardized content

requirements for the labeling of OTC

drug products. Those requirements are

codified in § 201.66 (21 CFR 201.66).

Section 201.66(a) states that the

content and format requirements in

§ 201.66 apply to the labeling of all OTC

drug products. This includes products

marketed under a final OTC drug

monograph, an approved new drug

application (NDA) or abbreviated new

drug application (ANDA) under section

505 of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 355),

and OTC drug products for which there

is no final OTC drug monograph or

approved drug application.

The agency provided different

implementation dates by which OTC

drug products had to be in compliance

with the new requirements. These dates

varied according to the regulatory status

of the products (64 FR 13254 at 13273

and 13274).

A. Products in the OTC Drug Review

Products marketed under final OTC

drug monographs had to comply with

the final rule by April 16, 2001.

Products for which a final monograph

became effective on or after April 16,

1999, had to comply as of: (1) The

applicable implementation date for that

final monograph; (2) the next major

revision to any part of the label or

labeling after April 16, 2001; or (3) April

18, 2005, whichever occurs first.

Combination drug products in which

all of the active ingredients are the

subject of a final monograph or

monographs had to comply with the

final rule as of April 16, 2001.

Combination products in which one or

more active ingredients are the subject

of a final monograph, and one or more

ingredients are still under review as of

the effective date of the final rule, had

to comply as of the implementation date

for the last applicable final monograph

for the combination, or as of April 16,

2001, whichever is earlier. Combination

products in which none of the active

ingredients is the subject of a final

monograph or monographs as of the

effective date of the final rule had to

comply as of: (1) The implementation

date of the last applicable final

monograph for the combination; (2) the

next major revision to any part of the

label or labeling after April 16, 2001; or

(3) April 18, 2005, whichever comes

first.

38192 Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Rules and Regulations

B. Products Marketed Under NDA’s and

ANDA’s

Products that are the subject of an

approved drug application (NDA or

ANDA) before April 16, 1999, had to

comply as of April 16, 2001. Products

that become the subject of an approved

NDA or ANDA on or after April 16,

1999, had to immediately comply with

the final rule.

C. Additional Provisions

Any OTC drug product that was not

described in section I.A and I.B above

had to comply with the final rule as of:

(1) The next major revision to any part

of the label or labeling after April 16,

2001; or (2) April 18, 2005, whichever

occurs first.

Products (including combinations)

marketed under a final OTC drug

monograph or monographs, or under an

NDA or ANDA, with annual sales of less

than $25,000 had to comply with the

final rule as of April 16, 2002. This extra

time was intended to provide marketed

products with a low level of distribution

1 additional year to comply with the

final rule.

Irrespective of the regulatory status of

the product, the agency strongly

encouraged all manufacturers,

distributors, and packers of OTC drug

products to voluntarily implement the

new content and format requirements as

soon as possible, particularly when

existing labeling is exhausted and

relabeling would occur in the normal

course of business. The agency also

encouraged sponsors of products

marketed under NDA’s and ANDA’s to

submit any required labeling

supplements as soon as possible to

ensure timely review.

The agency provided a chart that

summarized the time periods within

which the various categories of

marketed OTC drug products must be in

compliance with the final rule (64 FR

13254 at 13274). Unless otherwise

stated, all time periods in the chart

began on the effective date of the final

rule.

In the Federal Register of April 15,

1999 (64 FR 18571), the agency

published a correction to the final rule

and corrected the effective date from

April 16, 1999, to May 16, 1999. While

the agency did not discuss the

implementation plan and the

compliance dates for the final rule (or

the chart at 64 FR 13274) in this

correction, the correction had the effect

of changing the compliance dates for the

final rule: (1) April 16, 1999, to May 16,

1999; (2) April 16, 2001, to May 16,

2001; (3) April 16, 2002, to May 16,

2002; and (4) April 18, 2005, to May 16,

2005.

II. Citizen Petitions Requesting

Additional Implementation Time

Following publication of the final

rule, the Consumer Healthcare Products

Association (CHPA) and The Cosmetic,

Toiletry, and Fragrance Association

(CTFA) submitted citizen petitions

(Refs. 1 and 2) requesting a 2-year

extension of time for compliance with

the final rule, i.e., extending the May 16,

2001, date to May 16, 2003, and the May

16, 2002, date to May 16, 2004. No

change to the May 16, 2005, date was

requested. CHPA also requested a stay

of the final rule for those products that

had to immediately begin to comply

with the rule (i.e., OTC drug products

approved under an NDA or ANDA after

May 16, 1999) until several

implementation issues described in the

CHPA petition were resolved and

companies were given sufficient time to

incorporate FDA’s clarification into

OTC drug product labeling. The

petitions discussed a number of issues

CHPA and CTFA considered as ‘‘open’’

or pending: (1) The use of columns in

labeling, (2) the protection of trade

dress, (3) the use of type sizes smaller

than 6.0 points, (4) the labeling of single

use and convenience packages or a

categorical small package exemption, (5)

the use of extended text labeling, (6) the

exemption process, and (7) harmonizing

the new ‘‘Drug Facts’’ labeling with

existing cosmetic labeling.

The agency answered these citizen

petitions on February 4, 2000 (Refs. 3

and 4). The agency addressed the issues

that were raised and stated that most of

the issues (columns, the exemption

process, the labeling of single use and

convenience products) had been

addressed or would soon be addressed

through the agency’s guidance process.

One issue (trade dress) had been

addressed through a recent amendment

to the final rule (65 FR 7, January 3,

2000). The agency did not consider the

remaining issues as presenting a

significant obstacle toward industrywide implementation of the final rule,

as demonstrated by the large numbers of

products that are able to comply with

the rule.

III. The Agency’s Final Conclusions

The agency concluded that a stay of

the final rule or a blanket extension of

2 years is excessive and is not consistent

with the public’s interest in having

clear, readable OTC drug product

labeling. Also, recognizing that

guidance documents may prove helpful

to industry in the transition to the new

labeling format, and that the agency

intends to issue at least one more

guidance document (on exemptions and

deferrals), the agency concluded that an

extension of the May 16, 2001, date by

1 year to May 16, 2002 (and a

corresponding extension of the May 16,

2002, date for products with annual

sales of less than $25,000 to May 16,

2003) is justified. The request for a stay

of the final rule for products marketed

under an NDA or ANDA approved after

May 16, 1999, was denied.

The agency is restating below in table

1, the implementation chart that

appeared in the final rule (64 FR 13254

at 13274). This chart is updated to show

the new implementation compliance

dates for the final rule. In addition, the

agency is making one minor change in

the implementation chart. For

combination products subject to an OTC

drug monograph or monographs in

which at least one applicable

monograph was finalized before May 16,

1999, and at least one applicable

monograph is finalized on or after May

16, 1999, the time period is stated as

‘‘Within the period specified in the last

applicable monograph to be finalized, or

by May 16, 2002 (or by May 16, 2003,

if annual sales of the product are less

than $25,000), whichever occurs first.’’

The agency recognizes that some final

monographs may be finalized close to

the May 16, 2002, date. If that occurred,

relabeling might be required at two

closely related time intervals by two

different final rules. The agency would

be aware of that possibility when the

last applicable monograph is published

and would make allowance there to

avoid this dual relabeling within a short

time period. Therefore, the agency is

adding at the end of the time period for

this specific type of combination

product in the implementation chart the

words ‘‘unless the last applicable

monograph to be finalized specifies a

later date.’’ This language should

alleviate any possible ambiguities that

might have existed as to when

relabeling required by two different

rules would have to occur.

Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Rules and Regulations 38193

TABLE 1.—IMPLEMENTATION CHART

Products Time periods

Single entity and combination products subject to drug marketing applications approved before May 16, 1999.By May 16, 2002 (or by May 16, 2003, if annual sales of the product

are less than $25,000).

Single entity and combination products subject to drug marketing applications approved on or after May 16, 1999.Immediately upon approval of the application.

Single entity products subject to an OTC drug monograph finalized before May 16, 1999.By May 16, 2002 (or by May 16, 2003, if annual sales of the product

are less than $25,000).

Single entity products subject to an OTC drug monograph finalized on

or after May 16, 1999.

Within the period specified in the final monograph. However, if a

monograph has not been finalized as of May 16, 2002, then the

product must comply as of the first major labeling revision after May

16, 2002, or by May 16, 2005, whichever occurs first.

Combination products subject to an OTC drug monograph or monographs in which all applicable monographs were finalized before May

16, 1999.

By May 16, 2002 (or by May 16, 2003, if annual sales of the product

are less than $25,000).

Combination products subject to an OTC drug monograph or monographs in which at least one applicable monograph was finalized before May 16, 1999, and at least one applicable monograph is finalized on or after May 16, 1999.Within the period specified in the last applicable monograph to be finalized, or by May 16, 2002 (or by May 16, 2003, if annual sales of the

product are less than $25,000), whichever occurs first, unless the

last applicable monograph to be finalized specifies a later date.

Combination products subject to an OTC drug monograph or monographs in which all applicable monographs are finalized on or after

May 16, 1999.

Within the period specified in the last applicable monograph to be finalized. However, if the last monograph is not finalized as of May 16,

2002, then the product must comply as of the first major labeling revision after May 16, 2002, or by May 16, 2005, whichever occurs

first.

All other single entity and combination OTC drug products (e.g., products in the OTC drug review that are not yet the subject of proposed

OTC drug monographs).

If a monograph has not been finalized as of May 16, 2002, then the

product must comply as of the first major labeling revision after May

16, 2002, or by May 16, 2005, whichever occurs first.

IV. Extension of Compliance Dates for

Other Labeling Revisions

The final rule also contained a

number of other required labeling

revisions in 21 CFR parts 201, 330, 331,

341, 346, 355, 358, 369, and 701 (64 FR

13254 at 13291, 13292, and 13294 to

13297). For any of those labeling

revisions that would have had to be

implemented by May 16, 2001, or May

16, 2002, as a result of complying with

§ 201.66, the agency is also providing a

1-year extension of time for

implementation.

V. Analysis of Impacts

The economic impact of the final rule

was discussed in the final rule (64 FR

13254 at 13276 to 13285. This partial

extension of the compliance dates

provides additional time for companies

to relabel their products and be in

compliance with the final rule. This

extension will also reduce label

obsolescence as companies will have

additional time to use up more existing

labeling. Thus, extending some of the

compliance dates by 1 year will

significantly reduce the economic

impact on industry.

FDA has examined the impacts of this

final rule (partial extension of the

compliance dates) under Executive

Order 12866, the Regulatory Flexibility

Act (5 U.S.C. 601–612), and the

Unfunded Mandates Reform Act of 1995

(Pub. L. 104–4) (2 U.S.C. 1501 et seq.).

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 economic impact on a

substantial number of small entities, an

agency must analyze regulatory options

that would minimize any significant

impact of the rule on small entities.

Title II of the Unfunded Mandates

Reform Act requires that agencies

prepare a written statement and

economic analysis before proposing any

rule that may result in an expenditure

in any one year by State, local, and

tribal governments, in the aggregate, or

by the private sector, of $100 million

(adjusted annually for inflation).

The agency concludes that this final

rule is consistent with the principles set

out in the Executive order and in these

two statutes. This final rule is not a

significant regulatory action as defined

by the Executive order and so is not

subject to review under the Executive

Order. As discussed in this section, FDA

has determined that this final rule will

not have a significant economic impact

on a substantial number of small

entities. Further, because this final rule

makes no mandates on government

entities and will result in expenditures

less than $100 million in any one year,

FDA need not prepare additional

analyses under the Unfunded Mandates

Reform Act.

The purpose of this final rule is to

provide a partial extension of some of

the compliance dates by which

manufacturers need to relabel their

products. This final rule provides 1

additional year to relabel many

products. Accordingly, the agency

certifies that this final rule will not have

a significant economic impact on a

substantial number of small entities.

Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

VI. Good Cause

In its responses to the citizen

petitions (Refs. 3 and 4), the agency set

forth in detail its finding that a stay of

the rule, or a blanket extension of 2

years, is excessive and is not consistent

with the public’s interest in having

clear, readable OTC drug labeling.

However, in recognition of the fact that

there are several pending guidance

documents that may prove helpful in

the transition to the new format, and

that at least one on exemptions and

deferrals has yet to issue, the agency

concluded that an extension of the May

16, 2001, primary implementation date

by 1 year to May 16, 2002 (and the

corresponding implementation date for

products with annual sales less that

$25,000 to May 16, 2003) was justified.

Since the agency is extending the

compliance date of the OTC labeling

final rule based on the citizen petition

responses and because these changes are

nonsubstantive in nature, FDA finds

that notice and comment procedures are

38194 Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Rules and Regulations

unnecessary and not in the public

interest (5 U.S.C. 553(b) and (d)). More

than 3 months have passed since the

agency issued the citizen petition

responses and the agency has received

no adverse correspondence or

comments with respect to its decision.

Therefore, the agency is now amending

the compliance date of the final rule.

However, in accordance with 21 CFR

10.40(e)(1), FDA is providing an

opportunity for comment on whether

this partial extension of the compliance

dates should be modified or revoked.

VII. References

1. Comment No. CP2, Docket No.

98N–0337, Dockets Management

Branch.

2. Comment No. CP1, Docket No.

99P–4617, Dockets Management Branch.

3. Letter from W. K. Hubbard, FDA, to

B. N. Kuhlik and M. S. Labson,

Covington & Burling, coded PAV2,

Docket No. 98N–0337, Dockets

Management Branch.

4. Letter from W. K. Hubbard, FDA, to

E. E. Kavanaugh, CTFA, coded PAV1,

Docket No. 99P–4617, Dockets

Management Branch.

This final rule (partial extension of

compliance dates) is issued under

sections 201, 501, 502, 503, 505, 510,

and 701 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 351, 352,

353, 355, 360, and 371) and under

authority delegated to the Commissioner

of Food and Drugs.

VIII. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

final rule by September 18, 2000. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket numbers

found in brackets in the heading of this

document. Received comments may be

seen in the Dockets Management Branch

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

through Friday.

Dated: June 12, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–15427 Filed 6–19–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

24 CFR Part 985

[Docket No. FR–3986–N–03]

Section 8 Management Assessment

Program (SEMAP); Lifting of Stay of

Certain Regulatory Sections

AGENCY: Office of the Assistant

Secretary for Public and Indian

Housing, HUD.

ACTION: Final rule; lifting of stay.

SUMMARY: On September 10, 1998, HUD

published its final rule for the Section

8 Management Assessment Program

(SEMAP). The final rule took effect

October 13, 1998, and § 985.102

(SEMAP profile); § 985.103 (SEMAP

score and overall performance rating);

§§ 985.105(a), 985.105(b), 985.105(d)

and 985.105(e) (HUD SEMAP

responsibilities); and § 985.107

(Required actions for PHA with troubled

performance rating) were stayed until

further notice. This document lifts the

stay for these sections.

EFFECTIVE DATE: The stay is lifted for 24

CFR 985.102, 0985.103, 985.105(a),

985.105(b), 985.105(d), 985.105(e), and

985.107 as of August 1, 2000.

FOR FURTHER INFORMATION CONTACT:

Gerald J. Benoit, Director, Real Estate

and Housing Performance Division,

Office of Public and Indian Housing,

Department of Housing and Urban

Development, Room 4220, 451 Seventh

Street, SW, Washington, DC 20410–

8000; telephone number (202) 708–0477

(this is not a toll-free telephone

number). Hearing or speech impaired

individuals may access this number via

TTY by calling the toll-free Federal

Information Relay Service at 1–800–

877–8339.

SUPPLEMENTARY INFORMATION: On

September 10, 1998 (63 FR 48548), HUD

published its final rule for the Section

8 Management Assessment Program

(SEMAP). SEMAP provides for objective

measurement of the performance of a

public housing agency (PHA) in key

areas of the Section 8 tenant-based

assistance program. SEMAP enables

HUD to ensure program integrity and

accountability by identifying PHA

management capabilities and

deficiencies and by improving risk

assessment to effectively target

monitoring and program assistance.

PHAs can use the SEMAP performance

analysis to assess their own program

operations.

The ‘‘effective date’’ section of the

September 10, 1998 final rule noted that

the rule took effect October 13, 1998,

with the following sections stayed as of

October 13, 1998, until further notice:

§ 985.102 (SEMAP profile); § 985.103

(SEMAP score and overall performance

rating); paragraphs (a), (b), (d) and (e) of

§ 985.105 (HUD SEMAP

responsibilities), and § 985.107

(Required actions for PHA with troubled

performance rating).

The preamble to the September 10,

1998 SEMAP final rule explained why

these sections were stayed on October

13, 1998. The preamble explained that

HUD would publish a Federal Register

notice of the effective date of the full

implementation of SEMAP when HUD

determined that independent

verification methods for the SEMAP

indicators are properly implemented.

(See 63 FR 48549, first column, second

full paragraph.) HUD has determined

that these methods have been properly

implemented and this document

provides notice that the stay is lifted on

§§ 985.102, 985.103, 985.105(a),

985.105(b), 985.105(d), 985.105(e), and

985.107 as of August 1, 2000.

HUD expects that the first PHAs to be

rated under SEMAP will be PHAs with

fiscal years July 1, 1999 to June 30,

2000. The first ratings are expected to be

assigned in fall 2000.

Dated: June 12, 2000.

Harold Lucas,

Assistant Secretary for Public and Indian

Housing.

[FR Doc. 00–15342 Filed 6–19–00; 8:45 am]

BILLING CODE 4210–33–P

DEPARTMENT OF THE TREASURY

Bureau of Alcohol, Tobacco and

Firearms

27 CFR Parts 47 and 178

[T.D. ATF–426]

RIN 1512–AC02

Implementation of the Model

Regulations for the Control of the

International Movement of Firearms,

Their Parts and Components, and

Ammunition (99R–281P)

AGENCY: Bureau of Alcohol, Tobacco

and Firearms (ATF), Department of the

Treasury.

ACTION: Final rule, Treasury decision.

SUMMARY: This Treasury decision

amends the regulations governing the

importation of firearms, ammunition,

and implements of war. The changes

implement the ‘‘Model Regulations for

the Control of the International

Movement of Firearms, Their Parts and

Components, and Ammunition’’ which