80 FR 29719 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 99 (May 22, 2015)

Page Range		29719-29720
FR Document		2015-12402

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.

Federal Register, Volume 80 Issue 99 (Friday, May 22, 2015)

[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29719-29720]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-12402]


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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.

DATES: Fax written comments on the collection of information by June 
22, 2015.

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 [email protected]. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd.; COLE-14526, Silver 
Spring, MD 20993-0002 [email protected].

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(c)(2)(ii)(B)

OMB Control Number 0910-0428--Extension

    Section 403(r)(3)(A) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C.

[[Page 29720]]

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 promulgated 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 (CHD). 
To bear the soy protein and CHD health claim, foods must contain at 
least 6.25 grams of soy protein per reference amount customarily 
consumed. Analytical methods for measuring total protein can be used to 
quantify the amount of soy protein in foods that contain soy as the 
sole source of protein. However, at the present time there is no 
validated analytical methodology available to quantify the amount of 
soy protein in foods that contain other sources of protein. For these 
latter foods, we must rely on information known only to the 
manufacturer to assess compliance with the requirement that the food 
contain the qualifying amount of soy protein. Thus, we require 
manufacturers to have and keep records to substantiate the amount of 
soy protein in a food that bears the health claim and contains sources 
of protein other than soy, and to make such records available to 
appropriate regulatory officials upon written request. The information 
collected includes nutrient databases or analyses, recipes or 
formulations, purchase orders for ingredients, or any other information 
that reasonably substantiates the ratio of soy protein to total 
protein.
    In the Federal Register of March 10, 2015 (80 FR 12640), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the annual burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                           21 CFR section                               Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.82(c)(2)(ii)(B)................................................              25                1               25                1               25
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based upon our experience with the use of health claims, we 
estimate that only about 25 firms would be likely to market products 
bearing a soy protein/coronary heart disease health claim and that 
only, perhaps, one of each firm's products might contain non-soy 
sources of protein along with soy protein. The records required to be 
retained by Sec.  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 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12402 Filed 5-21-15; 08:45 am]
BILLING CODE 4164-01-P

29720 Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices

343(r)(3)(A)) provides for the use of food Analytical methods for measuring total other than soy, and to make such
label statements characterizing a protein can be used to quantify the records available to appropriate
relationship of any nutrient of the type amount of soy protein in foods that regulatory officials upon written
required to be in the label or labeling of contain soy as the sole source of protein. request. The information collected
the food to a disease or a health related However, at the present time there is no includes nutrient databases or analyses,
condition only where that statement validated analytical methodology recipes or formulations, purchase orders
meets the requirements of the available to quantify the amount of soy for ingredients, or any other information
regulations promulgated by the protein in foods that contain other that reasonably substantiates the ratio of
Secretary of Health and Human Services sources of protein. For these latter soy protein to total protein.
to authorize the use of such a health foods, we must rely on information
In the Federal Register of March 10,
claim. Section 101.82 (21 CFR 101.82) of known only to the manufacturer to
our regulations authorizes a health assess compliance with the requirement 2015 (80 FR 12640), FDA published a
claim for food labels about soy protein that the food contain the qualifying 60-day notice requesting public
and the risk of coronary heart disease amount of soy protein. Thus, we require comment on the proposed collection of
(CHD). To bear the soy protein and CHD manufacturers to have and keep records information. No comments were
health claim, foods must contain at least to substantiate the amount of soy received.
6.25 grams of soy protein per reference protein in a food that bears the health We estimate the annual burden of this
amount customarily consumed. claim and contains sources of protein collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of re- Total annual
21 CFR section responses per burden per Total hours
spondents responses
respondent response

101.82(c)(2)(ii)(B) ................................................................. 25 1 25 1 25
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based upon our experience with the SUMMARY: The Food and Drug necessary to gain approval of a new
use of health claims, we estimate that Administration (FDA or Agency) has drug application (NDA).
only about 25 firms would be likely to determined that VAGIFEM (estradiol) The 1984 amendments include what
market products bearing a soy protein/ Vaginal Tablets, 25 micrograms, was not is now section 505(j)(7) of the Federal
coronary heart disease health claim and withdrawn from sale for reasons of Food, Drug, and Cosmetic Act (21 U.S.C.
that only, perhaps, one of each firm’s safety or effectiveness. This
355(j)(7)), which requires FDA to
products might contain non-soy sources determination means that FDA will not
publish a list of all approved drugs.
of protein along with soy protein. The begin procedures to withdraw approval
records required to be retained by of abbreviated new drug applications FDA publishes this list as part of the
§ 101.82(c)(2)(ii)(B) are the records, e.g., (ANDAs) that refer to this drug product, ‘‘Approved Drug Products with
the formulation or recipe, that a and it will allow FDA to continue to Therapeutic Equivalence Evaluations,’’
manufacturer has and maintains as a approve ANDAs that refer to the which is generally known as the
normal course of its doing business. product as long as they meet relevant ‘‘Orange Book.’’ Under FDA regulations,
Thus, the burden to the food legal and regulatory requirements. a drug is removed from the list if the
manufacturer is limited to assembling Agency withdraws or suspends
FOR FURTHER INFORMATION CONTACT:
and retaining the records, which we approval of the drug’s NDA or ANDA
Elaine Lippmann, Center for Drug for reasons of safety or effectiveness or
estimate will take 1 hour annually.
Evaluation and Research, Food and
Dated: May 15, 2015. if FDA determines that the listed drug
Drug Administration, 10903 New
was withdrawn from sale for reasons of
Leslie Kux, Hampshire Ave., Bldg. 51, Rm. 6214,
safety or effectiveness (21 CFR 314.162).
Associate Commissioner for Policy. Silver Spring, MD 20993–0002, 301–
[FR Doc. 2015–12402 Filed 5–21–15; 08:45 am] 796–3602, Elaine.Lippmann@ Under § 314.161(a) (21 CFR
BILLING CODE 4164–01–P fda.hhs.gov. 314.161(a)), the Agency must determine
whether a listed drug was withdrawn
SUPPLEMENTARY INFORMATION: In 1984, from sale for reasons of safety or
DEPARTMENT OF HEALTH AND Congress enacted the Drug Price effectiveness: (1) Before an ANDA that
HUMAN SERVICES Competition and Patent Term refers to that listed drug may be
Restoration Act of 1984 (Pub. L. 98–417) approved, (2) whenever a listed drug is
Food and Drug Administration (the 1984 amendments), which
voluntarily withdrawn from sale and
authorized the approval of duplicate
[Docket No. FDA–2011–P–0482] ANDAs that refer to the listed drug have
versions of drug products approved
under an ANDA procedure. ANDA been approved, and (3) when a person
Determination That VAGIFEM applicants must, with certain petitions for such a determination under
asabaliauskas on DSK5VPTVN1PROD with NOTICES

(Estradiol) Vaginal Tablets, 25 exceptions, show that the drug for 21 CFR 10.25(a) and 10.30. Section
Micrograms, Was Not Withdrawn From which they are seeking approval 314.161(d) provides that if FDA
Sale for Reasons of Safety or contains the same active ingredient in determines that a listed drug was
Effectiveness the same strength and dosage form as withdrawn from sale for safety or
the ‘‘listed drug,’’ which is a version of effectiveness reasons, the Agency will
AGENCY: Food and Drug Administration,
HHS. the drug that was previously approved. initiate proceedings that could result in
ANDA applicants do not have to repeat the withdrawal of approval of the
ACTION: Notice.
the extensive clinical testing otherwise ANDAs that refer to the listed drug.

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Document Created: 2015-12-15 15:45:23
Document Modified: 2015-12-15 15:45:23

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by June 22, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd.; COLE-14526, Silver Spring, MD 20993-0002 [email protected]
FR Citation		80 FR 29719

80 FR 29719 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 99 (May 22, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration