81 FR 40319 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 119 (June 21, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 119 (June 21, 2016)
| Page Range | 40319-40320 | |
| FR Document | 2016-14628 |
[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)] [Notices] [Pages 40319-40320] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-14628] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0977] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- 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 July 21, 2016. 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 0910-0312. 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. [[Page 40320]] Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents OMB Control Number 0910-0312--Extension This is a request for an extension of OMB approval for the information collection requirements contained in FDA's regulations for cigarettes and smokeless tobacco containing nicotine. The regulations that are codified at 21 CFR part 1140 are authorized by section 102 of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31). Section 102 of the Tobacco Control Act required FDA to publish a final rule regarding cigarettes and smokeless tobacco identical in its provisions to the regulation issued by FDA in 1996 (61 FR 44396, August 28, 1996), with certain specified exceptions including that subpart C (which included 21 CFR 897.24) and 897.32(c) be removed from the reissued rule (section 102(a)(2)(B)). The reissued final rule was published in the Federal Register of March 19, 2010 (75 FR 13225). This collection includes reporting information requirements for Sec. 1140.30 which directs persons to notify FDA if they intend to use a form of advertising that is not addressed in the regulations. The requirements are as follows: ---------------------------------------------------------------------------------------------------------------- ---------------------------------------------------------------------------------------------------------------- Sec. 1140.30.......................... Reporting.................. Directs persons to notify FDA if they intend to use a form of advertising that is not originally described in the March 19, 2010, final rule. ---------------------------------------------------------------------------------------------------------------- In the Federal Register of January 12, 2016 (81 FR 1428), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR Section Number of responses per Total annual Average burden Total hours respondents respondent responses per response ----------------------------------------------------------------------------------------------------------------------------------------- 1140.30--Scope of Permissible Forms of Labeling and 300 1 300 1 300 Advertising........................................ -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The burden hour estimates for this collection of information were based on industry-prepared data and information regarding cigarette and smokeless tobacco product advertising expenditures. Section 1140.30 requires manufacturers, distributors, and retailers: (1) To observe certain format and content requirements for labeling and advertising and (2) to notify FDA if they intend to use an advertising medium that is not listed in the regulations. The concept of permitted advertising in Sec. 1140.30 is sufficiently broad to encompass most forms of advertising. FDA estimates that approximately 300 respondents will submit an annual notice of alternative advertising, and the Agency has estimated it should take 1 hour to provide such notice. Therefore, FDA estimates that the total time required for this collection of information is 300 hours. Dated: June 16, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-14628 Filed 6-20-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 119 / Tuesday, June 21, 2016 / Notices 40319
intended use claim, and enhance and data for pediatric uses of medical Register, but Web sites are subject to
encourage pediatric device development devices. It does not establish any rights change over time.
programs. for any person and is not binding on 1. FDA guidance entitled ‘‘Premarket
This guidance does not change the FDA or the public. You can use an Assessment of Pediatric Medical
regulatory threshold for valid scientific alternative approach if it satisfies the Devices,’’ March 24, 2014, available at
evidence. Instead, the document seeks requirements of the applicable statutes http://www.fda.gov/MedicalDevices/
to provide clarity and predictability for and regulations. DeviceRegulationandGuidance/
device sponsors and to ensure GuidanceDocuments/ucm089740.htm.
consistency within FDA regarding the III. Electronic Access
Dated: June 16, 2016.
specific criteria that should be Persons interested in obtaining a copy Leslie Kux,
considered when deciding whether of the guidance may do so by Associate Commissioner for Policy.
leveraging existing clinical data to downloading an electronic copy from [FR Doc. 2016–14640 Filed 6–20–16; 8:45 am]
support pediatric claims is appropriate, the Internet. A search capability for all
and if so, to what extent. When BILLING CODE 4164–01–P
Center for Devices and Radiological
considering extrapolation, sponsors are Health guidance documents is available
encouraged to engage FDA early in at http://www.fda.gov/MedicalDevices/
product development planning. DEPARTMENT OF HEALTH AND
DeviceRegulationandGuidance/ HUMAN SERVICES
For the purposes of this document, GuidanceDocuments/default.htm.
‘‘extrapolation’’ refers to the leveraging Guidance documents are also available Food and Drug Administration
process whereby an indication for use of at http://www.fda.gov/BiologicsBlood
a device in a new pediatric patient Vaccines/GuidanceCompliance
[Docket No. FDA–2012–N–0977]
population can be supported by existing RegulatoryInformation/default.htm or
clinical data from a studied patient Agency Information Collection
http://www.regulations.gov. Persons Activities; Submission for Office of
population. That is, when existing data unable to download an electronic copy
are relevant to a pediatric indication Management and Budget Review;
of ‘‘Leveraging Existing Clinical Data for Comment Request; Regulations
and determined to be valid scientific
Extrapolation to Pediatric Uses of Restricting the Sale and Distribution of
evidence, it may be scientifically
Medical Devices; Guidance for Industry Cigarettes and Smokeless Tobacco To
appropriate to attempt to extrapolate
and Food and Drug Administration Protect Children and Adolescents
such data to a pediatric use in support
Staff’’ may send an email request to
of demonstrating a reasonable assurance AGENCY: Food and Drug Administration,
CDRH-Guidance@fda.hhs.gov to receive
of effectiveness or probable benefit and, HHS.
an electronic copy of the document.
occasionally, safety.
FDA published in the Federal Please use the document number 1827 ACTION: Notice of availability.
Register of May 6, 2015 (80 FR 26061), to identify the guidance you are
requesting. SUMMARY: The Food and Drug
the document entitled ‘‘Leveraging Administration (FDA) is announcing
Existing Clinical Data for Extrapolation IV. Paperwork Reduction Act of 1995 that a proposed collection of
to Pediatric Uses of Medical Devices; information has been submitted to the
Guidance for Industry and Food and This guidance refers to previously
approved collections of information Office of Management and Budget
Drug Administration Staff’’ and the (OMB) for review and clearance under
comment period closed on August 4, found in FDA regulations. These
collections of information are subject to the Paperwork Reduction Act of 1995.
2015. FDA has considered all of the
review by the Office of Management and DATES: Fax written comments on the
comments received in finalizing this
guidance. The comments from the Budget (OMB) under the Paperwork collection of information by July 21,
docket sought further clarification of the Reduction Act of 1995 (44 U.S.C. 3501– 2016.
scope of the document, the extent of 3520). The collections of information in ADDRESSES: To ensure that comments on
extrapolation that may be feasible across 21 CFR parts 801 and 809 have been the information collection are received,
various pediatric subpopulations, and approved under OMB control number OMB recommends that written
the concept of ‘‘borrowing strength’’ 0910–0485 (medical device labeling); comments be faxed to the Office of
from existing adult data. Accordingly, the collections of information in 21 CFR Information and Regulatory Affairs,
this guidance document has been part 812 have been approved under OMB, Attn: FDA Desk Officer, FAX:
updated to include de novo requests OMB control number 0910–0078 202–395–7285, or emailed to oira_
within the scope and to provide (investigational device exemptions); the submission@omb.eop.gov. All
additional explanation on the concepts collections of information in 21 CFR comments should be identified with the
of extrapolation of data across pediatric part 814 have been approved under OMB control number 0910–0312. Also
subpopulations and ‘‘borrowing OMB control number 0910–0231 include the FDA docket number found
strength.’’ (subparts A through E, premarket in brackets in the heading of this
This guidance should be used in approval). document.
conjunction with other device-specific V. References FOR FURTHER INFORMATION CONTACT: FDA
guidances to help ensure that medical PRA Staff, Office of Operations, Food
devices intended for use in pediatric The following references are on
display in the Division of Dockets and Drug Administration, 8455
asabaliauskas on DSK3SPTVN1PROD with NOTICES
population provide reasonable Colesville Rd., COLE–14526, Silver
assurance of safety and effectiveness. Management (see ADDRESSES) and are
available for viewing by interested Spring, MD 20993–0002, PRAStaff@
II. Significance of Guidance persons between 9 a.m. and 4 p.m., fda.hhs.gov.
This guidance is being issued Monday through Friday; they are also SUPPLEMENTARY INFORMATION: In
consistent with FDA’s good guidance available electronically at http:// compliance with 44 U.S.C. 3507, FDA
practices regulation (21 CFR 10.115). www.regulations.gov. FDA has verified has submitted the following proposed
The guidance represents the current the Web site addresses, as of the date collection of information to OMB for
thinking of FDA on the extrapolation of this document publishes in the Federal review and clearance.
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![40320 Federal Register / Vol. 81, No. 119 / Tuesday, June 21, 2016 / Notices
Regulations Restricting the Sale and CFR part 1140 are authorized by section 897.24) and 897.32(c) be removed from
Distribution of Cigarettes and 102 of the Family Smoking Prevention the reissued rule (section 102(a)(2)(B)).
