Document ID: FDA-2017-N-1064-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; State Petitions for
Exemption From Preemption
Posted Date: 2017-11-06T05:00Z

[Federal Register Volume 82, Number 213 (Monday, November 6, 2017)]
[Notices]
[Page 51421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24106]

[[Page 51421]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1064]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; State Petitions for 
Exemption From Preemption

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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 
December 6, 2017.

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 0910-0277. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[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.

State Petitions for Exemption From Preemption

OMB Control Number 0910-0277--Extension

    Under section 403A(b) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 343-1(b)), States may petition FDA for 
exemption from Federal preemption of State food labeling and standard-
of-identity requirements. Section 100.1(d) (21 CFR 100.1(d)) sets forth 
the information a State is required to submit in such a petition. The 
information required under Sec.  100.1(d) enables FDA to determine 
whether the State food labeling or standard-of-identity requirement 
satisfies the criteria of section 403A(b) of the FD&C Act for granting 
exemption from Federal preemption.
    In the Federal Register of June 15, 2017 (82 FR 27491), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received no comments.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                          21 CFR 100.1(d)                               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Form of petition...................................................               1                1                1               40               40
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The reporting burden for Sec.  100.1(d) is minimal because 
petitions for exemption from preemption are seldom submitted by States. 
In the last 3 years, we have received one new petition for exemption 
from preemption; therefore, we estimate that one or fewer petitions 
will be submitted annually.

    Dated: November 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24106 Filed 11-3-17; 8:45 am]
 BILLING CODE 4164-01-P