80 FR 12640 - Agency Information Collection Activities; Proposed Collection; 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 46 (March 10, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 46 (March 10, 2015)
| Page Range | 12640-12641 | |
| FR Document | 2015-05504 |
[Federal Register Volume 80, Number 46 (Tuesday, March 10, 2015)] [Notices] [Pages 12640-12641] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-05504] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0781] Agency Information Collection Activities; Proposed Collection; 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. ----------------------------------------------------------------------- [[Page 12641]] SUMMARY: The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice invites comments on the record retention requirements for the soy protein and coronary heart disease health claim. DATES: Submit either electronic or written comments on the collection of information by May 11, 2015. ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, we are publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, we invite comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of our functions, including whether the information will have practical utility; (2) the accuracy of our estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. 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. 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. We estimate the burden of this collection of information as follows: Table 1--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Number of records per Total Average 21 CFR Section recordkeepers annual burden per Total hours recordkeeper records recordkeeping ---------------------------------------------------------------------------------------------------------------- 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: March 4, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-05504 Filed 3-9-15; 8:45 am] BILLING CODE 4164-01-P
![12640 Federal Register / Vol. 80, No. 46 / Tuesday, March 10, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of Average
Number of responses burden per
Type of respondent Form name respondents per response
respondent (in hours)
Underground coal miners ..................................... Informed Consent ................................................. 30 1 5/60
Underground coal miners ..................................... Initial Interviews .................................................... 6 1 1.5
Underground coal miners ..................................... CTA Interviews ..................................................... 12 2 2
Underground coal miners ..................................... Initial focus group sessions .................................. 12 6 1
Underground coal miners ..................................... HTA focus group sessions ................................... 12 6 1
Leroy A. Richardson, Research; 93.209, Contraception and Time: 2:00 p.m. to 4:00 p.m.
Chief, Information Collection Review Office, Infertility Loan Repayment Program, National Agenda: To review and evaluate grant
Office of Scientific Integrity, Office of the Institutes of Health, HHS imposed by the applications.
Associate Director for Science, Office of the review and funding cycle.) Place: National Institutes of Health, 6701
Director, Centers for Disease Control and Dated: March 4, 2015. Rockledge Drive, Bethesda, MD 20892,
Prevention. (Telephone Conference Call).
Michelle Trout, Contact Person: Jay Joshi, Ph.D., Scientific
[FR Doc. 2015–05512 Filed 3–9–15; 8:45 am] Program Analyst, Office of Federal Advisory Review Officer, Center for Scientific Review,
BILLING CODE 4163–18–P Committee Policy. National Institutes of Health, 6701 Rockledge
[FR Doc. 2015–05451 Filed 3–9–15; 08:45 am] Drive, Room 5196, MSC 7846, Bethesda, MD
BILLING CODE 4140–01–P 20892, (301) 408–9135, joshij@csr.nih.gov.
DEPARTMENT OF HEALTH AND Name of Committee: Center for Scientific
HUMAN SERVICES Review Special Emphasis Panel; Member
DEPARTMENT OF HEALTH AND Conflict: Cancer Biology.
National Institutes of Health HUMAN SERVICES Date: April 6, 2015.
Time: 4:00 p.m. to 6:00 p.m.
Eunice Kennedy Shriver National National Institutes of Health Agenda: To review and evaluate grant
Institute of Child Health & Human applications.
Development; Notice of Closed Center for Scientific Review; Notice of Place: National Institutes of Health, 6701
Meeting Closed Meetings Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Pursuant to section 10(d) of the Pursuant to section 10(d) of the Contact Person: Angela Y, Ng, Ph.D.,
Federal Advisory Committee Act, as Federal Advisory Committee Act, as Scientific Review Officer, Center for
amended (5 U.S.C. App.), notice is amended (5 U.S.C. App.), notice is Scientific Review, National Institutes of
hereby given of the following meeting. hereby given of the following meetings. Health, 6701 Rockledge Drive, Room 6200,
The meeting will be closed to the The meetings will be closed to the MSC 7804, Bethesda, MD 20892, 301–435–
public in accordance with the public in accordance with the 1715, nga@csr.nih.gov.
provisions set forth in sections provisions set forth in sections (Catalogue of Federal Domestic Assistance
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Program Nos. 93.306, Comparative Medicine;
as amended. The grant applications and 93.333, Clinical Research, 93.306, 93.333,
as amended. The grant applications and 93.337, 93.393–93.396, 93.837–93.844,
the discussions could disclose the discussions could disclose 93.846–93.878, 93.892, 93.893, National
confidential trade secrets or commercial confidential trade secrets or commercial Institutes of Health, HHS)
property such as patentable material, property such as patentable material,
and personal information concerning Dated: March 4, 2015.
and personal information concerning
individuals associated with the grant individuals associated with the grant David Clary,
applications, the disclosure of which applications, the disclosure of which Program Analyst, Office of Federal Advisory
would constitute a clearly unwarranted would constitute a clearly unwarranted Committee Policy.
invasion of personal privacy. invasion of personal privacy. [FR Doc. 2015–05459 Filed 3–9–15; 8:45 am]
Name of Committee: National Institute of BILLING CODE 4140–01P
Name of Committee: Center for Scientific
Child Health and Human Development Review Special Emphasis Panel; Member
Special Emphasis Panel. Conflict: Diabetes and Obesity.
Date: April 8, 2015. Date: April 2, 2015. DEPARTMENT OF HEALTH AND
Time: 2:00 p.m. to 4:00 p.m. Time: 11:00 a.m. to 6:00 p.m. HUMAN SERVICES
Agenda: To review and evaluate grant Agenda: To review and evaluate grant
applications. applications. Food and Drug Administration
Place: National Institutes of Health, Bldg Place: National Institutes of Health, 6701
6100, 5B01, 6100 Executive Boulevard, Rockledge Drive, Bethesda, MD 20892, [Docket No. FDA–2011–N–0781]
Rockville, MD 20852. (Virtual Meeting).
Contact Person: Sherry L. Dupere, Ph.D., Contact Person: John Bleasdale, Ph.D., Agency Information Collection
Chief, Scientific Review Branch, Scientific Scientific Review Officer, Center for Activities; Proposed Collection;
Review Branch, National Institute of Child Scientific Review, National Institutes of Comment Request; Record Retention
mstockstill on DSK4VPTVN1PROD with NOTICES
Health and Human Development, NIH, 6100 Health, 6701 Rockledge Drive, Room 6170, Requirements for the Soy Protein and
Executive Blvd., RM. 5B01, Bethesda, MD MSC 7892, Bethesda, MD 20892, 301–435– Risk of Coronary Heart Disease Health
20892, (301) 435–6884, duperes@ 4514, bleasdaleje@csr.nih.gov. Claim
mail.nih.gov. Name of Committee: Center for Scientific
(Catalogue of Federal Domestic Assistance Review Special Emphasis Panel; Member AGENCY: Food and Drug Administration,
Program Nos. 93.864, Population Research; Conflict: Neurodegeneration, Neuropathy and HHS.
93.865, Research for Mothers and Children; Neuroinfections. ACTION: Notice.
93.929, Center for Medical Rehabilitation Date: April 2, 2015.
VerDate Sep<11>2014 17:53 Mar 09, 2015 Jkt 235001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\FR\FM\10MRN1.SGM 10MRN1](https://thefederalregister.org/doc/80_FR_12686/page/1.svg)
![Federal Register / Vol. 80, No. 46 / Tuesday, March 10, 2015 / Notices 12641
SUMMARY: The Food and Drug ‘‘Collection of information’’ is defined label statements characterizing a
Administration (FDA or we) is in 44 U.S.C. 3502(3) and 5 CFR relationship of any nutrient of the type
announcing an opportunity for public 1320.3(c) and includes Agency requests required to be in the label or labeling of
comment on the proposed collection of or requirements that members of the the food to a disease or a health related
certain information by the Agency. public submit reports, keep records, or condition only where that statement
Under the Paperwork Reduction Act of provide information to a third party. meets the requirements of the
1995 (the PRA), Federal Agencies are Section 3506(c)(2)(A) of the PRA (44 regulations promulgated by the
required to publish notice in the U.S.C. 3506(c)(2)(A)) requires Federal Secretary of Health and Human Services
Federal Register concerning each Agencies to provide a 60-day notice in to authorize the use of such a health
proposed collection of information, the Federal Register concerning each claim. Section 101.82 (21 CFR 101.82) of
including each proposed extension of an proposed collection of information, our regulations authorizes a health
existing collection of information, and including each proposed extension of an claim for food labels about soy protein
to allow 60 days for public comment in existing collection of information, and the risk of coronary heart disease
response to the notice. This notice before submitting the collection to OMB (CHD). To bear the soy protein and CHD
invites comments on the record for approval. To comply with this health claim, foods must contain at least
retention requirements for the soy requirement, we are publishing notice of 6.25 grams of soy protein per reference
protein and coronary heart disease the proposed collection of information amount customarily consumed.
health claim. set forth in this document. Analytical methods for measuring total
DATES: Submit either electronic or With respect to the following protein can be used to quantify the
written comments on the collection of collection of information, we invite amount of soy protein in foods that
information by May 11, 2015. comments on these topics: (1) Whether contain soy as the sole source of protein.
ADDRESSES: Submit electronic the proposed collection of information However, at the present time there is no
comments on the collection of is necessary for the proper performance validated analytical methodology
information to http:// of our functions, including whether the available to quantify the amount of soy
www.regulations.gov. Submit written information will have practical utility; protein in foods that contain other
comments on the collection of (2) the accuracy of our estimate of the sources of protein. For these latter
information to the Division of Dockets burden of the proposed collection of foods, we must rely on information
Management (HFA–305), Food and Drug information, including the validity of known only to the manufacturer to
Administration, 5630 Fishers Lane, Rm. the methodology and assumptions used; assess compliance with the requirement
1061, Rockville, MD 20852. All (3) ways to enhance the quality, utility, that the food contain the qualifying
comments should be identified with the and clarity of the information to be amount of soy protein. Thus, we require
docket number found in brackets in the collected; and (4) ways to minimize the manufacturers to have and keep records
heading of this document. burden of the collection of information to substantiate the amount of soy
on respondents, including through the protein in a food that bears the health
FOR FURTHER INFORMATION CONTACT: FDA
use of automated collection techniques, claim and contains sources of protein
PRA Staff, Office of Operations, Food when appropriate, and other forms of other than soy, and to make such
and Drug Administration, 8455 information technology. records available to appropriate
Colesville Rd., COLE–14526, Silver regulatory officials upon written
Spring, MD 20993–0002, PRAStaff@ Record Retention Requirements for the request. The information collected
fda.hhs.gov. Soy Protein and Risk of Coronary Heart includes nutrient databases or analyses,
Disease Health Claim—21 CFR recipes or formulations, purchase orders
SUPPLEMENTARY INFORMATION: Under the
101.82(c)(2)(ii)(B) (OMB Control for ingredients, or any other information
PRA (44 U.S.C. 3501–3520), Federal
Number 0910–0428)—Extension that reasonably substantiates the ratio of
Agencies must obtain approval from the
Office of Management and Budget Section 403(r)(3)(A) of the Federal soy protein to total protein.
(OMB) for each collection of Food, Drug, and Cosmetic Act (21 U.S.C. We estimate the burden of this
information they conduct or sponsor. 343(r)(3)(A)) provides for the use of food collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of records Total burden per Total
21 CFR Section record- per annual record- hours
keepers record- records keeping
keeper
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 the formulation or recipe, that a Dated: March 4, 2015.
use of health claims, we estimate that manufacturer has and maintains as a Leslie Kux,
only about 25 firms would be likely to normal course of its doing business.
mstockstill on DSK4VPTVN1PROD with NOTICES
Associate Commissioner for Policy.
market products bearing a soy protein/ Thus, the burden to the food [FR Doc. 2015–05504 Filed 3–9–15; 8:45 am]
coronary heart disease health claim and manufacturer is limited to assembling BILLING CODE 4164–01–P
that only, perhaps, one of each firm’s and retaining the records, which we
products might contain non-soy sources estimate will take 1 hour annually.
of protein along with soy protein. The
records required to be retained by
§ 101.82(c)(2)(ii)(B) are the records, e.g.,
VerDate Sep<11>2014 17:53 Mar 09, 2015 Jkt 235001 PO 00000 Frm 00025 Fmt 4703 Sfmt 9990 E:\FR\FM\10MRN1.SGM 10MRN1](https://thefederalregister.org/doc/80_FR_12686/page/2.svg)
Document Created: 2018-02-21 09:34:51
Document Modified: 2018-02-21 09:34:51
| 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 | Submit either electronic or written comments on the collection of information by May 11, 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 12640 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR