Federal Register / Vol. 63, No. 98 /Thursday, May 21, 1998 / Proposed Rules 27885

1The Commission voted 2–0 to propose clarifying

the enforcement policy statement. Commissioners

Mary Gall and Thomas Moore voted in favor of

issuing the proposal. Chairman Ann Brown

abstained.

Diagram 2

* * * * *

Dated: May 12, 1998.

Sadye E. Dunn,

Secretary, Consumer Product Safety

Commission.

References

The following documents contain

information relevant to this rulemaking

proceeding and are available for inspection at

the Office of the Secretary, Consumer

Product Safety Commission, Room 502, 4330

East-West Highway, Bethesda, Maryland:

1. Memorandum from Margaret Neily,

Project Manager, Directorate for Engineering,

to the Commission, ‘‘Children’s Sleepwear

Flammability Standards—Technical

Amendments,’’ April 27, 1998.

2. Report from C. Craig Morris, Ph.D.,

Directorate for Epidemiology and Health

Sciences, ‘‘Clothing-Related Thermal Burns

in Children Under 15 Years Old.’’ March

1998.

3. Memorandum from Margaret Neily,

Project Manager, Directorate for Engineering,

to File, ‘‘Technical Amendments of the

Children’s Sleepwear Flammability

Standards—Snug-fitting’’ Requirements,

March 31, 1998.

4. Memorandum from Terrance R. Karels,

Directorate for Economic Analysis, to

Margaret Neily, Project Manager, ‘‘Children’s

Sleepwear Update,’’ April 9, 1998.

5. Memorandum from Terrance R. Karels,

Directorate for Economic Analysis, to

Margaret Neily, Project Manager, ‘‘Economic

Considerations of Revisions to the Children’s

Sleepwear Standard,’’ April 9, 1998.

6. Memorandum from Patricia Fairall,

Program Manager to Margaret Neilly, Project

Manager, ‘‘Industry Request for clarification

of sleepwear segregation of tight-fitting

garments,’’ March 3, 1998.

7. Carolyn Meiers, Directorate for

Engineering, to Margaret Neily, Project

Manager, ‘‘Methodology for Structured

Sleepwear Observations,’’ March 31, 1998.

8. ASTM Standards D4910–95a and

D5826–95.

9. Anthropometry of Infants, Children, and

Youths to Age 18 for Product Safety Design.

Highway Safety Research Institute. Ann

Arbor, Michigan: University of Michigan

(1977).

10. Log of February 18, 1998 meeting,

prepared by Margaret Neily, ‘‘Children’s

Sleepwear—snug-fitting requirements,’’

March 4, 1998.

11. Memorandum from Linda Fansler,

Division of Engineering, Lab Sciences, to

Margaret Neily, Project Manager,

‘‘Tolerance,’’ April 8, 1998.

[FR Doc. 98–13026 Filed 5–20–98; 8:45 am]

BILLING CODE 6355–01–P

CONSUMER PRODUCT SAFETY

COMMISSION

16 CFR Parts 1615 and 1616

Proposed Clarification of Statement of

Policy; Standard for the Flammability

of Children’s Sleepwear: Sizes 0

Through 6X; Standard for the

Flammability of Children’s Sleepwear:

Sizes 7 Through 14

AGENCY: Consumer Product Safety

Commission.

ACTION: Proposed clarification of

statement of policy.

SUMMARY: The Commission proposes to

amend the policy statements on the

flammability of children’s sleepwear so

that infant garments (sized for a child

nine months and under) and ‘‘tightfitting’’ garments (as defined in the

sleepwear standards) can be marketed

and promoted with other sleepwear.1

DATES: Written comments concerning

this proposed amendment are due not

later than August 4, 1998.

ADDRESSES: Comments should be

mailed to the Office of the Secretary,

Consumer Product Safety Commission,

Washington, D.C. 20207; telephone:
27886 Federal Register / Vol. 63, No. 98 /Thursday, May 21, 1998 / Proposed Rules

(301) 504–0800 or delivered to the

Office of the Secretary, Room 501, 4330

East-West Highway, Bethesda, Maryland

20814. Copies should be submitted in

five copies and captioned ‘‘Sleepwear

Policy Statement.’’ Comments may also

be filed by telefacsimile to (301) 504–

0127 or by e-mail to cpsc os@cpsc.gov.

FOR FURTHER INFORMATION CONTACT:

Patricia Fairall, Program Manager,

Office of Compliance, Consumer

Product Safety Commission,

Washington, D.C. 20207; telephone

(301) 504–0400, extension 1369.

SUPPLEMENTARY INFORMATION:

A. Background

The Consumer Product Safety

Commission enforces two flammability

standards for children’s sleepwear. The

flammability standard for children’s

sleepwear in sizes 0 through 6X is

codified at 16 CFR Part 1615. The

flammability standard for children’s

sleepwear in sizes 7 through 14 is

codified at 16 CFR Part 1616.

