Modified Risk Tobacco Product Applications for Snus Products Submitted by Swedish Match North America Inc.; Reopening of the Comment Period, 54362-54363 [2018-23524]

Download as PDF 54362 Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: October 23, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–23527 Filed 10–26–18; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1051] Modified Risk Tobacco Product Applications for Snus Products Submitted by Swedish Match North America Inc.; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. Notice; reopening of the comment period. 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’’). ACTION: Written/Paper Submissions The Food and Drug Administration (FDA or the Agency) is reopening the period for public comment on modified risk tobacco product applications (MRTPAs) for specific General Snus products submitted by Swedish Match North America Inc. and announcing the availability for public comment of a recently received amendment to the MRTPAs. The original notice of availability for the applications appeared in the Federal Register of August 27, 2014. In that notice, FDA requested comments on the originally filed MRTPAs that are posted on https:// www.regulations.gov and FDA’s website. In the Federal Register of July 31, 2015, FDA issued a notice to reopen and extended the comment period for comments on amendments to the MRTPAs. That comment period closed on August 31, 2015. FDA is now reopening the comment period to seek comment specifically on a recent amendment to the MRTPAs. 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– 2014–N–1051 for ‘‘Modified Risk Tobacco Product Applications for Snus Products Submitted by Swedish Match North America Inc.’’ 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. SUMMARY: amozie on DSK3GDR082PROD with NOTICES1 Electronic or written comments on the application may be submitted beginning October 29, 2018. FDA will establish a closing date for the comment period as described in section I. ADDRESSES: You may submit comments as follows: DATES: VerDate Sep<11>2014 17:48 Oct 26, 2018 Jkt 247001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 • 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/201523389.pdf. Docket: For access to the docket to read 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: Paul Hart, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993–0002, 1–877– 287–1373, email: AskCTP@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of August 27, 2014 (79 FR 51183), FDA published a notice of availability for MRTPAs submitted by Swedish Match North America Inc. and gave the public 180 days to comment on the applications. FDA subsequently published a notice in the Federal Register of July 31, 2015 (80 FR 45661), to reopen and extend the comment period to allow for comment on amendments to the applications. The comment period closed on August 31, 2015. On December 14, 2016, FDA E:\FR\FM\29OCN1.SGM 29OCN1 amozie on DSK3GDR082PROD with NOTICES1 Federal Register / Vol. 83, No. 209 / Monday, October 29, 2018 / Notices issued a letter to Swedish Match North America Inc. that denied the MRTPAs, in part, and outlined deficiencies in the remaining portions of the MRTPAs that the applicant could address by submitting an amendment to the applications. FDA recently received an amendment to Swedish Match North America Inc.’s MRTPAs and is making the amendment available (except for matters in the amendment that are trade secrets or otherwise confidential commercial information) for public comment. FDA is reopening the period for public comment so that the public has the opportunity to review and comment on the amendment. FDA is required by section 911(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387k(e)) to make an MRTPA available to the public (except for matters in the application that are trade secrets or otherwise confidential commercial information) and to request comments by interested persons on the information contained in the application and on the label, labeling, and advertising accompanying the application. The determination of whether an order is appropriate under section 911 of the FD&C Act is based on the scientific information submitted by the applicant as well as the scientific evidence and other information that is made available to the Agency, including through public comments. FDA has posted the application amendment for public comment, which has been redacted in accordance with applicable laws. FDA intends to establish a closing date for the comment period that is at least 30 days after the final documents from the application are made available for public comment and will announce the closing date at least 30 days in advance. FDA will notify the public about the availability of additional application documents, if any, and the closing date for the comment period via the Agency’s web page for the MRTPA (see section II) and by other means of public communication, such as by email to individuals who have signed up to receive email alerts. FDA does not intend to issue additional notices in the Federal Register regarding amendments or the comment period for these MRTPAs. To receive email alerts, visit FDA’s email subscription service management website (http://go.fda.gov/ subscriptionmanagement), provide an email address, scroll down to the ‘‘Tobacco’’ heading, select ‘‘Modified Risk Tobacco Product Application Updates’’, and click ‘‘Submit’’. To encourage public participation consistent with section 911(e) of the FD&C Act, FDA is making the redacted VerDate Sep<11>2014 17:48 Oct 26, 2018 Jkt 247001 MRTPAs that are the subject of this notice available electronically (see section II). II. Electronic Access Persons with access to the internet may obtain the documents at either https://www.fda.gov/TobaccoProducts/ Labeling/MarketingandAdvertising/ ucm533454.htm or https:// www.regulations.gov. Dated: October 23, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–23524 Filed 10–26–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Ryan White HIV/AIDS Program Client-Level Data Reporting System, OMB No. 0906–xxxx–NEW Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this ICR should be received no later than November 28, 2018. SUMMARY: Submit your comments, including the ICR Title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to (202) 395–5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443– 1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: Client-Level Data Reporting System. OMB No. 0906–xxxx–NEW. Abstract: The Ryan White HIV/AIDS Program’s (RWHAP) client-level data ADDRESSES: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 54363 reporting system, entitled the RWHAP Services Report or the Ryan White Services Report (RSR), is designed to collect information from grant recipients, as well as their subrecipients, funded under Parts A, B, C, and D of the RWHAP statute. The RWHAP, authorized under Title XXVI of the Public Health Service Act, as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009, is administered by HRSA HIV/AIDS Bureau (HAB). The HRSA RWHAP funds and coordinates with cities, states, and local clinics/communitybased organizations to deliver efficient and effective HIV care, treatment, and support to low-income people living with HIV (PLWH). Need and Proposed Use of the Information: The RWHAP statute requires HRSA to monitor the administration of grant funds, allocation of funding, service utilization, and client demographic and HIV health outcome data (e.g., viral suppression). The RSR collects data on the characteristics of RWHAP-funded recipients, subrecipients, and the patients or clients served. The RSR system consists of two online data forms: the Recipient Report and the Service Provider Report; and the Client Report, which is a data file containing the client-level data elements. Data are submitted annually. The RWHAP statute specifies the importance of recipient accountability and linking performance to budget. The RSR is used to ensure recipient compliance with the statute, including evaluating the effectiveness of programs, monitoring recipient and subrecipient performance, and informing annual reports to Congress. Information collected through the RSR is critical for HRSA, state/local grant recipients, and individual service providers to understand existing HIVrelated service delivery systems and the clients served. Information in the RSR is used to assess trends in service utilization and HIV health outcomes for clients served. Data from the RSR is analyzed to identify disparities and gaps within the service delivery systems. The 60-day notice published on November 27, 2017 (Vol. 82, No. 226). This new ICR is being developed to replace the existing ICR (OMB control number 0915–0323), for which HRSA has collected RSR data since 2009. As more recipients fully fund services using other RWHAP-related funding streams, such as pharmacy rebate dollars, HRSA HAB receives less information on RWHAP eligible clients, which reduces HRSA HAB’s ability to measure the investment and impact of all RWHAP-related expenditures at state E:\FR\FM\29OCN1.SGM 29OCN1

