Modifications to Compliance Policy for Certain Deemed Tobacco Products; Extension of Comment Period, 14120-14121 [2019-06952]

Download as PDF 14120 Federal Register / Vol. 84, No. 68 / Tuesday, April 9, 2019 / Notices Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405, telephone 202–501–4755. Please cite OMB Control No. 3090–0274, Artin-Architecture Program National Artist Registry, GSA Form 7437, in all correspondence. Dated: April 1, 2019. David A. Shive, Chief Information Officer. [FR Doc. 2019–06914 Filed 4–8–19; 8:45 am] BILLING CODE 6820–34–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request amozie on DSK9F9SC42PROD with NOTICES Title: Disaster Information Collection Form. OMB No.: 0970–0476. Description: This is a request by the Administration for Children and Families (ACF) for an extension to a generic clearance for the Disaster Information Collection Form. A generic clearance is necessary because each of the thirteen program offices within ACF has a slightly different need for information about program impact information collection during a disaster. ACF oversees more than 60 programs that affect the normal day to day operations of families, children, individuals and communities in the United States. Many of these programs encourage grantees or state administrators to develop emergency preparedness plans, but do not have statutory authority to require these plans be in place. ACF facilitates the inclusion of emergency preparedness planning and training efforts for ACF programs. Presidential Policy Directive-8 (PPD– 8) provides federal guidance and planning procedures under established phases—protection, preparedness, response, recovery, and mitigation. The Disaster Information Collection Forms addressed in this clearance process provide assessment of ACF programs in disaster response, and recovery. ACF/Office of Human Services Emergency Preparedness and Response (OHSEPR) has a requirement under PPD–8, the National Response Framework, and the National Disaster Recovery Framework to report disaster impacts to ACF-supported human services programs to the HHS Secretary’s Operation Center (SOC) and interagency partners. ACF/OHSEPR works in partnership with the Assistant Secretary for Preparedness and Response (ASPR), and the Federal Emergency Management Agency (FEMA) to report assessments of disaster impacted ACF programs and the status of continuity of services and recovery. Respondents: State administrators, and/or ACF grantees. Annual Burden Estimates: The burden estimate is for approximately 10 state administrators, or grantees to go through all of the applicable questions on each individual form with the Regional and Central Office staff. Some ACF programs may have more questions and may have more respondents. Total burden is based on the number of submissions during the first three years of approval. Instrument Number of respondents Number of responses per respondent Burden hours per response Total burden hours Disaster Information Collection Form .............................................................. 50 1 1.5 75 An estimate of the number of disasters that would warrant data collection is difficult to calculate due to the unpredictable nature of disasters. For example, in 2012, there were 95 disasters nationwide but OHSEPR did not collect data on all of them because they had minimal effects on ACF programs. Additional Information: Copies of the proposed collection may be obtained by emailing infocollection@acf.hhs.gov. Alternatively, copies can also be obtained by writing to the Administration for Children and Families, Office of Planning, Research, and Evaluation, 330 C Street SW, Washington, DC 20201, Attn: ACF Reports Clearance Officer. All requests, emailed or written, should be identified by the title of the information collection. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should VerDate Sep<11>2014 18:15 Apr 08, 2019 Jkt 247001 be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Food and Drug Administration ‘‘Modifications to Compliance Policy for Certain Deemed Tobacco Products’’ that appeared in the Federal Register of March 14, 2019. In the draft guidance for industry, FDA requested comments on changes to the compliance policies for premarket review requirements for certain deemed tobacco products and how FDA intends to prioritize its enforcement resources with regard to the marketing of certain deemed tobacco products that do not have premarket authorization. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. [Docket No. FDA–2019–D–0661] DATES: Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2019–06945 Filed 4–8–19; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Modifications to Compliance Policy for Certain Deemed Tobacco Products; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Notice of availability; extension of comment period. ACTION: The Food and Drug Administration (FDA or the Agency) is extending the comment period for the draft guidance for industry entitled SUMMARY: PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 FDA is extending the comment period on the draft guidance for industry published March 14, 2019 (84 FR 9345). Submit either electronic or written comments by April 30, 2019, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. You must submit your comment(s) on or before April 30, 2019, to ensure that the Agency considers your comment(s) before it begins work on the final version of the guidance. ADDRESSES: E:\FR\FM\09APN1.SGM 09APN1 Federal Register / Vol. 84, No. 68 / Tuesday, April 9, 2019 / Notices 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’’). amozie on DSK9F9SC42PROD with NOTICES 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– 2019–D–0661 for ‘‘Modifications to Compliance Policy for Certain Deemed Tobacco Products.’’ Received comments 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 VerDate Sep<11>2014 18:15 Apr 08, 2019 Jkt 247001 ‘‘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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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: Gerie Voss, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993–0002, 1–877–287–1373, email: CTPRegulations@fda.hhs.gov. In the Federal Register of March 14, 2019, FDA published a draft guidance for industry with a 30-day comment period to request comments on changes to the compliance policies for premarket review requirements and how FDA plans to prioritize its enforcement resources with regard to certain deemed tobacco products in the United States that do not have the required FDA premarket authorization for marketing. Comments on the draft guidance for industry will inform how FDA intends to finalize the guidance. The Agency has received requests for an extension of the comment period for the draft guidance for industry. The requests conveyed concern that the current 30-day comment period does not allow sufficient time to develop a SUPPLEMENTARY INFORMATION: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 14121 response to the draft guidance for industry. FDA has considered the requests and is extending the comment period for the draft guidance for industry for 15 days, until April 30, 2019. The Agency believes that a 15-day extension allows adequate time for interested persons to submit comments without significantly delaying the process to finalize this guidance. Dated: April 3, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–06952 Filed 4–8–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA–MH– 19–425: Revision Application for Implementation Research to Inform and Enhance PEPFAR HIV Pre-exposure Prophylaxis. Date: April 29, 2019. Time: 12:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Jose H. Guerrier, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892, 301–435– 1137, guerriej@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA–MH– 19–425: Revision Application for Implementation Research to Inform and Enhance PEPFAR HIV Pre-exposure Prophylaxis. Date: April 29, 2019. Time: 12:00 p.m. to 4:00 p.m. E:\FR\FM\09APN1.SGM 09APN1