Smokeless Tobacco To Protect Children and Tobacco Control Act (Tobacco The reissued final rule was published in
and Adolescents OMB Control Number Control Act) (Pub. L. 111–31). Section the Federal Register of March 19, 2010
0910–0312—Extension 102 of the Tobacco Control Act required (75 FR 13225).
FDA to publish a final rule regarding
This is a request for an extension of This collection includes reporting
cigarettes and smokeless tobacco
OMB approval for the information identical in its provisions to the information requirements for § 1140.30
collection requirements contained in regulation issued by FDA in 1996 (61 FR which directs persons to notify FDA if
FDA’s regulations for cigarettes and 44396, August 28, 1996), with certain they intend to use a form of advertising
smokeless tobacco containing nicotine. specified exceptions including that that is not addressed in the regulations.
The regulations that are codified at 21 subpart C (which included 21 CFR The requirements are as follows:
§ 1140.30 ............................. Reporting ............................ Directs persons to notify FDA if they intend to use a form of advertising that is not
originally described in the March 19, 2010, final rule.
In the Federal Register of January 12, on the proposed collection of FDA estimates the burden of this
2016 (81 FR 1428), FDA published a 60- information. No comments were collection of information as follows:
day notice requesting public comment received.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR Section responses per burden per Total hours
respondents responses
respondent response
1140.30—Scope of Permissible Forms of Labeling and
Advertising ........................................................................ 300 1 300 1 300
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden hour estimates for this DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: To
collection of information were based on HUMAN SERVICES request more information on the
industry-prepared data and information proposed project or to obtain a copy of
regarding cigarette and smokeless Health Resources and Services the data collection plans and draft
tobacco product advertising Administration instruments, email paperwork@hrsa.gov
expenditures. or call the HRSA Information Collection
Agency Information Collection Clearance Officer at (301) 443–1984.
Section 1140.30 requires Activities: Proposed Collection: Public SUPPLEMENTARY INFORMATION: When
manufacturers, distributors, and Comment Request submitting comments or requesting
retailers: (1) To observe certain format
AGENCY:Health Resources and Services information, please include the
and content requirements for labeling
Administration, HHS. information request collection title for
and advertising and (2) to notify FDA if reference.
they intend to use an advertising ACTION: Notice. Information Collection Request Title:
medium that is not listed in the Children’s Hospitals Graduate Medical
regulations. The concept of permitted SUMMARY: In compliance with the Education Payment Program
advertising in § 1140.30 is sufficiently requirement for opportunity for public Application and Full-Time Equivalent
broad to encompass most forms of comment on proposed data collection Resident Assessment Forms OMB No.
advertising. FDA estimates that projects (section 3506(c)(2)(A) of the 0915–0247 Revision.
approximately 300 respondents will Paperwork Reduction Act of 1995), the Abstract: The Children’s Hospitals
submit an annual notice of alternative Health Resources and Services Graduate Medical Education (CHGME)
advertising, and the Agency has Administration (HRSA) announces Payment Program was enacted by Public
estimated it should take 1 hour to plans to submit an Information Law 106–129, and reauthorized by the
provide such notice. Therefore, FDA Collection Request (ICR), described CHGME Support Reauthorization Act of
estimates that the total time required for below, to the Office of Management and 2013 (Pub. L. 113–98) to provide
this collection of information is 300 Budget (OMB). Prior to submitting the Federal support for graduate medical
hours. ICR to OMB, HRSA seeks comments education (GME) to freestanding
from the public regarding the burden children’s hospitals. The legislation
Dated: June 16, 2016. indicates that eligible children’s
estimate, below, or any other aspect of
Leslie Kux, the ICR. hospitals will receive payments for both
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Associate Commissioner for Policy. direct and indirect medical education.
DATES: Comments on this ICR must be
[FR Doc. 2016–14628 Filed 6–20–16; 8:45 am] The CHGME Payment Program
received no later than August 22, 2016.
BILLING CODE 4164–01–P application and full-time equivalent
ADDRESSES: Submit your comments to (FTE) resident assessment forms
paperwork@hrsa.gov or mail the HRSA received OMB clearance on June 30,
Information Collection Clearance 2014.
Officer, Room 14N–39, 5600 Fishers The CHGME Support Reauthorization
Lane, Rockville, MD 20857. Act of 2013 included a provision to
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Document Created: 2016-06-21 01:30:37
Document Modified: 2016-06-21 01:30:37
| 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 of availability. | |
| Dates | Fax written comments on the collection of information by July 21, 2016. | |
| 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 | 81 FR 40319 |
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