35134 Federal Register / Vol. 63, No. 124 / Monday, June 29, 1998 /Rules and Regulations

(b) If we are not charging you for the

first two hours of search time, under

paragraph (c) of § 402.155, and those

two hours are spent on a computer

search, then the two free hours are the

first two hours of the time needed to

access the information in the computer.

(c) If we are not charging you for the

first 100 pages of duplication, under

paragraph (b) or (c) of § 402.155, then

those 100 pages are the first 100 pages

of photocopies of standard size pages, or

the first 100 pages of computer printout.

* * * * *

[FR Doc. 98–17104 Filed 6–26–98; 8:45 am]

BILLING CODE 4190–29–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 54

[Docket No. 93N–0445]

Financial Disclosure by Clinical

Investigators; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

final rule that appeared in the Federal

Register of February 2, 1998 (63 FR

5233). The document issued regulations

requiring the sponsor of any drug,

including a biological product, or device

marketing application (applicant), to

submit certain information covering the

compensation to, and financial interests

of, any clinical investigator conducting

certain clinical studies. The document

was published with an error. This

document corrects that error.

EFFECTIVE DATE: February 2, 1999.

FOR FURTHER INFORMATION CONTACT:

Mary C. Gross, Office of External

Affairs, Food and Drug Administration

(HF–60), 5600 Fishers Lane, Rockville,

MD 20857, 301–827–3440, FAX 301–

594–0113.

SUPPLEMENTARY INFORMATION: In FR Doc.

98–2407 appearing on page 5233 in the

Federal Register of February 2, 1998,

the following correction is made:

§ 54.4 [Corrected]

On page 5251, in the first column, in

§ 54.4 Certification and disclosure

requirements, paragraph (a), line 3,

‘‘519(k)’’ is corrected to read ‘‘510(k)’’.

Dated: June 19, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–17145 Filed 6–26–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 97F–0440]

Indirect Food Additives: Adjuvants,

Production Aids, and Sanitizers

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

food additive regulations to provide for

the safe use of 1,6-hexanediamine, N, N′-

bis(2,2,6,6-tetramethyl-4-piperidinyl)-,

polymers with morpholine-2,4,6-

trichloro-1,3,5-triazine reaction

products, methylated, as a stabilizer for

olefin polymers intended for use in

contact with food. This action is in

response to a petition filed by Cytec

Industries, Inc.

DATES: The regulation is effective June

29, 1998; written objections and

requests for a hearing by July 29, 1998.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

November 6, 1997 (62 FR 60095), FDA

announced that a food additive petition

(FAP 8B4562) had been filed by Cytec

Industries, Inc., c/o Keller and

Heckman, 1001 G St. NW., suite 500

West, Washington, DC 20001. The

petition proposed to amend the food

additive regulations in § 178.2010

Antioxidants and/or stabilizers for

polymers (21 CFR 178.2010) to provide

for the safe use of 1,6-hexanediamine,

N, N′-bis(2,2,6,6-tetramethyl-4-

piperidinyl)-, polymers with

morpholine-2,4,6-trichloro-1,3,5-triazine

reaction products, methylated, as a

stabilizer for olefin polymers complying

with 21 CFR 177.1520 intended for use

in contact with food.

FDA has evaluated data in the

petition and other relevant material.

Based on this information, the agency

concludes that the proposed use of the

additive is safe and the additive will

achieve its intended technical effect.

Therefore, the regulations in § 178.2010

should be amended as set forth below.

FDA’s review of this petition

indicates that the additive may contain

trace amounts of formaldehyde as an

impurity. The potential carcinogenicity

of formaldehyde was reviewed by the

Cancer Assessment Committee (the

Committee) of FDA’s Center for Food

Safety and Applied Nutrition. The

Committee noted that for many years,

formaldehyde has been known to be a

carcinogen by the inhalation route, but

the Committee concluded that these

inhalation studies are not appropriate

for assessing the potential

carcinogenicity of formaldehyde in

food. The Committee’s conclusion was

based on the fact that the route of

administration (inhalation) is not

relevant to the safety of formaldehyde

residues in food and the fact that tumors

were observed only locally at the portal

of entry (nasal turbinates). In addition,

the agency has received literature

reports of two drinking water studies on

formaldehyde: (1) A preliminary report

of a carcinogenicity study purported to

be positive by Soffritti et al. (1989),

conducted in Bologna, Italy (Ref. 1); and

(2) a negative study by Til et al. (1989),

conducted in The Netherlands (Ref. 2).

The Committee reviewed both studies

and concluded, concerning the Soffritti

study, ‘‘ * * * that data reported were

unreliable and could not be used in the

assessment of the oral carcinogenicity of

formaldehyde’’ (Ref. 3). This conclusion

is based on a lack of critical detail in the

study, questionable histopathological

conclusions, and the use of unusual

nomenclature to describe the tumors.

Based on the Committee’s evaluation,

the agency has determined that there is

no basis to conclude that formaldehyde

is a carcinogen when ingested.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petition and the

documents that FDA considered and

relied upon in reaching its decision to

approve the petition are available for

inspection at the Center for Food Safety

and Applied Nutrition by appointment

with the information contact person

listed above. As provided in § 171.1(h),

the agency will delete from the

documents any materials that are not

available for public disclosure before

making the documents available for

inspection.

The agency has previously considered

the environmental effects of this rule as

announced in the notice of filing for