82 FR 51421 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 213 (November 6, 2017)

Page Range		51421-51421
FR Document		2017-24106

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.

Federal Register, Volume 82 Issue 213 (Monday, November 6, 2017)

[Federal Register Volume 82, Number 213 (Monday, November 6, 2017)]
[Notices]
[Page 51421]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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

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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                          21 CFR 100.1(d)                               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form of petition...................................................               1                1                1               40               40
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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

Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices 51421

DEPARTMENT OF HEALTH AND comments be faxed to the Office of State Petitions for Exemption From
HUMAN SERVICES Information and Regulatory Affairs, Preemption
OMB, Attn: FDA Desk Officer, Fax: 202– OMB Control Number 0910–0277—
Food and Drug Administration 395–7285, or emailed to oira_ Extension
[Docket No. FDA–2017–N–1064] submission@omb.eop.gov. All
comments should be identified with the Under section 403A(b) of the Federal
Agency Information Collection OMB control number 0910–0277. Also Food, Drug, and Cosmetic Act (the
Activities; Submission for Office of include the FDA docket number found FD&C Act) (21 U.S.C. 343–1(b)), States
Management and Budget Review; in brackets in the heading of this may petition FDA for exemption from
Comment Request; State Petitions for document. Federal preemption of State food
Exemption From Preemption labeling and standard-of-identity
FOR FURTHER INFORMATION CONTACT: Ila requirements. Section 100.1(d) (21 CFR
AGENCY: Food and Drug Administration, S. Mizrachi, Office of Operations, Food 100.1(d)) sets forth the information a
HHS. and Drug Administration, Three White State is required to submit in such a
ACTION: Notice. Flint North, 10A–12M, 11601 petition. The information required
Landsdown St., North Bethesda, MD under § 100.1(d) enables FDA to
SUMMARY: The Food and Drug determine whether the State food
Administration (FDA or we) is 20852, 301–796–7726, PRAStaff@
fda.hhs.gov. labeling or standard-of-identity
announcing that a proposed collection requirement satisfies the criteria of
of information has been submitted to the SUPPLEMENTARY INFORMATION: In section 403A(b) of the FD&C Act for
Office of Management and Budget granting exemption from Federal
compliance with 44 U.S.C. 3507, FDA
(OMB) for review and clearance under preemption.
has submitted the following proposed
the Paperwork Reduction Act of 1995. In the Federal Register of June 15,
collection of information to OMB for
DATES: Fax written comments on the 2017 (82 FR 27491), FDA published a
review and clearance.
collection of information by December 60-day notice requesting public
6, 2017. comment on the proposed collection of
ADDRESSES: To ensure that comments on information. We received no comments.
the information collection are received, FDA estimates the burden of this
OMB recommends that written collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR 100.1(d) responses per burden per Total hours
respondents responses
respondent response

Form of petition .................................................................... 1 1 1 40 40
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The reporting burden for § 100.1(d) is DEPARTMENT OF HEALTH AND amended by the FDA Reauthorization
minimal because petitions for HUMAN SERVICES Act of 2017, which resulted in changes
exemption from preemption are seldom to the pre-submission of facility
submitted by States. In the last 3 years, Food and Drug Administration information. Pre-submitting facility
we have received one new petition for information enables the Agency to
[Docket No. FDA–2017–D–3101] determine whether inspection of a
exemption from preemption; therefore,
we estimate that one or fewer petitions facility is necessary and, if so, to begin
Abbreviated New Drug Applications:
will be submitted annually. inspection planning in advance of an
Pre-Submission of Facility Information
abbreviated new drug application
Dated: November 1, 2017. Related to Prioritized Generic Drug
(ANDA) receipt.
Anna K. Abram, Applications (Pre-Submission Facility
Correspondence); Draft Guidance for DATES: Submit either electronic or
Deputy Commissioner for Policy, Planning, written comments on the draft guidance
Industry; Availability
Legislation, and Analysis. by February 5, 2018 to ensure that the
[FR Doc. 2017–24106 Filed 11–3–17; 8:45 am] AGENCY: Food and Drug Administration, Agency considers your comment on this
BILLING CODE 4164–01–P HHS. draft guidance before it begins work on
ACTION: Notice of availability. the final version of the guidance.
Submit either electronic or written
SUMMARY: The Food and Drug comments concerning the collection of
Administration (FDA or Agency) is information proposed in the draft
announcing the availability of a revised guidance by January 5, 2018.
draft guidance for industry entitled ADDRESSES: You may submit comments
Pmangrum on DSK3GDR082PROD with NOTICES

‘‘ANDAs: Pre-Submission of Facility on any guidance at any time as follows:
Information Related to Prioritized
Generic Drug Applications (Pre- Electronic Submissions
Submission Facility Correspondence).’’ Submit electronic comments in the
FDA is revising the draft guidance following way:
because, after issuance of the original • Federal eRulemaking Portal:
draft guidance, the Federal Food, Drug, https://www.regulations.gov. Follow the
and Cosmetic Act (the FD&C Act) was instructions for submitting comments.

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Document Created: 2017-11-07 10:30:54
Document Modified: 2017-11-07 10:30:54

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 December 6, 2017.
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]
FR Citation		82 FR 51421

82 FR 51421 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 213 (November 6, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration