Agency Information Collection Activities; Proposed Collection; Comment Request; Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body, 69494-69496 [2014-27517]

Download as PDF 69494 Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices Substances Prohibited From Use in Animal Food or Feed—21 CFR Part 589 (OMB Control Number 0910–0627— Revision) This regulation prohibits the use of certain cattle origin materials in the food or feed of all animals to help prevent the spread of bovine spongiform encephalopathy (BSE) in United States’ cattle. BSE is a progressive and fatal neurological disorder of cattle that results from an unconventional transmissible agent. BSE belongs to the family of diseases known as transmissible spongiform encephalopathies (TSEs). All TSEs affect the central nervous system of infected animals. These measures will further strengthen existing safeguards against BSE. Description of Recordkeeping for Respondents: Rendering facilities, medicated feed manufacturers, livestock feeders. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 21 CFR Section 589.2001; substances prohibited from use in animal food or feed Number of recordkeepers Number of records per recordkeeper Average burden per recordkeeper Total annual records Total hours Operating and maintenance costs 589.2001(c)(2)(vi) and (c)(3)(i) ................ 589.2001(c)(2)(ii) ...................................... 589.2001(c)(3)(i)(A) .................................. 175 50 175 1 1 1 175 50 175 20 20 26 3,500 1,000 4,550 $59,500 17,000 80,580 Total .................................................. ........................ ........................ ........................ ........................ 9,050 157,080 1 There are no capital costs associated with this collection of information. The number of recordkeepers times the number of records per recordkeeper equals total annual records. Total annual records times average burden per recordkeeper equals total hours. Description of Respondents for Reporting: The final regulation on BSE (73 FR 22720) included a provision that exempts cattle materials prohibited in animal feed (CMPAF) from designated countries from the prohibition on its use in animal feed. A foreign country seeking this designation will submit a written request to FDA that includes a variety of information about the country’s BSE status (§ 589.2001(f)). During the past 6 years, FDA received 2 requests from countries to be exempted from CMPAF restrictions. FDA estimates the reporting burden for this information collection as follows: TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1 One-time (initial) burden ...................................................... Burden from future review ................................................... 1 There Number of responses per respondent Number of respondents 21 CFR Section 589.2001(f) 1 1 1 1 1 1 Total hours 80 26 80 26 are no capital costs or operating costs associated with the collection of information. One-Time (initial) Reporting Burden There will be a one-time burden to countries that apply to FDA seeking to be designated as not subject to restrictions applicable to CMPAF. We estimate that each country that applies for an exclusion will spend 80 hours putting information together to submit to FDA. Table 2 row 1 presents the onetime burden for the exclusion. (See final BSE regulation at 73 FR 22754). undergoing a review in the future about one third the time and effort it did when the information was submitted. Table 2 row 2 presents the expected recurring burden. Dated: November 17, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–27518 Filed 11–20–14; 8:45 am] BILLING CODE 4164–01–P Recurring Burden mstockstill on DSK4VPTVN1PROD with NOTICES Average burden per respondent Total annual responses 18:00 Nov 20, 2014 Jkt 235001 PO 00000 Food and Drug Administration [Docket No. FDA–2011–N–0535] Agency Information Collection Activities; Proposed Collection; Comment Request; Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body AGENCY: Countries that successfully petition FDA to be designated as exempt from certain BSE-related restrictions applicable to animal feed will be subject to future review by FDA to ensure that their designation remains appropriate. As part of this process, FDA may ask designated countries from time to time to confirm that their BSE situation and the information submitted by them in support of their original application remains unchanged. We assume it will take FDA and the designated country VerDate Sep<11>2014 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our 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, SUMMARY: Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\21NON1.SGM 21NON1 69495 Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices including each proposed extension of an existing collection of information, and to allow 60 days for public comment. This notice invites comments on the collection of information associated with the submission of notifications of health claims or nutrient content claims based on authoritative statements of scientific bodies of the U.S. Government. Submit either electronic or written comments on the collection of information by January 20, 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, PRAStaff@ fda.hhs.gov. DATES: 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 SUPPLEMENTARY INFORMATION: 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. Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body—(OMB Control Number 0910– 0374)—Extension Section 403(r)(2)(G) and (r)(3)(C) of the Federal Food, Drug and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(r)(2)(G) and (r)(3)(C)), as amended by the FDA Modernization Act of 1997, provides that any person may market a food product whose label bears a nutrient content claim or a health claim that is based on an authoritative statement of a scientific body of the U.S. Government or the National Academy of Sciences (NAS). Under this section of the FD&C Act, a person that intends to use such a claim must submit a notification of its intention to use the claim 120 days before it begins marketing the product bearing the claim. In the Federal Register of June 11, 1998 (63 FR 32102), we announced the availability of a guidance entitled ‘‘Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body.’’ The guidance provides the Agency’s interpretation of terms central to the submission of a notification and the Agency’s views on the information that should be included in the notification. We believe that the guidance will enable persons to meet the criteria for notifications that are established in section 403(r)(2)(G) and (r)(3)(C) of the FD&C Act. In addition to the information specifically required by the FD&C Act to be in such notifications, the guidance states that the notifications should also contain information on analytical methodology for the nutrient that is the subject of a claim based on an authoritative statement. We intend to review the notifications we receive to ensure that they comply with the criteria established by the FD&C Act. We estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents Section of the FD&C Act Average burden per response Total annual responses Total hours 403(r)(2)(G) (nutrient content claims) .................................. 403(r)(2)(C) (health claims) ................................................. Guidance for Notifications .................................................... 1 1 2 1 1 1 1 1 2 250 450 1 250 450 2 Total .............................................................................. ........................ ........................ ........................ ........................ 702 mstockstill on DSK4VPTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. These estimates are based on our experience with health claims, nutrient content claims, and other similar notification procedures that fall under our jurisdiction. To avoid estimating the number of respondents as zero, we estimate that there will be one or fewer respondents annually for nutrient content claim and health claim notifications. We estimate that we will receive one nutrient content claim notification and one health claim VerDate Sep<11>2014 18:00 Nov 20, 2014 Jkt 235001 notification per year over the next 3 years. Section 403(r)(2)(G) and (r)(3)(C) of the FD&C Act requires that the notification include the exact words of the claim, a copy of the authoritative statement, a concise description of the basis upon which such person relied for determining that this is an authoritative statement as outlined in the FD&C Act, and a balanced representation of the scientific literature relating to the PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 relationship between a nutrient and a disease or health-related condition to which a health claim refers or to the nutrient level to which the nutrient content claim refers. This balanced representation of the scientific literature is expected to include a bibliography of the scientific literature on the topic of the claim and a brief, balanced account or analysis of how this literature either supports or fails to support the authoritative statement. E:\FR\FM\21NON1.SGM 21NON1 69496 Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 / Notices Since the claims are based on authoritative statements of a scientific body of the U.S. Government or NAS, we believe that the information that is required by the FD&C Act to be submitted with a notification will be readily available to a respondent. However, the respondent will have to collect and assemble that information. Based on communications with firms that have submitted notifications, we estimate that one respondent will take 250 hours to collect and assemble the information required by the statute for a nutrient content claim notification. Further, we estimate that one respondent will take 450 hours to collect and assemble the information required by the statute for a health claim notification. Under the guidance, notifications should also contain information on analytical methodology for the nutrient that is the subject of a claim based on an authoritative statement. The guidance applies to both nutrient content claim and health claim notifications. We have determined that this information should be readily available to a respondent and, thus, we estimate that it will take a respondent 1 hour to incorporate the information into each notification. We expect there will be two respondents for a total of 2 hours. Dated: November 17, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–27517 Filed 11–20–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 1999–D–3528 (Formerly Docket No. 1999D–5046)] Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Guidance for Industry’’ dated December 2014. The guidance document provides mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:00 Nov 20, 2014 Jkt 235001 manufacturers of licensed whole blood and blood components intended for transfusion or for further manufacture, including source plasma, with recommendations concerning submission of changes to an approved biologics license application (BLA). The guidance document also provides manufacturers of licensed whole blood and blood components recommendations in connection with the applicability and content of comparability protocols and labeling changes. The guidance applies to the manufacture and distribution of licensed products. The guidance announced in this notice finalizes the draft guidance of the same title dated June 2013 and supersedes the document of the same title dated July 2001 (July 2001 guidance). DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 240–402–7800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a document entitled ‘‘Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Guidance for Industry’’ dated December 2014. The guidance document provides manufacturers of licensed whole blood and blood components intended for transfusion or for further manufacture, PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 including source plasma, with recommendations concerning submission of changes to an approved BLA in accordance with the requirements under Title 21 of the Code of Federal Regulations 601.12 (21 CFR 601.12). The guidance document also provides manufacturers of licensed whole blood and blood components with recommendations in connection with the applicability and content of comparability protocols under § 601.12(e) and labeling changes under § 601.12(f). Frequently, a manufacturer of a licensed product determines that it is appropriate to make a change in its product, production process, quality controls, equipment, facilities, responsible personnel, or labeling as documented in its approved BLA(s). Section 601.12 states the requirements to report such changes for licensed biological products to FDA. The recommendations contained in the guidance document reflect current FDA and industry experience with reporting changes to an approved application, including reporting the implementation of new technologies. The recommendations have been revised for reporting categories for certain changes to an approved application that were in the July 2001 guidance based on the experience gained over the last decade. In the Federal Register of May 31, 2013 (78 FR 32668), FDA announced the availability of the draft guidance of the same title dated June 2013. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. In response to comments, the guidance includes the addition of numerous appendices with tables to highlight the appropriate reporting categories related to certain manufacturing changes. The guidance announced in this notice finalizes the draft guidance dated June 2013. The guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents FDA’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 The guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork E:\FR\FM\21NON1.SGM 21NON1

Agencies

[Federal Register Volume 79, Number 225 (Friday, November 21, 2014)]
[Notices]
[Pages 69494-69496]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27517]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0535]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Notification of a Health Claim or Nutrient Content 
Claim Based on an Authoritative Statement of a Scientific Body

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing an 
opportunity for public comment on our 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,

[[Page 69495]]

including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment. This notice 
invites comments on the collection of information associated with the 
submission of notifications of health claims or nutrient content claims 
based on authoritative statements of scientific bodies of the U.S. 
Government.

DATES: Submit either electronic or written comments on the collection 
of information by January 20, 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, PRAStaff@fda.hhs.gov.

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.

Notification of a Health Claim or Nutrient Content Claim Based on an 
Authoritative Statement of a Scientific Body--(OMB Control Number 0910-
0374)--Extension

    Section 403(r)(2)(G) and (r)(3)(C) of the Federal Food, Drug and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 343(r)(2)(G) and (r)(3)(C)), as 
amended by the FDA Modernization Act of 1997, provides that any person 
may market a food product whose label bears a nutrient content claim or 
a health claim that is based on an authoritative statement of a 
scientific body of the U.S. Government or the National Academy of 
Sciences (NAS). Under this section of the FD&C Act, a person that 
intends to use such a claim must submit a notification of its intention 
to use the claim 120 days before it begins marketing the product 
bearing the claim. In the Federal Register of June 11, 1998 (63 FR 
32102), we announced the availability of a guidance entitled ``Guidance 
for Industry: Notification of a Health Claim or Nutrient Content Claim 
Based on an Authoritative Statement of a Scientific Body.'' The 
guidance provides the Agency's interpretation of terms central to the 
submission of a notification and the Agency's views on the information 
that should be included in the notification. We believe that the 
guidance will enable persons to meet the criteria for notifications 
that are established in section 403(r)(2)(G) and (r)(3)(C) of the FD&C 
Act. In addition to the information specifically required by the FD&C 
Act to be in such notifications, the guidance states that the 
notifications should also contain information on analytical methodology 
for the nutrient that is the subject of a claim based on an 
authoritative statement. We intend to review the notifications we 
receive to ensure that they comply with the criteria established by the 
FD&C Act.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
     Section of the FD&C Act         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
403(r)(2)(G) (nutrient content                 1               1               1             250             250
 claims)........................
403(r)(2)(C) (health claims)....               1               1               1             450             450
Guidance for Notifications......               2               1               2               1               2
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             702
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    These estimates are based on our experience with health claims, 
nutrient content claims, and other similar notification procedures that 
fall under our jurisdiction. To avoid estimating the number of 
respondents as zero, we estimate that there will be one or fewer 
respondents annually for nutrient content claim and health claim 
notifications. We estimate that we will receive one nutrient content 
claim notification and one health claim notification per year over the 
next 3 years.
    Section 403(r)(2)(G) and (r)(3)(C) of the FD&C Act requires that 
the notification include the exact words of the claim, a copy of the 
authoritative statement, a concise description of the basis upon which 
such person relied for determining that this is an authoritative 
statement as outlined in the FD&C Act, and a balanced representation of 
the scientific literature relating to the relationship between a 
nutrient and a disease or health-related condition to which a health 
claim refers or to the nutrient level to which the nutrient content 
claim refers. This balanced representation of the scientific literature 
is expected to include a bibliography of the scientific literature on 
the topic of the claim and a brief, balanced account or analysis of how 
this literature either supports or fails to support the authoritative 
statement.

[[Page 69496]]

    Since the claims are based on authoritative statements of a 
scientific body of the U.S. Government or NAS, we believe that the 
information that is required by the FD&C Act to be submitted with a 
notification will be readily available to a respondent. However, the 
respondent will have to collect and assemble that information. Based on 
communications with firms that have submitted notifications, we 
estimate that one respondent will take 250 hours to collect and 
assemble the information required by the statute for a nutrient content 
claim notification. Further, we estimate that one respondent will take 
450 hours to collect and assemble the information required by the 
statute for a health claim notification.
    Under the guidance, notifications should also contain information 
on analytical methodology for the nutrient that is the subject of a 
claim based on an authoritative statement. The guidance applies to both 
nutrient content claim and health claim notifications. We have 
determined that this information should be readily available to a 
respondent and, thus, we estimate that it will take a respondent 1 hour 
to incorporate the information into each notification. We expect there 
will be two respondents for a total of 2 hours.

    Dated: November 17, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27517 Filed 11-20-14; 8:45 am]
BILLING CODE 4164-01-P