Premarket Tobacco Product Applications and Recordkeeping Requirements; Reopening of the Comment Period, 65044-65045 [2019-25675]

Download as PDF 65044 Federal Register / Vol. 84, No. 228 / Tuesday, November 26, 2019 / Proposed Rules § 408.618 Advance designation of representative payees. For information about advance designation, how to designate representative payees in advance, how to make changes to advance designations, how we consider an advance designation when we select a representative payee, how we consider an advance designation when we select a subsequent representative payee, and other relevant information, see §§ 404.2018, 404.2020, and 404.2021 of this chapter. PART416—SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED 7. The authority citation for subpart F of part 416 is revised to read as follows: ■ Authority: Secs. 205(j)(1)(C), 702(a)(5), 1631(a)(2) and (d)(1) of the Social Security Act (42 U.S.C. 405(j)(1)(C), 902(a)(5), 1383(a)(2) and (d)(1)). 8. Add § 416.618 to subpart F to read as follows: ■ § 416.618 Advance designation of representative payees. (a) General. An individual who: (1) Is eligible for or an applicant for a benefit; and (2) Has attained 18 years of age or is an emancipated minor, may designate in advance one or more individuals to possibly serve as a representative payee for the individual if we determine that payment will be made to a representative payee (see § 416.610(a)). An individual may not designate in advance possible representative payees if we have information that the individual is either legally incompetent or mentally incapable of managing his or her benefit payments; or physically incapable of managing or directing the management of his or her benefit payments. (b) How to designate possible representative payees in advance. Individuals who meet the requirements in paragraph (a) of this section may designate in advance their choice(s) for possible representative payees by indicating their decision to designate a representative payee in advance and providing us with the required information. In addition to the required information, an individual may choose to provide us with the relationship of the advance designee to the individual. The information we require before we will consider an advance designee as a possible representative payee is: (1) The name of the advance designee, (2) A telephone number of the advance designee, and (3) The order of priority in which the individual would like us to consider the VerDate Sep<11>2014 17:02 Nov 25, 2019 Jkt 250001 advance designees if he or she designates more than one advance designee. (c) How to make changes to advance designation. Individuals who meet the requirements in paragraph (a) of this section may change their advance designees by informing us of the change and providing the required information (see paragraph (b)(1) through (3) of this section) to us. Individuals who meet the requirements in paragraph (a) of this section may withdraw their advance designation by informing us of the withdrawal. (d) How we consider advance designation when we select a representative payee. (1) If we determine that payment will be made to a representative payee, we will review advance designees in the order listed by the individual and select the first advance designee who meets the criteria for selection. To meet the criteria for selection— (i) The advance designee must be willing and able to serve as a representative payee, (ii) Appointment of the advance designee must comply with the requirements in section 205(j)(2) of the Social Security Act, and (iii) There must be no other good cause (see §§ 416.620 and 416.621) to prevent us from selecting the advance designee. (2) If none of the advance designees meet the criteria for selection, we will use our list of categories of preferred payees (see § 416.621), along with our other regulations in subpart F of this part, as a guide to select a suitable representative payee. (e) How we consider advance designation when we select a subsequent representative payee. If an individual who currently has a representative payee requires a change of representative payee, we will consider any other designees identified by the individual at a time in which that individual was eligible to make an advanced designation, under paragraph (d) of this section. (f) Organizations. An individual may not designate in advance an organization to serve as his or her possible representative payee. ■ 9. Amend § 416.620 by ■ a. Revising paragraphs (e) and (f), and ■ b. Adding paragraph (g): The revisions and addition reads as follows: § 416.620 Information considered in selecting a representative payee. * * * * * (e) Whether the potential payee is in a position to know of and look after the needs of the beneficiary; PO 00000 Frm 00024 Fmt 4702 Sfmt 4702 (f) The potential payee’s criminal history; and (g) Whether the beneficiary made an advance designation (see § 416.618). ■ 10. Amend § 416.621 by revising the introductory paragraph to read as follows: § 416.621 What is our order of preference in selecting a representative payee for you? As a guide in selecting a representative payee, we have established categories of preferred payees. These preferences are flexible. We will consider an individual’s advance designees (see § 416.618) before we consider other potential representative payees in the categories of preferred payees listed in this section. When we select a representative payee, we will choose the designee of the beneficiary’s highest priority, provided that the designee is willing and able to serve, is not prohibited from serving (see § 416.622), and supports the best interest of the beneficiary (see § 416.620). The preferences are: * * * * * [FR Doc. 2019–25569 Filed 11–25–19; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1100, 1107, and 1114 [Docket No. FDA–2019–N–2854] RIN 0910–AH44 Premarket Tobacco Product Applications and Recordkeeping Requirements; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. Proposed rule; reopening of the comment period. ACTION: The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the proposed rulemaking that appeared in the Federal Register of September 25, 2019. The Agency is taking this action in response to a request for an extension to the comment period to allow interested persons additional time to submit comments. DATES: FDA is reopening the comment period on the proposed rule published September 25, 2019 (84 FR 50566). Submit either electronic or written comments December 16, 2019. ADDRESSES: You may submit comments as follows. Please note that late, SUMMARY: E:\FR\FM\26NOP1.SGM 26NOP1 Federal Register / Vol. 84, No. 228 / Tuesday, November 26, 2019 / Proposed Rules untimely filed comments will not be considered. Electronic comments must be submitted on or before December 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 16, 2019. 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– 2019–N–2854 for ‘‘Premarket Tobacco Product Applications and Recordkeeping Requirements.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for VerDate Sep<11>2014 17:02 Nov 25, 2019 Jkt 250001 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/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: Paul Hart, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993–0002, 877– 287–1373, email: AskCTP@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of September 25, 2019, FDA published a proposed rule that would, if finalized, establish requirements related to the content and format of premarket tobacco product applications, application review procedures, and recordkeeping. Interested persons were originally given PO 00000 Frm 00025 Fmt 4702 Sfmt 4702 65045 until November 25, 2019, to comment on the proposed rule. Following publication of the proposed rule in the Federal Register of September 25, 2019, FDA received a request to allow interested persons additional time to comment. The requester asserted that the time period of 60 days was insufficient to allow potential respondents to thoroughly evaluate and address pertinent issues. FDA has considered the request and is reopening the comment period for the proposed rule for 20 days. The Agency believes that a 20-day reopening of the comment period allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues. Dated: November 21, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–25675 Filed 11–25–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG–2019–0824] RIN 1625–AA09 Drawbridge Operation Regulation; Milwaukee, Menomonee, and Kinnickinnic Rivers and Burnham Canals. Milwaukee, WI Coast Guard, DHS. Advanced Notice of Proposed Rulemaking request for comments. AGENCY: ACTION: The Coast Guard is seeking information and comments on a Notice of Proposed Rulemaking with a test schedule for the bridges crossing the Milwaukee, Menomonee, and Kinnickinnic Rivers and South Menomonee and Burnham Canals. The City of Milwaukee requested the regulations to be reviewed and updated to allow for a more balanced flow of maritime and land based transportation. The current regulation has been in place for over 30 years and is obsolete. DATES: Comments and related materials must reach the Coast Guard on or before: January 27, 2020. ADDRESSES: You may submit comments identified by docket number USCG– 2019–0824 using Federal eRulemaking Portal at https://www.regulations.gov. See the ‘‘Public Participation and Request for Comments’’ portion of the SUMMARY: E:\FR\FM\26NOP1.SGM 26NOP1

