more government gobbleby-....!!!

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mad maori

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RIN Data
HHS/FDA RIN: 0910-AG38 Publication ID: Spring 2013
Title: "tobacco Products" Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and tobacco Control Act
Abstract: The Family Smoking Prevention and tobacco Control Act (Tobacco Control Act) provides the Food and Drug Administration (FDA) authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco products to be subject to the FD&C Act. This proposed rule would deem products meeting the statutory definition of "tobacco product" to be subject to the FD&C Act and would specify additional restrictions.
Agency: Department of Health and Human Services(HHS) Priority: Economically Significant
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage
Major: Yes Unfunded Mandates: Private Sector
CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and Cosmetic Act; PL 111-31, The Family Smoking Prevention and Tobacco Control Act
Legal Deadline: None
Timetable:
Action Date FR Cite
NPRM 10/00/2013
Regulatory Flexibility Analysis Required: Yes Government Levels Affected: Undetermined
Small Entities Affected: Businesses Federalism: Undetermined
Included in the Regulatory Plan: No
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes
Agency Contact:
May Nelson
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
HFS-32, Center for Tobacco Products, 9200 Corporate Boulevard,
Rockville, MD 20850
Phone:877 287-1373
Fax:240 276-3904
Email: may.nelson@fda.hhs.gov
 
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BFP for Value

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http://www.reginfo.gov/public/do/eA...&RIN=0910-AG38&operation=OPERATION_PRINT_RULE

Notice that all this doc says is that there will be an NPRM set for October of this year. According to the following definition, I think this will be the time period for which the rule will be subject to public notice and comment. Either that, or it may mark the deadline for public comment. If the latter is true then that may mean that the time to make public comments is now and until 10/00/2013! I don't think so, because it seems to me as though this document is merely a notice of a notice, but I'm not exactly an expert on NPRMs. Perhaps the individual whose name appears in this notice could clarify.

"Proposed Rule/Notice of Proposed Rulemaking (NPRM): An agency process, subject to public notice and comment, for formulating, amending, or withdrawing a regulation. A proposed rule provides FDA’s suggested regulatory changes to the CFR. It also provides the public with notice of and an opportunity to comment on the regulatory changes being undertaken by the agency."

http://www.fda.gov/downloads/Biolog...toryInformation/ProceduresSOPPs/UCM135489.pdf
 
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Bill Godshall

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Thanks for posting weblink to this document.

It appears that the FDA has once again extended the time it tentatively plans to propose the "deeming" regulation.

Please remember that the FDA has previously stated that it would propose the "deeming" regulation in October 2011, in the Summer of 2012, and in April, 2013.

We need to continue convincing the FDA that it would be best for consumer and public health for the agency to NOT propose a "deeming" regulation.
 
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