Agencies

[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)]
[Notices]
[Pages 54362-54363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23524]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1051]


Modified Risk Tobacco Product Applications for Snus Products 
Submitted by Swedish Match North America Inc.; Reopening of the Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reopening the period for public comment on modified risk tobacco 
product applications (MRTPAs) for specific General Snus products 
submitted by Swedish Match North America Inc. and announcing the 
availability for public comment of a recently received amendment to the 
MRTPAs. The original notice of availability for the applications 
appeared in the Federal Register of August 27, 2014. In that notice, 
FDA requested comments on the originally filed MRTPAs that are posted 
on https://www.regulations.gov and FDA's website. In the Federal 
Register of July 31, 2015, FDA issued a notice to reopen and extended 
the comment period for comments on amendments to the MRTPAs. That 
comment period closed on August 31, 2015. FDA is now reopening the 
comment period to seek comment specifically on a recent amendment to 
the MRTPAs.

DATES: Electronic or written comments on the application may be 
submitted beginning October 29, 2018. FDA will establish a closing date 
for the comment period as described in section I.

ADDRESSES: You may submit comments as follows:

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-2014-N-1051 for ``Modified Risk Tobacco Product Applications for 
Snus Products Submitted by Swedish Match North America Inc.'' 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 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: Paul Hart, Center for Tobacco 
Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. G335, Silver Spring, MD 20993-0002, 1-877-287-1373, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 27, 2014 (79 FR 51183), FDA 
published a notice of availability for MRTPAs submitted by Swedish 
Match North America Inc. and gave the public 180 days to comment on the 
applications. FDA subsequently published a notice in the Federal 
Register of July 31, 2015 (80 FR 45661), to reopen and extend the 
comment period to allow for comment on amendments to the applications. 
The comment period closed on August 31, 2015. On December 14, 2016, FDA

[[Page 54363]]

issued a letter to Swedish Match North America Inc. that denied the 
MRTPAs, in part, and outlined deficiencies in the remaining portions of 
the MRTPAs that the applicant could address by submitting an amendment 
to the applications. FDA recently received an amendment to Swedish 
Match North America Inc.'s MRTPAs and is making the amendment available 
(except for matters in the amendment that are trade secrets or 
otherwise confidential commercial information) for public comment. FDA 
is reopening the period for public comment so that the public has the 
opportunity to review and comment on the amendment.
    FDA is required by section 911(e) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 387k(e)) to make an MRTPA available 
to the public (except for matters in the application that are trade 
secrets or otherwise confidential commercial information) and to 
request comments by interested persons on the information contained in 
the application and on the label, labeling, and advertising 
accompanying the application. The determination of whether an order is 
appropriate under section 911 of the FD&C Act is based on the 
scientific information submitted by the applicant as well as the 
scientific evidence and other information that is made available to the 
Agency, including through public comments.
    FDA has posted the application amendment for public comment, which 
has been redacted in accordance with applicable laws. FDA intends to 
establish a closing date for the comment period that is at least 30 
days after the final documents from the application are made available 
for public comment and will announce the closing date at least 30 days 
in advance. FDA will notify the public about the availability of 
additional application documents, if any, and the closing date for the 
comment period via the Agency's web page for the MRTPA (see section II) 
and by other means of public communication, such as by email to 
individuals who have signed up to receive email alerts. FDA does not 
intend to issue additional notices in the Federal Register regarding 
amendments or the comment period for these MRTPAs. To receive email 
alerts, visit FDA's email subscription service management website 
(http://go.fda.gov/subscriptionmanagement), provide an email address, 
scroll down to the ``Tobacco'' heading, select ``Modified Risk Tobacco 
Product Application Updates'', and click ``Submit''. To encourage 
public participation consistent with section 911(e) of the FD&C Act, 
FDA is making the redacted MRTPAs that are the subject of this notice 
available electronically (see section II).

II. Electronic Access

    Persons with access to the internet may obtain the documents at 
either https://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm533454.htm or https://www.regulations.gov.

    Dated: October 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23524 Filed 10-26-18; 8:45 am]
BILLING CODE 4164-01-P