Agencies

[Federal Register Volume 84, Number 68 (Tuesday, April 9, 2019)]
[Notices]
[Pages 14120-14121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06952]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0661]


Modifications to Compliance Policy for Certain Deemed Tobacco 
Products; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the draft guidance for industry 
entitled ``Modifications to Compliance Policy for Certain Deemed 
Tobacco Products'' that appeared in the Federal Register of March 14, 
2019. In the draft guidance for industry, FDA requested comments on 
changes to the compliance policies for premarket review requirements 
for certain deemed tobacco products and how FDA intends to prioritize 
its enforcement resources with regard to the marketing of certain 
deemed tobacco products that do not have premarket authorization. The 
Agency is taking this action in response to requests for an extension 
to allow interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the draft guidance for 
industry published March 14, 2019 (84 FR 9345). Submit either 
electronic or written comments by April 30, 2019, to ensure that the 
Agency considers your comment on this draft guidance before it begins 
work on the final version of the guidance.

ADDRESSES: You must submit your comment(s) on or before April 30, 2019, 
to ensure that the Agency considers your comment(s) before it begins 
work on the final version of the guidance.

[[Page 14121]]

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-2019-D-0661 for ``Modifications to Compliance Policy for Certain 
Deemed Tobacco Products.'' Received comments 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.gpo.gov/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: Gerie Voss, Center for Tobacco 
Products, Food and Drug Administration, Document Control Center, 10903 
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 
1-877-287-1373, email: [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of March 14, 2019, 
FDA published a draft guidance for industry with a 30-day comment 
period to request comments on changes to the compliance policies for 
premarket review requirements and how FDA plans to prioritize its 
enforcement resources with regard to certain deemed tobacco products in 
the United States that do not have the required FDA premarket 
authorization for marketing. Comments on the draft guidance for 
industry will inform how FDA intends to finalize the guidance.
    The Agency has received requests for an extension of the comment 
period for the draft guidance for industry. The requests conveyed 
concern that the current 30-day comment period does not allow 
sufficient time to develop a response to the draft guidance for 
industry.
    FDA has considered the requests and is extending the comment period 
for the draft guidance for industry for 15 days, until April 30, 2019. 
The Agency believes that a 15-day extension allows adequate time for 
interested persons to submit comments without significantly delaying 
the process to finalize this guidance.

    Dated: April 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-06952 Filed 4-8-19; 8:45 am]
 BILLING CODE 4164-01-P

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