Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26477 

GuidanceComplianceRegulatory

Information/Guidances/default.htm or 

https://www.regulations.gov. 

Dated: June 1, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12217 Filed 6–6–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0781] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Record Retention 

Requirements for the Soy Protein and 

Risk of Coronary Heart Disease Health 

Claim 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(PRA). 

DATES: Fax written comments on the 

collection of information by July 9, 

2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0428. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Record Retention Requirements for the 

Soy Protein and Risk of Coronary Heart 

Disease Health Claim—21 CFR 101.82 

OMB Control Number 0910–0428— 

Extension 

Section 403(r)(3)(A) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

343(r)(3)(A)) provides for the use of food 

label statements characterizing a 

relationship of any nutrient of the type 

required to be in the label or labeling of 

the food to a disease or a health-related 

condition only where that statement 

meets the requirements of the 

regulations issued by the Secretary of 

Health and Human Services to authorize 

the use of such a health claim. Section 

101.82 (21 CFR 101.82) of our 

regulations authorizes a health claim for 

food labels about soy protein and the 

risk of coronary heart disease. 

Accordingly, FDA established the 

previously referenced information 

collection in support of the regulation. 

In the Federal Register of October 31, 

2017 (82 FR 50324), we published a 

proposed rule to revoke the underlying 

regulation found at § 101.82. We are 

taking this action based on our review 

of the totality of publicly available 

scientific evidence currently available 

and our tentative conclusion that such 

evidence does not support our previous 

determination that there is significant 

scientific agreement among qualified 

experts for a health claim regarding the 

relationship between soy protein and 

reduced risk of coronary heart disease. 

Upon finalization of the proposed rule, 

the associated information collection 

requirements under this OMB control 

number will be revoked. Until such time 

and in accordance with the PRA, we 

retain our currently approved burden 

estimate for the information collection 

displayed in table 1 of this notice. 

In the Federal Register of March 8, 

2018 (83 FR 9856), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average 

burden per 

recordkeeping 

Total 

hours 

101.82(c)(2)(ii)(B) ................................................................. 25 1 25 1 25 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on our current experience with 

the use of health claims, we estimate 25 

firms market products bearing a soy 

protein/coronary heart disease health 

claim and that perhaps one of each 

firm’s products might contain non-soy 

sources of protein along with soy 

protein. The records currently required 

to be retained under § 101.82(c)(2)(ii)(B) 

are the records, e.g., the formulation or 

recipe, that a manufacturer has and 

maintains as a normal course of its 

doing business. Thus, the burden to the 

food manufacturer is limited to 

assembling and retaining the records, 

which we estimate will take 1 hour 

annually. 

Dated: May 30, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12216 Filed 6–6–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0961] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Environmental 

Impact Considerations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 


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