Agencies

[Federal Register Volume 84, Number 228 (Tuesday, November 26, 2019)]
[Proposed Rules]
[Pages 65044-65045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25675]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1100, 1107, and 1114

[Docket No. FDA-2019-N-2854]
RIN 0910-AH44


Premarket Tobacco Product Applications and Recordkeeping 
Requirements; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reopening the comment period for the proposed rulemaking that appeared 
in the Federal Register of September 25, 2019. The Agency is taking 
this action in response to a request for an extension to the comment 
period to allow interested persons additional time to submit comments.

DATES: FDA is reopening the comment period on the proposed rule 
published September 25, 2019 (84 FR 50566). Submit either electronic or 
written comments December 16, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,

[[Page 65045]]

untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 16, 2019. 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-2019-N-2854 for ``Premarket Tobacco Product Applications and 
Recordkeeping Requirements.'' 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.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: Paul Hart, Center for Tobacco 
Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. G335, Silver Spring, MD 20993-0002, 877-287-1373, email: 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of September 25, 
2019, FDA published a proposed rule that would, if finalized, establish 
requirements related to the content and format of premarket tobacco 
product applications, application review procedures, and recordkeeping. 
Interested persons were originally given until November 25, 2019, to 
comment on the proposed rule.
    Following publication of the proposed rule in the Federal Register 
of September 25, 2019, FDA received a request to allow interested 
persons additional time to comment. The requester asserted that the 
time period of 60 days was insufficient to allow potential respondents 
to thoroughly evaluate and address pertinent issues. FDA has considered 
the request and is reopening the comment period for the proposed rule 
for 20 days. The Agency believes that a 20-day reopening of the comment 
period allows adequate time for interested persons to submit comments 
without significantly delaying rulemaking on these important issues.

    Dated: November 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25675 Filed 11-25-19; 8:45 am]
BILLING CODE 4164-01-P

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