81 FR 1428 - Agency Information Collection Activities; Proposed Collection; 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 7 (January 12, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 7 (January 12, 2016)
| Page Range | 1428-1429 | |
| FR Document | 2016-00326 |
[Federal Register Volume 81, Number 7 (Tuesday, January 12, 2016)] [Notices] [Pages 1428-1429] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-00326] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0977] Agency Information Collection Activities; Proposed Collection; 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. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents. DATES: Submit either electronic or written comments on the collection of information by March 14, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2012-N-0977 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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 [[Page 1429]] comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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: 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. 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. Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents--21 CFR 1140 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 Sec. 897.24) and Sec. 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: ------------------------------------------------------------------------ ------------------------------------------------------------------------ 21 CFR 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. ------------------------------------------------------------------------ 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 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 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: January 6, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-00326 Filed 1-11-16; 8:45 am] BILLING CODE 4164-01-P
![1428 Federal Register / Vol. 81, No. 7 / Tuesday, January 12, 2016 / Notices
subsequent discussion paper (see DEPARTMENT OF HEALTH AND public submit the comment as a written/
SUPPLEMENTARY INFORMATION). FDA will HUMAN SERVICES paper submission and in the manner
do its best to accommodate requests to detailed (see ‘‘Written/Paper
make public comment. Individuals and Food and Drug Administration Submissions’’ and ‘‘Instructions’’).
organizations with common interests are [Docket No. FDA–2012–N–0977] Written/Paper Submissions
urged to consolidate or coordinate their
presentations, and request time for a Agency Information Collection Submit written/paper submissions as
joint presentation, or submit requests for Activities; Proposed Collection; follows:
• Mail/Hand delivery/Courier (for
designated representatives to participate Comment Request; Regulations
written/paper submissions): Division of
in the focused sessions. All requests to Restricting the Sale and Distribution of
Dockets Management (HFA–305), Food
make oral presentations must be Cigarettes and Smokeless Tobacco To
and Drug Administration, 5630 Fishers
received by February 2, 2016. FDA will Protect Children and Adolescents
Lane, Rm. 1061, Rockville, MD 20852.
determine the amount of time allotted to AGENCY: Food and Drug Administration, • For written/paper comments
each presenter and the approximate HHS. submitted to the Division of Dockets
time each oral presentation is to begin, Management, FDA will post your
ACTION: Notice.
and will select and notify participants comment, as well as any attachments,
by February 8, 2016. If selected for SUMMARY: The Food and Drug except for information submitted,
presentation, any presentation materials Administration (FDA) is announcing an marked, and identified, as confidential,
must be emailed to Jennifer Dickey (see opportunity for public comment on the if submitted as detailed in
FOR FURTHER INFORMATION CONTACT) no proposed collection of certain ‘‘Instructions.’’
later than February 16, 2016, at 4 p.m. information by the Agency. Under the Instructions: All submissions received
No commercial promotional material Paperwork Reduction Act of 1995 (the must include the Docket No. FDA–
will be permitted to be presented or PRA), Federal Agencies are required to 2012–N–0977 for ‘‘Agency Information
distributed at this public workshop. publish notice in the Federal Register Collection Activities; Proposed
concerning each proposed collection of Collection; Comment Request;
Transcripts: Please be advised that as Regulations Restricting the Sale and
soon as a transcript is available, it will information, including each proposed
extension of an existing collection of Distribution of Cigarettes and Smokeless
be accessible at http:// Tobacco to Protect Children and
www.regulations.gov. It may be viewed information, and to allow 60 days for
public comment in response to the Adolescents.’’ Received comments will
at the Division of Dockets Management be placed in the docket and, except for
(see ADDRESSES). A transcript will also notice. This notice solicits comments on
regulations restricting the sale and those submitted as ‘‘Confidential
be available in either hardcopy or on Submissions,’’ publicly viewable at
CD–ROM, after submission of a distribution of cigarettes and smokeless
tobacco to protect children and http://www.regulations.gov or at the
Freedom of Information request. The Division of Dockets Management
Freedom of Information Office address adolescents.
between 9 a.m. and 4 p.m., Monday
is available on the Agency’s Web site at DATES: Submit either electronic or through Friday.