On September 9, 1996, the

Commission issued a final rule

amending the flammability standards

for children’s sleepwear to exclude from

the definition of ‘‘children’s sleepwear,’’

codified at 16 CFR 1615.1(a) and

1616.2(a), (1) garments sized for infants

nine months of age or younger and (2)

tight-fitting garments for children older

than nine months. 61 FR 47634. The

Commission found that such tightfitting garments did not present an

unreasonable risk of injury. Rather, the

Commission’s information showed that

many severe incidents occurred with

loose-fitting garments such as oversized

t-shirts used inappropriately as

sleepwear. The Commission concluded

that garments fitting closely and that

touch the body at key points should be

exempt from the sleepwear standards

because they do not present the same

risk as loose-fitting garments. These

amendments became effective on

January 1, 1997. However, the

Commission also issued a stay of

enforcement for close-fitting garments

which are labeled and promoted as

underwear. That stay expires on June 9,

1998.

B. Clarification

The Commission has become aware

that the garment industry is concerned

about the policy statements in 16 CFR

1615.64(d) and 1616.65(d), which

suggest segregation of items covered by

the children’s sleepwear standards from

all fabrics and garments that are beyond

the scope of the children’s sleepwear

standards. The purpose of the

September 9, 1996 final rule was to

allow garments sized for a child nine

months and under and tight-fitting

garments in sizes above nine months to

be sold and used as sleepwear.

Therefore, the Commission proposes to

modify the policy statements at

1615.64(d) and 1616.65(d) to provide

that infant garments (defined in the

amended sleepwear standard at 16 CFR

1615.1(c)(1) as sized for a child nine

months and under) and ‘‘tight-fitting’’

garments (defined in the amended

sleepwear standard at 16 CFR 1615.1(o)

and 1616.2(m)) can be marketed and

promoted with other sleepwear.

For the reasons stated above and

pursuant to the authority of Section 4 of

the Flammable Fabrics Act (15 U.S.C.

1193), the Commission proposes to

amend 16 CFR 1615.64 and 1616.65 to

read as follows:

PART 1615—STANDARD FOR THE

FLAMMABILITY OF CHILDREN’S

SLEEPWEAR: SIZES 0 THROUGH 6X

1. The authority citation for part 1615

continues to read as follows:

Authority: Sec. 4, 67 Stat. 112, as

amended, 81 Stat. 569–70; 15 U.S.C. 1193.

2. Section 1615.64 is amended by

revising paragraph (d) introductory text

to read as follows:

§ 1615.64 Policy to clarify scope of the

standard.

* * * * *

(d) Retailers, distributors, and

wholesalers, as well as manufacturers,

importers, and other persons (such as

converters) introducing a fabric or

garment into commerce which does not

meet the requirements of the

flammability standards for children’s

sleepwear, have an obligation not to

promote or sell such fabric or garment

for use as an item of children’s

sleepwear. Also, retailers, distributors,

and wholesalers are advised not to

advertise, promote, or sell as an item of

children’s sleepwear any item which a

manufacturer, importer, or other person

(such as a converter) introducing the

item into commerce has indicated by

label, invoice, or, otherwise, does not

meet the requirements of the children’s

sleepwear flammability standards and is

not intended or suitable for use as

sleepwear. ‘‘Infant garments’’ as defined

by § 1615.1(c) and ‘‘tight-fitting’’

garments as defined by § 1615.1(o) are

exempt from the standard which

requires flame resistance. They may be

marketed as sleepwear for purposes of

this section. Additionally, retailers are

advised:

* * * * *

PART 1616—STANDARD FOR THE

FLAMMABILITY OF CHILDREN’S

SLEEPWEAR: SIZES 7 THROUGH 14

1. The authority citation for part 1616

continues to read as follows:

Authority: Sec. 4, 67 Stat. 112, as

amended, 81 Stat. 569–70; 15 U.S.C. 1193.

2. Section 1616.65 is amended by

revising paragraph (d) introductory text

to read as follows:

§ 1616.65 Policy scope of the standard.

* * * * *

(d) Retailers, distributors, and

wholesalers, as well as manufacturers,

importers, and other persons (such as

converters) introducing a fabric or

garment into commerce which does not

meet the requirements of the

flammability standards for children’s

sleepwear, have an obligation not to

promote or sell such fabric or garment

for use as an item of children’s

sleepwear. Also, retailers, distributors,

and wholesalers are advised not to

advertise, promote, or sell as an item of

children’s sleepwear any item which a

manufacturer, importer, or other person

(such as a converter) introducing the

item into commerce has indicated by

label, invoice, or, otherwise, does not

meet the requirements of the children’s

sleepwear flammability standards and is

not intended or suitable for use as

sleepwear. ‘‘Tight-fitting’’ garments as

defined by § 1616.2(m) are exempt from

the standard which requires flame

resistance. They may be marketed as

sleepwear for purposes of this section.

Additionally, retailers are advised:

* * * * *

Dated: May 12, 1998.

Sadye E. Dunn,

Secretary, Consumer Product Safety

Commission.

[FR Doc. 98–13028 Filed 5–20–98; 8:45 am]

BILLING CODE 6355–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 334

[Docket No. 78N–036L]

RIN 0910–AA01

Laxative Drug Products for Over-theCounter Human Use; Proposed

Amendment to the Tentative Final

Monograph

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of proposed rulemaking.