80 FR 11443 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 41 (March 3, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 41 (March 3, 2015)
| Page Range | 11443-11444 | |
| FR Document | 2015-04380 |
[Federal Register Volume 80, Number 41 (Tuesday, March 3, 2015)] [Notices] [Pages 11443-11444] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-04380] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0535] Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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) 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 April 2, 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 0910-0374. 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. 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 [[Page 11444]] 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. In the Federal Register of November 21, 2014 (79 FR 69494), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received in response to the notice. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Section of the FD&C Act Number of responses per Total annual Average burden Total hours respondents respondent responses per 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. 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: February 24, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-04380 Filed 3-2-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 11443
expenditures in greater detail to of the costs for assistance provided to Medical Assistance. This proposed
anticipate any funding issues and to entering refugees. The estimating single-page financial report allows ORR
meet the requirements of ORR methodology prescribed in the to collect the necessary data to ensure
regulations at CFR 400.211 to collect regulations requires the use of actual that funds are adequate for the projected
these data for use in estimating future past costs by program component. In the need and thereby meet the requirements
costs of the refugee resettlement event that the methodology indicates of both the Refugee Act and ORR
program. ORR must implement the that appropriated funds are inadequate, regulations.
methodology at CFR 400.211 each year ORR must take steps to reduce federal
after receipt of its annual appropriation expenses, such as by limiting the Respondents: State governments,
to ensure that appropriated funds will number of months of eligibility for Wilson/Fish Alternative Projects.
be adequate for reimbursement to States Refugee Cash Assistance and Refugee
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
ORR Financial Status Report .......................................................................... 58 4 0.50 116
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: In
Hours: 116. HUMAN SERVICES compliance with 44 U.S.C. 3507, FDA
In compliance with the requirements has submitted the following proposed
Food and Drug Administration collection of information to OMB for
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the review and clearance.
[Docket No. FDA–2011–N–0535]
Administration for Children and Notification of a Health Claim or
Families is soliciting public comment Agency Information Collection Nutrient Content Claim Based on an
on the specific aspects of the Activities; Submission for Office of Authoritative Statement of a Scientific
information collection described above. Management and Budget Review; Body—(OMB Control Number 0910–
Copies of the proposed collection of Comment Request; Notification of a 0374)—Extension
information can be obtained and Health Claim or Nutrient Content Claim
Section 403(r)(2)(G) and (r)(3)(C) of
comments may be forwarded by writing Based on an Authoritative Statement
the Federal Food, Drug and Cosmetic
to the Administration for Children and of a Scientific Body
Act (the FD&C Act) (21 U.S.C.
Families, Office of Planning, Research AGENCY: Food and Drug Administration, 343(r)(2)(G) and (r)(3)(C)), as amended
and Evaluation, 370 L’Enfant HHS. by the FDA Modernization Act of 1997,
Promenade SW., Washington, DC 20447, ACTION: Notice. provides that any person may market a
Attn: ACF Reports Clearance Officer. food product whose label bears a
Email address: infocollection@ SUMMARY: The Food and Drug nutrient content claim or a health claim
acf.hhs.gov. All requests should be Administration (FDA) is announcing that is based on an authoritative
identified by the title of the information that a proposed collection of statement of a scientific body of the U.S.
collection. information has been submitted to the Government or the National Academy of
The Department specifically requests Office of Management and Budget Sciences (NAS). Under this section of
(OMB) for review and clearance under the FD&C Act, a person that intends to
comments on: (a) Whether the proposed
the Paperwork Reduction Act of 1995. use such a claim must submit a
collection of information is necessary
DATES: Fax written comments on the notification of its intention to use the
for the proper performance of the claim 120 days before it begins
functions of the agency, including collection of information by April 2,
2015. marketing the product bearing the
whether the information shall have claim. In the Federal Register of June
practical utility; (b) the accuracy of the ADDRESSES: To ensure that comments on 11, 1998 (63 FR 32102), we announced
agency’s estimate of the burden of the the information collection are received, the availability of a guidance entitled
proposed collection of information; (c) OMB recommends that written ‘‘Guidance for Industry: Notification of
the quality, utility, and clarity of the comments be faxed to the Office of a Health Claim or Nutrient Content
information to be collected; and (d) Information and Regulatory Affairs, Claim Based on an Authoritative
ways to minimize the burden of the OMB, Attn: FDA Desk Officer, FAX: Statement of a Scientific Body.’’ The
collection of information on 202–395–7285, or emailed to oira_ guidance provides the Agency’s
respondents, including through the use submission@omb.eop.gov. All interpretation of terms central to the
of automated collection techniques or comments should be identified with the submission of a notification and the
other forms of information technology. OMB control number 0910–0374. Also Agency’s views on the information that
include the FDA docket number found should be included in the notification.
Consideration will be given to
in brackets in the heading of this
mstockstill on DSK4VPTVN1PROD with NOTICES
comments and suggestions submitted We believe that the guidance will enable
document. persons to meet the criteria for
within 60 days of this publication.
FOR FURTHER INFORMATION CONTACT: FDA notifications that are established in
Robert Sargis, PRA Staff, Office of Operations, Food section 403(r)(2)(G) and (r)(3)(C) of the
Reports Clearance Officer. and Drug Administration, 8455 FD&C Act. In addition to the
[FR Doc. 2015–04365 Filed 3–2–15; 8:45 am] Colesville Rd., COLE–14526, Silver information specifically required by the
BILLING CODE 4184–01–P Spring, MD 20993–0002 PRAStaff@ FD&C Act to be in such notifications,
fda.hhs.gov. the guidance states that the notifications
VerDate Sep<11>2014 19:24 Mar 02, 2015 Jkt 235001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\03MRN1.SGM 03MRN1](https://thefederalregister.org/doc/80_FR_11484/page/1.svg)
![11444 Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices
should also contain information on ensure that they comply with the comment on the proposed collection of
analytical methodology for the nutrient criteria established by the FD&C Act. information. No comments were
that is the subject of a claim based on In the Federal Register of November received in response to the notice.
an authoritative statement. We intend to 21, 2014 (79 FR 69494), FDA published FDA estimates the burden of this
review the notifications we receive to a 60-day notice requesting public collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Section of the FD&C Act responses per burden per Total hours
respondents responses
respondent response
403(r)(2)(G) (nutrient content claims) .................................. 1 1 1 250 250
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 a nutrient content claim notification. that a proposed collection of
experience with health claims, nutrient Further, we estimate that one information has been submitted to the
content claims, and other similar respondent will take 450 hours to Office of Management and Budget
notification procedures that fall under collect and assemble the information (OMB) for review and clearance under
our jurisdiction. To avoid estimating the required by the statute for a health claim the Paperwork Reduction Act of 1995.
number of respondents as zero, we notification. DATES: Fax written comments on the
estimate that there will be one or fewer Under the guidance, notifications collection of information by April 2,
respondents annually for nutrient should also contain information on 2015.
content claim and health claim analytical methodology for the nutrient
notifications. We estimate that we will that is the subject of a claim based on ADDRESSES: To ensure that comments on
receive one nutrient content claim an authoritative statement. The the information collection are received,
notification and one health claim guidance applies to both nutrient OMB recommends that written
notification per year over the next 3 content claim and health claim comments be faxed to the Office of
years. notifications. We have determined that Information and Regulatory Affairs,
Section 403(r)(2)(G) and (r)(3)(C) of this information should be readily OMB, Attn: FDA Desk Officer, FAX:
the FD&C Act requires that the available to a respondent and, thus, we 202–395–7285, or emailed to oira_
notification include the exact words of estimate that it will take a respondent 1 submission@omb.eop.gov. All
the claim, a copy of the authoritative hour to incorporate the information into comments should be identified with the
statement, a concise description of the each notification. We expect there will OMB control number 0910–0116. Also
basis upon which such person relied for be two respondents for a total of 2 include the FDA docket number found
determining that this is an authoritative hours. in brackets in the heading of this
statement as outlined in the FD&C Act, Dated: February 24, 2015. document.
and a balanced representation of the Leslie Kux, FOR FURTHER INFORMATION CONTACT: FDA
scientific literature relating to the PRA Staff, Office of Operations, Food
Associate Commissioner for Policy.
relationship between a nutrient and a and Drug Administration, 8455
[FR Doc. 2015–04380 Filed 3–2–15; 8:45 am]
disease or health-related condition to Colesville Rd., COLE–14526, Silver
BILLING CODE 4164–01–P
which a health claim refers or to the Spring, MD 20993–0002, PRAStaff@
nutrient level to which the nutrient fda.hhs.gov.
content claim refers. This balanced
DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: In
representation of the scientific literature
HUMAN SERVICES compliance with 44 U.S.C. 3507, FDA
is expected to include a bibliography of
the scientific literature on the topic of Food and Drug Administration has submitted the following proposed
the claim and a brief, balanced account collection of information to OMB for
or analysis of how this literature either [Docket No. FDA–2005–N–0161] review and clearance.
supports or fails to support the Current Good Manufacturing Practices
authoritative statement. Agency Information Collection
Activities; Submission for Office of and Related Regulations for Blood and
Since the claims are based on
Management and Budget Review; Blood Components; and Requirements
authoritative statements of a scientific
Comment Request; Current Good for Donor Testing, Donor Notification,
body of the U.S. Government or NAS,
Manufacturing Practices and Related and ‘‘Lookback’’—(OMB Control
we believe that the information that is
Regulations for Blood and Blood Number 0910–0116)—Extension
required by the FD&C Act to be
submitted with a notification will be Components; and Requirements for All blood and blood components
Donor Testing, Donor Notification, and
mstockstill on DSK4VPTVN1PROD with NOTICES
readily available to a respondent. introduced or delivered for introduction
However, the respondent will have to ‘‘Lookback’’ into interstate commerce are subject to
collect and assemble that information. AGENCY: Food and Drug Administration, section 351(a) of the Public Health
Based on communications with firms HHS. Service Act (PHS Act) (42 U.S.C.
that have submitted notifications, we ACTION: Notice. 262(a)). Section 351(a) requires that
estimate that one respondent will take manufacturers of biological products,
250 hours to collect and assemble the SUMMARY: The Food and Drug which include blood and blood
information required by the statute for Administration (FDA) is announcing components intended for further
VerDate Sep<11>2014 19:24 Mar 02, 2015 Jkt 235001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\03MRN1.SGM 03MRN1](https://thefederalregister.org/doc/80_FR_11484/page/2.svg)
Document Created: 2015-12-18 11:55:18
Document Modified: 2015-12-18 11:55:18
| 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 April 2, 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 11443 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR