81 FR 80567 - Refuse To Accept Procedures for Premarket Tobacco Product Submissions; Withdrawal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 221 (November 16, 2016)

Page Range		80567-80567
FR Document		2016-27456

The Food and Drug Administration (FDA) published in the Federal Register of August 8, 2016, a direct final rule regarding procedures for refusing to accept premarket tobacco product submissions. The comment period closed October 24, 2016. FDA is withdrawing the direct final rule because the Agency received significant adverse comment. FDA will consider the comments we received on the direct final rule to be comments on the companion proposed rule published at 81 FR 52371 (August 8, 2016).

Federal Register, Volume 81 Issue 221 (Wednesday, November 16, 2016)

[Federal Register Volume 81, Number 221 (Wednesday, November 16, 2016)]
[Rules and Regulations]
[Page 80567]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-27456]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1105

[Docket No. FDA-2016-N-1555]


Refuse To Accept Procedures for Premarket Tobacco Product 
Submissions; Withdrawal

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) published in the 
Federal Register of August 8, 2016, a direct final rule regarding 
procedures for refusing to accept premarket tobacco product 
submissions. The comment period closed October 24, 2016. FDA is 
withdrawing the direct final rule because the Agency received 
significant adverse comment. FDA will consider the comments we received 
on the direct final rule to be comments on the companion proposed rule 
published at 81 FR 52371 (August 8, 2016).

DATES: The direct final rule published at 81 FR 52329 (August 8, 2016), 
is withdrawn effective November 16, 2016.

FOR FURTHER INFORMATION CONTACT: Annette Marthaler or Paul Hart, Office 
of Regulations, Center for Tobacco Products, Food and Drug 
Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 877-287-1373, 
CTPRegulations@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Therefore, under the Federal Food, Drug, and 
Cosmetic Act, and under authority delegated to the Commissioner of Food 
and Drugs, the direct final rule published on August 8, 2016, (81 FR 
52329) is withdrawn.

    Dated: November 9, 2016.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2016-27456 Filed 11-15-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 221 / Wednesday, November 16, 2016 / Rules and Regulations 80567

Appendix to Chief Compliance Officer Dated: November 9, 2016. (PHAs) operating in designated
Annual Report Requirements for Peter Lurie, metropolitan areas are required to use
Futures Commission Merchants, Swap Associate Commissioner for Public Health Small Area FMRs, while PHAs not
Dealers, and Major Swap Participants; Strategy and Analysis. operating in the designated areas have
Amendments to Filing Dates— [FR Doc. 2016–27456 Filed 11–15–16; 8:45 am] the option to use Small Area FMRs in
Commission Voting Summary BILLING CODE 4164–01–P administering their HCV programs.
Other programs that use FMRs would
On this matter, Chairman Massad and continue to use area-wide FMRs. This
Commissioners Bowen and Giancarlo voted
final rule also provides for regulatory
in the affirmative. No Commissioner voted in DEPARTMENT OF HOUSING AND
implementation of certain provisions of
the negative. URBAN DEVELOPMENT
the Housing Opportunity Through
[FR Doc. 2016–27525 Filed 11–15–16; 8:45 am] Modernization Act (HOTMA) related to
24 CFR Parts 888, 982, 983, and 985
BILLING CODE 6351–01–P FMRs, as well as conforming regulatory
[Docket No. FR–5855–F–03] changes to part 982 concerning the
RIN 2501–AD74 reduction in payment standards during
the term of the Housing Assistance
DEPARTMENT OF HEALTH AND Establishing a More Effective Fair Payment (HAP) contract in the HCV
HUMAN SERVICES Market Rent System; Using Small Area program. Specifically, the final rule
Fair Market Rents in the Housing provides for publication of FMRs by
Food and Drug Administration Choice Voucher Program Instead of way of the World Wide Web, and
the Current 50th Percentile FMRs provides that PHAs are no longer
21 CFR Part 1105 required to reduce the payment
AGENCY: Office of the Secretary, HUD. standard for a family under HAP
[Docket No. FDA–2016–N–1555] ACTION: Final rule. contract when the PHA is required to
reduce the payment standard for its
Refuse To Accept Procedures for SUMMARY: This final rule applies the use program as the result of a reduction in
Premarket Tobacco Product of Small Area Fair Market Rents (Small the FMR.
Submissions; Withdrawal Area FMRs) in the administration of the
Housing Choice Voucher (HCV) program I. Executive Summary
AGENCY: Food and Drug Administration, for certain metropolitan areas. This final A. Purpose of the Regulatory Action
HHS. rule provides for the use of Small Area
FMRs, in place of the 50th percentile This final rule establishes a more
ACTION: Direct final rule; withdrawal. rent, the currently codified regulations, effective means for HCV tenants to move
to address high levels of voucher into areas of higher opportunity and
SUMMARY: The Food and Drug concentration in certain communities. lower poverty by providing the tenants
Administration (FDA) published in the The use of Small Area FMRs is expected with a subsidy adequate to make such
Federal Register of August 8, 2016, a to give HCV tenants access to areas of areas accessible and, consequently, help
direct final rule regarding procedures high opportunity and lower poverty reduce the number of voucher families
for refusing to accept premarket tobacco areas by providing a subsidy that is that reside in areas of high poverty
product submissions. The comment adequate to cover rents in those areas, concentration. Prior to this rule, subsidy
period closed October 24, 2016. FDA is thereby reducing the number of voucher for HUD’s HCV program is determined
withdrawing the direct final rule families that reside in areas of high by a formula that considers rent prices
because the Agency received significant poverty concentration. across an entire metropolitan area.
adverse comment. FDA will consider However, rents can vary widely within
DATES: Effective: January 17, 2017.
the comments we received on the direct a metropolitan area depending upon the
FOR FURTHER INFORMATION CONTACT: For size of the metropolitan area and the
final rule to be comments on the information about this rule, contact
companion proposed rule published at neighborhood in the metropolitan area
Peter B. Kahn, Director, Economic and within which one resides. The result of
81 FR 52371 (August 8, 2016). Market Analysis Division, Office of determining rents on the basis of an
DATES: The direct final rule published at Economic Affairs, Office of Policy entire metropolitan area is that a
81 FR 52329 (August 8, 2016), is Development and Research, U.S. voucher subsidy may be too high or may
withdrawn effective November 16, 2016. Department of Housing and Urban be too low to cover market rent in a
Development, 451 7th Street SW., given neighborhood. To date, HUD’s
FOR FURTHER INFORMATION CONTACT: Washington, DC 20410, telephone (202) policy for addressing high
Annette Marthaler or Paul Hart, Office 402–2409 or Becky L. Primeaux, concentrations of voucher holders raises
of Regulations, Center for Tobacco Director, Housing Voucher Management the level of the FMR from the 40th
Products, Food and Drug and Operations Division, U.S. percentile to the 50th percentile
Administration, Document Control Department of Housing and Urban (roughly a 7—8 percent increase) in the
Center, Bldg. 71, Rm. G335, 10903 New Development, 451 7th Street SW., whole FMR area. This level of added
Hampshire Ave., Silver Spring, MD Washington, DC 20410, telephone (202) subsidy has not been targeted to areas of
20993–0002, 877–287–1373, 708–0477; email: SAFMR_Rule@ opportunity, and consequently, this
CTPRegulations@fda.hhs.gov. hud.gov. The listed telephone numbers formula has not proven effective in
mstockstill on DSK3G9T082PROD with RULES

SUPPLEMENTARY INFORMATION: Therefore, are not toll-free numbers. Persons with addressing the problem of concentrated
under the Federal Food, Drug, and hearing or speech impairments may poverty and economic and racial
Cosmetic Act, and under authority access this number through TTY by segregation in neighborhoods.
delegated to the Commissioner of Food calling Federal Relay Service at (800) Experience with the 50th percentile
and Drugs, the direct final rule 877–8339 (this is a toll-free number). regime has shown that the majority of
published on August 8, 2016, (81 FR SUPPLEMENTARY INFORMATION: Under this HCV tenants use their vouchers in
52329) is withdrawn. final rule, public housing agencies neighborhoods where rents are low but

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Document Created: 2016-11-16 00:57:08
Document Modified: 2016-11-16 00:57:08

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		Rules and Regulations
Action		Direct final rule; withdrawal.
Dates		The direct final rule published at 81 FR 52329 (August 8, 2016), is withdrawn effective November 16, 2016.
Contact		Annette Marthaler or Paul Hart, Office of Regulations, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 877-287-1373, [email protected]
FR Citation		81 FR 80567

81 FR 80567 - Refuse To Accept Procedures for Premarket Tobacco Product Submissions; Withdrawal

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 221 (November 16, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration