82 FR 27491 - Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 114 (June 15, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 114 (June 15, 2017)
| Page Range | 27491-27492 | |
| FR Document | 2017-12445 |
[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)] [Notices] [Pages 27491-27492] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12445] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-1064] Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 solicits comments on the information collection provisions of our reporting requirements contained in existing FDA regulations governing State petitions for exemption from preemption. DATES: Submit either electronic or written comments on the collection of information by August 14, 2017. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 14, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 14, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov/. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov/ will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov/. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2017-N-1064 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov/ or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov/. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov/ and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 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, FDA is publishing notice of the proposed collection of information set forth in this document. [[Page 27492]] With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's 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. State Petitions for Exemption From Preemption--21 CFR 100.1(d) 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. 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: June 12, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-12445 Filed 6-14-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices 27491
take a respondent 2 hours per request to the instructions for submitting Agency will review this copy, including
comply with the requirements of that comments. Comments submitted the claimed confidential information, in
section, for a total of 4 hours. electronically, including attachments, to its consideration of comments. The
Dated: June 12, 2017. https://www.regulations.gov/ will be second copy, which will have the
Anna K. Abram, posted to the docket unchanged. claimed confidential information
Because your comment will be made redacted/blacked out, will be available
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis. public, you are solely responsible for for public viewing and posted on
ensuring that your comment does not https://www.regulations.gov/. Submit
[FR Doc. 2017–12438 Filed 6–14–17; 8:45 am]
include any confidential information both copies to the Dockets Management
BILLING CODE 4164–01–P
that you or a third party may not wish Staff. If you do not wish your name and
to be posted, such as medical contact information to be made publicly
DEPARTMENT OF HEALTH AND information, your or anyone else’s available, you can provide this
HUMAN SERVICES Social Security number, or confidential information on the cover sheet and not
business information, such as a in the body of your comments and you
Food and Drug Administration manufacturing process. Please note that must identify this information as
if you include your name, contact ‘‘confidential.’’ Any information marked
[Docket No. FDA–2017–N–1064] information, or other information that as ‘‘confidential’’ will not be disclosed
identifies you in the body of your except in accordance with 21 CFR 10.20
Agency Information Collection
comments, that information will be and other applicable disclosure law. For
Activities; Proposed Collection;
posted on https://www.regulations.gov/. more information about FDA’s posting
Comment Request; State Petitions for
• If you want to submit a comment of comments to public dockets, see 80
Exemption From Preemption
with confidential information that you FR 56469, September 18, 2015, or access
AGENCY: Food and Drug Administration, do not wish to be made available to the the information at: https://www.gpo.gov/
HHS. public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
ACTION: Notice. written/paper submission and in the 23389.pdf.
manner detailed (see ‘‘Written/Paper
SUMMARY: The Food and Drug Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’).
Administration (FDA or Agency) is read background documents or the
announcing an opportunity for public Written/Paper Submissions electronic and written/paper comments
comment on the proposed collection of Submit written/paper submissions as received, go to https://
certain information by the Agency. follows: www.regulations.gov/ and insert the
Under the Paperwork Reduction Act of • Mail/Hand delivery/Courier (for docket number, found in brackets in the
1995 (PRA), Federal Agencies are written/paper submissions): Dockets heading of this document, into the
required to publish notice in the Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts
Federal Register concerning each Drug Administration, 5630 Fishers and/or go to the Dockets Management
proposed collection of information, Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061,
including each proposed extension of an • For written/paper comments Rockville, MD 20852.
existing collection of information, and submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT:
to allow 60 days for public comment in Staff, FDA will post your comment, as JonnaLynn Capezzuto, Office of
response to the notice. This notice well as any attachments, except for Operations, Food and Drug
solicits comments on the information information submitted, marked and Administration, Three White Flint
collection provisions of our reporting identified, as confidential, if submitted North, 10A63, 11601 Landsdown St.,
requirements contained in existing FDA as detailed in ‘‘Instructions.’’ North Bethesda, MD 20852, 301–796–
regulations governing State petitions for Instructions: All submissions received
3794, PRAStaff@fda.hhs.gov.
exemption from preemption. must include the Docket No. FDA–
DATES: Submit either electronic or 2017–N–1064 for ‘‘Agency Information SUPPLEMENTARY INFORMATION: Under the
written comments on the collection of Collection Activities; Proposed PRA (44 U.S.C. 3501–3520), Federal
information by August 14, 2017. Collection; Comment Request; State Agencies must obtain approval from the
ADDRESSES: You may submit comments Petitions for Exemption From Office of Management and Budget
as follows. Please note that late, Preemption.’’ Received comments, those (OMB) for each collection of
untimely filed comments will not be filed in a timely manner (see information they conduct or sponsor.
considered. Electronic comments must ADDRESSES), will be placed in the docket ‘‘Collection of information’’ is defined
be submitted on or before August 14, and, except for those submitted as in 44 U.S.C. 3502(3) and 5 CFR
2017. The https://www.regulations.gov ‘‘Confidential Submissions,’’ publicly 1320.3(c) and includes Agency requests
electronic filing system will accept viewable at https:// or requirements that members of the
comments until midnight Eastern Time www.regulations.gov/ or at the Dockets public submit reports, keep records, or
at the end of August 14, 2017. Management Staff between 9 a.m. and 4 provide information to a third party.
