12162 Federal Register / Vol. 60, No. 43 / Monday, March 6, 1995 / Proposed Rules

§ 105.4 Termination of licenses and

permits for inactivity.

(a) If a biological product has not been

prepared by a licensee, or imported by

a permittee for a period of five years or

more, the Administrator may require the

licensee to show intent to resume

production, or the permittee to show

intent to resume importation, within six

months of notification. If the licensee

does not resume preparation, or the

permittee does not resume importation,

within six months of notification, or

within a mutually agreeable period, the

product license, or permit, may be

terminated by the Administrator.

(b) When a license or permit is

terminated, the licensee or permittee

shall continue to be subject to

applicable records provisions of § 116.8.

10. In 9 CFR part 116, the heading for

the part would be revised to read as

follows:

PART 116—RECORDS AND REPORTS

11. The authority citation for part 116

would continue to read as follows:

Authority: 21 U.S.C. 151–159; 7 CFR 2.17,

2.51, and 371.2(d).

12. In § 116.1, paragraphs (a), (b) and

(c) would be redesignated as paragraphs

(a)(1), (a)(2), and (a)(3), respectively;

redesignated paragraph (a)(1) would be

revised; the introductory paragraph

would be designated as paragraph (a)

and would be revised; and new

paragraphs (b) and (c) would be added

to read as follows:

§ 116.1 Applicability and general

considerations.

(a) Each licensee, permittee, and

foreign manufacturer of biological

products imported into the United

States shall maintain, at the licensed or

foreign establishment in which the

products are prepared, detailed records

of information necessary to give a

complete accounting of all the activities

within such establishment. Such

records shall include, but shall not be

limited to, the items enumerated in this

part.

(1) Records shall be made

concurrently with the performance of

successive steps in the development and

preparation of biological products,

including new products under

development. Such records shall

include the date and where critical, the

time that each essential step was taken,

the identity and quantity of ingredients

added or removed at each step, and any

gain or loss of product from the

beginning to the end of product

preparation.

* * * * *

(b) In the case of imported products,

each permittee shall maintain at the

permittee’s place of business detailed

and accurate records that are relevant to

each imported product and that include,

but are not limited to, importation

documents, sampling records, tests

summaries, shipping records, and

inventory and disposition records as

required in § 116.2.

(c) When authorized by the

Administrator, the licensee, permittee,

or foreign manufacturer may maintain

and retain records required under part

116 at an alternative location. Such

authorization shall be confirmed by the

filing of an addendum to the plot plan

legend. The addendum shall list the

location of the records and the

condition of their storage and shall

permit the inspection of the records by

APHIS inspectors, or foreign inspectors

acting on behalf of APHIS.

(Approved by the Office of Management and

Budget under control number 0579–0013)

§§ 116.2, 116.3, 116.4, and 116.6

[Amended]

13. At the end of §§ 116.2, 116.3,

116.4, and 116.6, the reference to OMB

control number ‘‘0579–0059’’ would be

removed and the number ‘‘0579–0013’’

would be added in its place.

14. Section 116.5 would be revised to

read as follows:

§ 116.5 Reports.

(a) When required by the

Administrator, reports containing

accurate and complete information

concerning biological products,

including but not limited to, product

development and preparation, consumer

reports, and market suspensions and

recalls, shall be prepared and submitted

to the Animal and Plant Health

Inspection Service by the licensee,

permittee, or foreign manufacturer

whose products are being imported or

offered for importation. Unless

otherwise authorized by the

Administrator, records necessary to

make such reports shall be maintained

in each establishment.

(b) If, at any time, consumer reports

concerning the use of products raise

questions regarding purity, safety,

potency, or efficacy of the products; or

a biological product appears to be

unsatisfactory or is found to have been

prepared, tested, or distributed in

violation of the Virus-Serum-Toxin Act

or the regulations; the licensee,

permittee, or foreign manufacturer shall

immediately report the circumstances

and the action taken, if any, to the

Animal and Plant Health Inspection

Service.

(Approved by the Office of Management and

Budget under control number 0579–0013)

15. In § 116.7, the second sentence

would be revised to read as follows:

§ 116.7 Test records.

* * * Summaries of such tests shall

be prepared from such records and

submitted to the Animal and Plant

Health Inspection Service using APHIS

Form 2008 or an acceptable equivalent

form prior to release of the serial or

subserial. * * *

* * * * *

16. Section 116.8 would be revised to

read as follows:

§ 116.8 Completion and retention of

records.

All records (other than disposition

records) required by this part shall be

completed by the licensee, permittee, or

foreign manufacturer before any portion

of a serial of any product may be

marketed in the United States or

exported. All records shall be retained

at the licensed or foreign establishment

or permittee’s place of business for a

period of two years after the expiration

date of a product, or for such longer

period as may be required by the

Administrator.

(Approved by the Office of Management and

Budget under control number 0579–0013)

Done in Washington, DC, this 28th day of

February 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 95–5406 Filed 3–3–95; 8:45 am]

BILLING CODE 3410–34–M

9 CFR Parts 102 and 114

[Docket No. 93–136–1]

Viruses, Serums, Toxins, and

Analogous Products; State-Federal

Licensure of Veterinary Biologics

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Proposed rule.

SUMMARY: We are proposing to amend

the regulations concerning State-Federal

licensing of veterinary biological

products. The effect of the amendment

would be that a Federally licensed

establishment would not be allowed to

produce the same veterinary biological

product under both a State and Federal

product license. Autogenous biologics

would not be subject to the same

requirement, in that a Federally licensed

establishment could hold both State and

Federal product licenses for autogenous

biologics, but must choose to produce

each specific serial of such biologic
Federal Register / Vol. 60, No. 43 / Monday, March 6, 1995 / Proposed Rules 12163

under either a State or Federal product

license. No autogenous biologic could

be produced at the same time under

both a Federal and State license. The

amendment is necessary in order to

ensure the integrity of the Federal

licensing system and the safety of

biological products produced in

Federally licensed establishments.

We are also removing outdated

sections from the regulations referring to

interim establishment licenses and

exemption procedures that were

permitted during the 5-year transition

period to attain Federal licensure under

the 1985 amendments to the VirusSerum-Toxin Act.

DATES: Consideration will be given only

to comments received on or before May

5, 1995.

ADDRESSES: Please send an original and

three copies of your comments to

Docket No. 93–136–1, Animal and Plant

Health Inspection service, Regulatory

Analysis and Development, Program

and Policy Development, 4700 River

Road Unit 118, Riverdale, MD 20737–

1238. Please state that your comments

refer to Docket No. 93–136–1.

Comments received may be inspected at

USDA, room 1141, South Building, 14th

Street and Independence Avenue SW.,

Washington, DC, between 8 a.m. and

4:30 p.m., Monday through Friday,

except holidays. Persons wishing to

inspect comments are requests to call

ahead on (202) 690–2817 to facilitate

entry into the comment reading room.

FOR FURTHER INFORMATION CONTACT:

Dr. David A. Espeseth, Deputy Director,

Veterinary Biologics, BBEP, APHIS,

USDA, 4700 River Road Unit 148,

Riverdale, MD 20723–1237, (301) 734–

8245.

SUPPLEMENTARY INFORMATION:

Background

The Animal and Plant Health

Inspection Service (APHIS), U.S.

Department of Agriculture, licenses

veterinary biological products under the

Virus-Serum-Toxin Act (21 U.S.C. 151–

159, hereinafter, the Act), as amended

by the Food Security Act of 1985.

Veterinary biologics licensed by APHIS

include products such as vaccines,

antitoxins, viruses, diagnostics, and

autogenous biologics (vaccines,

bacterins, and toxoids) which are

normally used in the herd of origin (the

herd from which the disease causing

microorganism is derived) to immunize

animals against infectious disease.

Under the Act, veterinary biological

products are licensed on the basis of

their purity, safety, potency, and

efficacy. The 1985 amendments to the

Act exempt certain products from the

requirement that they be produced

pursuant to an unsuspended and

unrevoked Federal license. Such

products include those which are

prepared solely for distribution within

the State of production pursuant to a

license granted by such State under a

program approved by the Administrator

of APHIS.

The regulations in 9 CFR part 102

contain Federal licensing provisions for

biological products. This proposed rule

would amend the regulations in part

102 by removing the outdated reference

to Federal interim licenses in § 102.1

and by removing § 102.4(h), which

refers to outdated provisions. We would

also be making minor editorial changes

to § 102.4(b)(3) and § 102.6

(introductory paragraph and paragraph

(a)) to reflect organizational changes

within APHIS.

The regulations in 9 CFR part 114

prescribe conditions under which an

unlicensed product may be prepared in

a USDA-licensed establishment. Section

114.2(c) prohibits the production of

unlicensed veterinary biological

products in licensed establishments,

except when an establishment is

licensed by USDA for an interim period

as provided in § 114.2(b), when

production of an experimental

biological product is authorized in

accordance with 9 CFR part 103, or

when biological products are subject to

the provisions of § 107.2 (products

produced under State license).

The proposed rule would amend part

114 by removing from § 114.2

paragraphs (b) and (d) which refer to

outdated provisions for interim licenses

and to certain exemption procedures

that were used in implementing the 5-

year transition to Federal licensure

under the 1985 amendments to the

Virus-Serum-Toxin Act.

The proposed rule would also

establish the conditions that must be

maintained when a State-licensed

veterinary biological product is

produced in an establishment holding a

U.S. Veterinary Biologics Establishment

License. The proposed rule would

require that an establishment holding a

U.S. Veterinary Biologics Establishment

License that is also producing products

licensed by a State may produce a

product either under a U.S. Veterinary

Biological Product License or a State

product license, but the establishment

cannot produce the same product under

both USDA and State product licenses.

It should be noted that in order to be

Federally licensed, an establishment

must hold at least one Federal product

license. Autogenous biologics would not

be subject to the proposed requirement

in that an establishment may hold both

a State and Federal product license for

autogenous biologics but each serial of

an autogenous biologic must either be

produced pursuant to the State license

or the Federal license. The wide variety

of different autogenous biologics that

are made and the different conditions

for their use dictate the need for

choosing to produce some of these

products under a State product license

and others under a USDA product

license. This choice would permit such

establishments to produce autogenous

biologics for intrastate use only, under

a State product license, or for both

intrastate or interstate use, under a U.S.

Veterinary Biological Product License,

provided that certain conditions of

production are maintained. This

proposed rule would define such

conditions and ensure that the primary

regulatory responsibility for each serial

of product is clearly identified prior to

production.

Under the proposed amendments, a

biological product produced in a USDAlicensed establishment could be

produced under either a State or U.S.

Veterinary Biological Product License,

but not both. Prior to the issuance of a

U.S. Veterinary Biological Product

License (including a conditional

license), any State product license for

the same product would have to be

surrendered to the State licensing

authority. As explained previously,

autogenous biologics would not be

subject to these requirements.

Under the proposed amendments,

State-licensed products (including

autogenous biologics) would only be

allowed to be distributed or shipped

intrastate, would not be allowed to bear

a U.S. Veterinary Biological Product

License Number, or otherwise be

represented as having met the

requirements for USDA product

licensure. Labeling of State- and USDAlicensed products produced in the same

establishment would be required to be

distinctly different in color and design.

All biological products in USDAlicensed establishments, whether Stateor USDA-licensed, would only be

prepared in locations indicated in

legends filed in accordance with 9 CFR

part 108. A description of each Statelicensed product would have to be filed

with APHIS as part of the blueprint

legends that is sufficient for APHIS to

determine any risk to other products in

the establishment and to ensure that

contamination does not occur during

production.

The proposed amendments would

also specify that certain reporting and

recordkeeping requirements have to be

met for both State- and USDA-licensed

products.
12164 Federal Register / Vol. 60, No. 43 / Monday, March 6, 1995 / Proposed Rules

The proposed amendments under

§ 114.2(c) would require that

autogenous biological products

produced in a USDA-licensed

establishment be identified as produced

under the provisions of the State license

or the Federal license at the time that a

culture of microorganisms (the isolate)

is received at the establishment. If, after

producing the product pursuant to one

license, the licensee elects to produce

an autogenous biologic from the same

isolate under the other license, approval

of the other licensing authority would

have to be obtained.

In addition, the proposed amendment

would require that a State-licensed

autogenous biologic prepared in a

Federally licensed establishment bear a

‘‘true name’’ indicating the State of

licensure, such as ‘‘(name of State)

Autogenous Bacterin’’ or ‘‘(name of

State) Autogenous Vaccine.’’

Executive Order 12866 and Regulatory

Flexibility Act

This proposed rule has been reviewed

under Executive Order 12866. The rule

has been determined to be not

significant for purposes of Executive

Order 12866, and, therefore, has not

been reviewed by the Office of

Management and Budget.

The effect of the proposed rule would

be to remove outdated sections from the

regulations in §§ 102.1 and 102.4(h) and

§ 114.2 (b) and (d). These sections refer

to outdated provisions related to the

implementation of the 1985

amendments to the Virus-Serum-Toxin

Act. These provisions expired on June

30, 1991.

The proposed rule would also

establish conditions applicable to some

100 producers to prepare a biological

product under either a State or USDA

product license in a USDA licensed

establishment. An exception would be

provided for autogenous biologics. The

proposed amendment would not have

an adverse economic impact on these

producers of biologics since it would

still allow the production of both State

and Federally licensed products in

Federally licensed establishments.

Therefore, it is not anticipated that the

amendment would impose economic

burdens on producers or small

businesses.

Under these circumstances, the

Administrator of the Animal and Plant

Health Inspection Service has

determined that this action would not

have a significant economic impact on

a substantial number of small entities.

Executive Order 12372

This program/activity is listed in the

Catalog of Federal Domestic Assistance

under No. 10.025 and is subject to

Executive Order 12372, which requires

intergovernmental consultation with

State and local officials. (See 7 CFR part

3015, subpart V.)

Executive Order 12778

This proposed rule has been reviewed

under Executive Order 12778, Civil

Justice Reform. If this proposed rule is

adopted: (1) All State and local laws and

regulations that are in conflict with this

rule will be preempted; (2) no

retroactive effect will be given to this

rule; and (3) administrative proceedings

will not be required before parties may

file suit in court challenging this rule.

Paperwork Reduction Act

This document contains no new

information collection or recordkeeping

requirements under the Paperwork

Reduction Act of 1980 (44 U.S.C. 3501

et seq.).

List of Subjects

9 CFR Part 102

Animal biologics, Reporting and

recordkeeping requirements.

9 CFR Part 114

Animal biologics, Reporting and

recordkeeping requirements.

Accordingly, 9 CFR parts 102 and 114

would be amended as follows:

PART 102—LICENSES FOR

BIOLOGICAL PRODUCTS

1. The authority citation for part 102

would continue to read as follows:

Authority: 21 U.S.C. 151–159; 7 CFR 2.17,

2.51, and 371.2(d).

§ 102.1 [Revised]

2. Section 102.1 would be revised to

read as follows:

Each establishment qualified to

prepare biological products under the

Virus-Serum-Toxin Act shall hold an

unexpired and unrevoked U.S.

Veterinary Biologics Establishment

License issued by the Administrator and

a U.S. Veterinary Biological Product

License for each product prepared in

such establishment unless the product

is subject to the provisions of 9 CFR

parts 103 or 106 of this subchapter.

§ 102.4 [Amended]

3. In § 102.4, paragraph (b)(3), the

words ‘‘Veterinary Services’’ are

removed and the words ‘‘Animal and

Plant Health Inspection Service’’ are

added in their place.

4. In § 102.4, paragraph (h) would be

removed.

§ 102.6 [Amended]

5. In § 102.6, in the introductory

paragraph and paragraph (a), the term

‘‘Deputy’’ is removed.