http://www.fda.gov. A link to the written comments on the collection of • Confidential Submissions—To
transcripts will also be available information by March 14, 2016. submit a comment with confidential
approximately 45 days after the public ADDRESSES: You may submit comments information that you do not wish to be
workshop on the Internet at http:// as follows: made publicly available submit your
www.fda.gov/MedicalDevices/ comments only as a written/paper
Electronic Submissions submission. You should submit two
NewsEvents/WorkshopsConferences/
default.htm. (Select this public Submit electronic comments in the copies total. One copy will include the
workshop from the posted events list.) following way: information you claim to be confidential
• Federal eRulemaking Portal: http:// with a heading or cover note that states
III. Reference www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
The following reference is on display instructions for submitting comments. CONFIDENTIAL INFORMATION’’. The
in the Division of Dockets Management Comments submitted electronically, Agency will review this copy, including
(see ADDRESSES) and is available for including attachments, to http:// the claimed confidential information, in
www.regulations.gov will be posted to its consideration of comments. The
viewing by interested persons between
the docket unchanged. Because your second copy, which will have the
9 a.m. and 4 p.m., Monday through
comment will be made public, you are claimed confidential information
Friday; it is also available electronically
solely responsible for ensuring that your redacted/blacked out, will be available
at http://www.regulations.gov. FDA has
comment does not include any for public viewing and posted on http://
verified the Web site address, as of the
confidential information that you or a www.regulations.gov. Submit both
date this document publishes in the third party may not wish to be posted, copies to the Division of Dockets
Federal Register, but Web sites are such as medical information, your or Management. If you do not wish your
subject to change over time. anyone else’s Social Security number, or name and contact information to be
1. Please refer to FDA’s Web site on confidential business information, such made publicly available, you can
companion diagnostics, available at as a manufacturing process. Please note provide this information on the cover
http://www.fda.gov/ that if you include your name, contact sheet and not in the body of your
tkelley on DSK3SPTVN1PROD with NOTICES
companiondiagnostics. information, or other information that comments and you must identify this
Dated: January 5, 2016. identifies you in the body of your information as ‘‘confidential’’. Any
comments, that information will be information marked as ‘‘confidential’’
Leslie Kux,
posted on http://www.regulations.gov. will not be disclosed except in
Associate Commissioner for Policy. • If you want to submit a comment accordance with 21 CFR 10.20 and other
[FR Doc. 2016–00328 Filed 1–11–16; 8:45 am] with confidential information that you applicable disclosure law. For more
BILLING CODE 4164–01–P do not wish to be made available to the information about FDA’s posting of
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![Federal Register / Vol. 81, No. 7 / Tuesday, January 12, 2016 / Notices 1429
comments to public dockets, see 80 FR U.S.C. 3506(c)(2)(A)) requires Federal Regulations Restricting the Sale and
56469, September 18, 2015, or access Agencies to provide a 60-day notice in Distribution of Cigarettes and
the information at: http://www.fda.gov/ the Federal Register concerning each Smokeless Tobacco to Protect Children
regulatoryinformation/dockets/ proposed collection of information, and Adolescents—21 CFR 1140
default.htm. including each proposed extension of an OMB Control Number 0910–0312—
Docket: For access to the docket to existing collection of information, Extension
read background documents or the before submitting the collection to OMB
electronic and written/paper comments This is a request for an extension of
for approval. To comply with this
received, go to http:// OMB approval for the information
requirement, FDA is publishing notice
www.regulations.gov and insert the collection requirements contained in
of the proposed collection of FDA’s regulations for cigarettes and
docket number, found in brackets in the information set forth in this document.
heading of this document, into the smokeless tobacco containing nicotine.
‘‘Search’’ box and follow the prompts With respect to the following The regulations that are codified at 21
and/or go to the Division of Dockets collection of information, FDA invites CFR part 1140 are authorized by section
Management, 5630 Fishers Lane, Rm. comments on these topics: (1) Whether 102 of the Family Smoking Prevention
1061, Rockville, MD 20852. the proposed collection of information and Tobacco Control Act (Tobacco
is necessary for the proper performance Control Act) (Pub. L. 111–31). Section
FOR FURTHER INFORMATION CONTACT: FDA
of FDA’s functions, including whether 102 of the Tobacco Control Act required
PRA Staff, Office of Operations, Food FDA to publish a final rule regarding
and Drug Administration, 8455 the information will have practical
utility; (2) the accuracy of FDA’s cigarettes and smokeless tobacco
Colesville Rd., COLE–14526, Silver identical in its provisions to the
Spring, MD 20993–0002, PRAStaff@ estimate of the burden of the proposed
collection of information, including the regulation issued by FDA in 1996 (61 FR
fda.hhs.gov. 44396, August 28, 1996), with certain
validity of the methodology and
SUPPLEMENTARY INFORMATION: Under the assumptions used; (3) ways to enhance specified exceptions including that
PRA (44 U.S.C. 3501–3520), Federal the quality, utility, and clarity of the subpart C (which included § 897.24) and
Agencies must obtain approval from the information to be collected; and (4) § 897.32(c) be removed from the
Office of Management and Budget reissued rule (section 102(a)(2)(B)). The
ways to minimize the burden of the
(OMB) for each collection of reissued final rule was published in the
collection of information on
information they conduct or sponsor. Federal Register of March 19, 2010 (75
respondents, including through the use FR 13225).
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR of automated collection techniques, This collection includes reporting
1320.3(c) and includes Agency requests when appropriate, and other forms of information requirements for § 1140.30
or requirements that members of the information technology. which directs persons to notify FDA if
public submit reports, keep records, or they intend to use a form of advertising
provide information to a third party. that is not addressed in the regulations.
Section 3506(c)(2)(A) of the PRA (44 The requirements are as follows:
21 CFR 1140.30 .............................. Reporting ....................................... Directs persons to notify FDA if they intend to use a form of adver-
tising that is not originally described in the March 19, 2010, final
rule.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of re- Average bur-
Number of re- Total annual
21 CFR section sponses per den per re- Total hours
spondents responses
respondent sponse
1140.30 (Scope of Permissible Forms of Labeling and Ad-
vertising) ........................................................................... 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 regulations. The concept of permitted Dated: January 6, 2016.
collection of information were based on advertising in § 1140.30 is sufficiently Leslie Kux,
industry-prepared data and information broad to encompass most forms of Associate Commissioner for Policy.
regarding cigarette and smokeless advertising. FDA estimates that [FR Doc. 2016–00326 Filed 1–11–16; 8:45 am]
tobacco product advertising approximately 300 respondents will BILLING CODE 4164–01–P
expenditures. submit an annual notice of alternative
tkelley on DSK3SPTVN1PROD with NOTICES
Section 1140.30 requires advertising, and the Agency has
manufacturers, distributors, and estimated it should take 1 hour to
retailers: (1) To observe certain format provide such notice. Therefore, FDA
and content requirements for labeling estimates that the total time required for
and advertising, and (2) to notify FDA this collection of information is 300
if they intend to use an advertising hours.
medium that is not listed in the
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Document Created: 2016-01-12 01:23:13
Document Modified: 2016-01-12 01:23:13
| 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 March 14, 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 1428 |
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