Comments received by mail/hand p.m., Monday through Friday. Section 3506(c)(2)(A) of the PRA (44
delivery/courier (for written/paper • Confidential Submissions—To U.S.C. 3506(c)(2)(A)) requires Federal
submissions) will be considered timely submit a comment with confidential Agencies to provide a 60-day notice in
if they are postmarked or the delivery information that you do not wish to be the Federal Register concerning each
pmangrum on DSK3GDR082PROD with NOTICES
service acceptance receipt is on or made publicly available, submit your proposed collection of information,
before that date. comments only as a written/paper including each proposed extension of an
submission. You should submit two existing collection of information,
Electronic Submissions copies total. One copy will include the before submitting the collection to OMB
Submit electronic comments in the information you claim to be confidential for approval. To comply with this
following way: with a heading or cover note that states requirement, FDA is publishing notice
• Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS of the proposed collection of
https://www.regulations.gov/. Follow CONFIDENTIAL INFORMATION.’’ The information set forth in this document.
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![27492 Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
With respect to the following collection of information on Federal preemption of State food
collection of information, FDA invites respondents, including through the use labeling and standard-of-identity
comments on these topics: (1) Whether of automated collection techniques, requirements. Section 100.1(d) (21 CFR
the proposed collection of information when appropriate, and other forms of 100.1(d)) sets forth the information a
is necessary for the proper performance information technology. State is required to submit in such a
of FDA’s functions, including whether petition. The information required
the information will have practical State Petitions for Exemption From under § 100.1(d) enables FDA to
utility; (2) the accuracy of FDA’s Preemption—21 CFR 100.1(d) determine whether the State food
estimate of the burden of the proposed OMB Control Number 0910–0277— labeling or standard-of-identity
collection of information, including the Extension requirement satisfies the criteria of
validity of the methodology and section 403A(b) of the FD&C Act for
assumptions used; (3) ways to enhance Under section 403A(b) of the Federal granting exemption from Federal
the quality, utility, and clarity of the Food, Drug, and Cosmetic Act (the preemption.
information to be collected; and (4) FD&C Act) (21 U.S.C. 343–1(b)), States FDA estimates the burden of this
ways to minimize the burden of the may petition FDA for exemption from collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual Total
21 CFR 100.1(d) responses per burden per
respondents responses hours
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 DATES: Fax written comments on the employed to achieve these goals include
minimal because petitions for collection of information by July 17, individual indepth interviews, general
exemption from preemption are seldom 2017. public focus group interviews, intercept
submitted by States. In the last 3 years, ADDRESSES: To ensure that comments on interviews, self-administered surveys,
we have received one new petition for the information collection are received, gatekeeper surveys, and focus group
exemption from preemption; therefore, OMB recommends that written interviews. The methods to be used
we estimate that one or fewer petitions comments be faxed to the Office of serve the narrowly defined need for
will be submitted annually. Information and Regulatory Affairs, direct and informal opinion on a
Dated: June 12, 2017. OMB, Attn: FDA Desk Officer, FAX: specific topic and as a qualitative and
202–395–7285, or emailed to oira_ quantitative research tool, and have two
Anna K. Abram,
submission@omb.eop.gov. All major purposes:
Deputy Commissioner for Policy, Planning, (1) To obtain information that is
Legislation, and Analysis. comments should be identified with the
OMB control number 0910—NEW and useful for developing variables and
[FR Doc. 2017–12445 Filed 6–14–17; 8:45 am]
‘‘Data to Support Social and Behavioral measures for formulating the basic
BILLING CODE 4164–01–P objectives of social and behavioral
Research as Used by the Food and Drug
Administration.’’ Also include the FDA research; and
docket number found in brackets in the (2) To assess the potential
DEPARTMENT OF HEALTH AND effectiveness of FDA communications,
HUMAN SERVICES heading of this document.
behavioral interventions, and other
FOR FURTHER INFORMATION CONTACT: materials in reaching and successfully
Food and Drug Administration Domini Bean, Office of Operations, communicating and addressing
Food and Drug Administration, Three behavioral change with their intended
[Docket No. FDA–2016–N–2683] White Flint North, 10A63, 11601 audiences.
Landsdown St., North Bethesda, MD FDA will use these methods to test
Agency Information Collection 20852, 301–796–5733, PRAStaff@ and refine its ideas and to help develop
Activities; Submission for Office of fda.hhs.gov. communication and behavioral
Management and Budget Review;
SUPPLEMENTARY INFORMATION: In strategies research, but will generally
Comment Request; Data To Support
compliance with 44 U.S.C. 3507, FDA conduct further research before making
Social and Behavioral Research as
has submitted the following proposed important decisions such as adopting
Used by the Food and Drug
collection of information to OMB for new policies and allocating or
Administration
review and clearance. redirecting significant resources to
AGENCY: Food and Drug Administration, support these policies.
Data To Support Social and Behavioral FDA’s Center for Drug Evaluation and
HHS. Research as Used by the Food and Drug Research, Center for Biologics
ACTION: Notice. Administration—OMB Control Number Evaluation and Research, Office of the
0910—NEW
pmangrum on DSK3GDR082PROD with NOTICES
Commissioner, and potentially other
SUMMARY: The Food and Drug Understanding patients, consumers, Agency components will use this
Administration (FDA) is announcing and health care professionals’ mechanism to test communications and
that a proposed collection of perceptions and behaviors plays an social and behavioral methods about
information has been submitted to the important role in improving FDA’s regulated drug products on a variety of
Office of Management and Budget regulatory decisionmaking processes subjects related to consumer, patient, or
(OMB) for review and clearance under and communications impacting various health care professional perceptions,
the Paperwork Reduction Act of 1995. stakeholders. The methods to be beliefs, attitudes, behaviors, and use of
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Document Created: 2017-06-15 01:03:28
Document Modified: 2017-06-15 01:03:28
| 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 August 14, 2017. | |
| Contact | JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [email protected] | |
| FR Citation | 82 FR 27491 |
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