PART 114—PRODUCTION

REQUIREMENTS FOR BIOLOGICAL

PRODUCTS

6. The authority citation for part 114

would be revised to read as follows:

Authority: 21 U.S.C. 151–159; 7 CFR 2.17,

2.51, and 371.2(d).

7. Section 114.2, paragraphs (b) and

(d) would be removed; paragraph (c)

would be redesignated paragraph (b)

and revised; and a new paragraph (c)

would be added to read as follows:

§ 114.2 Products not prepared under

license.

* * * * *

(b) Except as provided in 9 CFR part

103, a biological product shall not be

prepared in a licensed establishment

unless the person to whom the

establishment license is issued holds an

unexpired, unsuspended, and

unrevoked product license issued by the

Administrator to prepare such biological

product, or unless the products

prepared are subject to the provisions of

§ 107.2 of this subchapter.

(c) A biological product produced in

a USDA-licensed establishment shall be

produced under a U.S. Veterinary

Biological Product License or a License

granted by a State under § 107.2

(referred to as a State biological product

license and the products prepared

pursuant thereto as State-licensed

biological products, including

autogenous biologics), but not under

both a U.S. Veterinary Biological

Product License and a State biological

product license. Before a U.S.

Veterinary Biological Product License

(including a conditional license) is

issued, the licensee shall relinquish its

State license for that product: Provided,

That autogenous biologics shall not be

subject to this provision when they are

prepared in accordance with the

provisions of paragraph (c)(5) of this

section.

(1) State-licensed biological products

(including autogenous biologics) shall

only be distributed or shipped

intrastate, must not bear a U.S.

Veterinary Biologics Establishment

License Number, and must not

otherwise be represented in any manner

as having met the requirements for a

U.S. Veterinary Biological Product

license. Labeling of State- and USDAlicensed biological products produced

in the same establishment must be

distinctly different in color and design.
Federal Register / Vol. 60, No. 43 / Monday, March 6, 1995 / Proposed Rules 12165

(2) All biological products in USDAlicensed establishments, whether

licensed by USDA or by the State, shall

be prepared only in locations indicated

in legends filed in accordance with 9

CFR part 108. A description of each

State-licensed product must be filed

with the Animal and Plant Health

Inspection Service as part of the

blueprint legends and must be sufficient

for Animal and Plant Health Inspection

Service to determine any risk to the

production of other products in the

licensed establishment and to determine

that adequate procedures are followed

to prevent contamination during

production.

(3) Records in such establishments

must be maintained in accordance with

§§ 116.1 and 116.2 of this subchapter

and shall include all products licensed

by the State or USDA.

(4) Reports prescribed in § 116.5 of

this subchapter for USDA-licensed

establishments shall be submitted for all

veterinary biological products in the

establishment.

(5) Under the following conditions, an

autogenous biologic may be produced in

a USDA-licensed establishment under

either a State or U.S. Veterinary

Biological Product License:

(i) When a culture of microorganisms,

isolated from a herd in a State, is

received at a USDA-licensed

establishment that is in the same State

but that holds both a State and a U.S.

Veterinary Biological Products License

for autogenous biologics, the isolate

shall be designated by the licensee for

use in the production of an autogenous

biological product under either the State

product license, or the U.S. Veterinary

Biological Product License: Provided,

That the isolate meets the requirements

of the respective regulatory authority for

an autogenous biologic. If, after

producing the product pursuant to one

license, the licensee elects to produce

an autogenous biologic from the same

isolate under provisions of the other

license, the licensee may do so only

with the approval of the other licensing

authority.

(ii) The true name of a State-licensed

autogenous biologic shall specify the

State of licensure: e.g. ‘‘(State)

Autogenous Bacterin’’ or ‘‘(State)

Autogenous Vaccine’’.

Done in Washington, DC, this 28th day of

February 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 95–5407 Filed 3–3–95; 8:45 am]

BILLING CODE 3410–34–M

CONSUMER PRODUCT SAFETY

COMMISSION

16 CFR Part 1700

Requirements for the Special

Packaging of Household Substances;

Opportunity for Oral Comment

AGENCY: Consumer Product Safety

Commission.

ACTION: Opportunity for presentation of

oral public comments.

SUMMARY: The Commission announces

an opportunity for the presentation of

oral comments on two issues that were

recently raised concerning amendments

the Commission is considering to its

regulations under the Poison Prevention

Packaging Act of 1970 (PPPA) for childresistant packaging to change the child

and adult tests under which childresistant packaging is evaluated.

Immediately after issuing a rule

amending the PPPA test protocol, the

Commission was provided with

comments on the final rule that had not

previously been submitted to the agency

during the course of the rulemaking. As

a result, the Commission, on February 9,

1995, voted to withhold publication of

the final rule in order to consider these

new arguments.

The new arguments can be

summarized as follows. First, in

establishing an adult test panel

consisting of adults aged 60–75, the

Commission allegedly exceeded its

statutory authority to require that childresistant packaging not be difficult for

‘‘normal adults’’ to use properly.

Second, the rule allegedly addresses

consumer convenience, rather than

safety, which the comment claims is not

properly the subject of a Commission

regulation.

The Commission has provided that

written comments, limited to these two

issues, may be submitted until March 7,

1995. In addition, the Commission is

providing the opportunity for interested

parties to present oral comments, on

these two issues alone, limited to a

maximum of 10 minutes per

commenter.

DATES: Oral comments limited to the

new issues described below may be

presented to the Commission at a

Commission hearing beginning at 10:00

a.m., March 16, 1995. A request to

present oral comments and an outline or

text of the comments must be received

by the Commission on or before March

10, 1995.

ADDRESSES: The hearing will be held in

the Commission’s Hearing Room, 4330

East-West Highway, 4th Floor, Bethesda,

MD 20814. Requests to present

comments and outlines or text of the

comments should be mailed to the

Office of the Secretary, Consumer

Product Safety Commission,

Washington, DC 20207, or delivered to

the Office of the Secretary, Consumer

Product Safety Commission, Room 501,

4340 East-West Highway, Bethesda, MD

20814.

FOR FURTHER INFORMATION CONTACT:

Suzanne Barone, Ph.D., Project

Manager, Consumer Product Safety

Commission, Washington, DC 20207;

telephone (301) 504–0477, ext. 1196.

SUPPLEMENTARY INFORMATION: The

Poison Prevention Packaging Act of

1970 (‘‘PPPA’’), 15 U.S.C. 1471–1476,

authorizes the Consumer Product Safety

Commission to issue requirements that

certain household substances be sold in

child-resistant (‘‘CR’’) packaging. Under

the PPPA, the Commission has defined

and established standards for such

‘‘special’’ packaging. 16 CFR

1700.1(b)(4), 1700.3, 1700.15, and

1700.20. The Commission has also

determined which household

substances are required to have the

special packaging. 16 CFR 1700.14.

Congress provided that to comply

with the special packaging

requirements, a package must resist

entry by most young children and must

be ‘‘not difficult’’ for ‘‘normal adults’’ to

open and properly resecure, within

specified time periods. 15 U.S.C.

1471(4). The Commission’s existing

regulations were developed before the

widespread use of CR packaging

(‘‘CRP’’) and, therefore, without the

benefit of the actual use experience and

test data that since have become

available.

The current adult test protocol, 16

CFR 1700.20(a) (4) and (5), specifies a

test panel of 100 adults, ages 18 through

45 years. Seventy percent of the adults

must be females and 30 percent must be

males. The test period is 5 minutes. The

adults are given the test package and

asked to open and then properly close

the package. For a package to meet the

PPPA effectiveness criteria, at least 90

percent of the adults must be able to

open and, if appropriate, properly close

the package within the 5-minute test

period. 16 CFR 1700.15(b)(2).

Although the PPPA has significantly

reduced the number of poisonings of

young children, deaths and injuries

resulting from these accidental

ingestions continue to be a substantial

problem. For example, in 1993 alone,

approximately 140,000 children under 5

years old were treated in hospital

emergency rooms for suspected or

actual poisonings. Also in 1993, poison

control centers received reports of more