82 FR 42501 - Review of Existing Center for Tobacco Products Regulatory and Information Collection Requirements
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 173 (September 8, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 173 (September 8, 2017)
| Page Range | 42501-42503 | |
| FR Document | 2017-19035 |
[Federal Register Volume 82, Number 173 (Friday, September 8, 2017)] [Proposed Rules] [Pages 42501-42503] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-19035] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket No. FDA-2017-N-5095] Review of Existing Center for Tobacco Products Regulatory and Information Collection Requirements AGENCY: Food and Drug Administration, HHS. ACTION: Request for comments and information. ----------------------------------------------------------------------- SUMMARY: As part of the implementation of Executive Order 13771 entitled, ``Reducing Regulation and Controlling Regulatory Costs,'' and Executive Order 13777 entitled, ``Enforcing the Regulatory Reform Agenda,'' the Food and Drug Administration (FDA, Agency, or we) is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to the products regulated by the Center for Tobacco Products (CTP). DATES: Submit either electronic or written comments on this document by December 7, 2017. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 7, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 7, 2017. 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 [[Page 42502]] 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-2017-N-5095 for ``Existing Center for Tobacco Products Regulatory and Information Collection 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 Office 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.'' We will review this copy, including the claimed confidential information, in our 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.thefederalregister.org/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 Office, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Gerie Voss, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 1-877-CTP-1373, [email protected]. SUPPLEMENTARY INFORMATION: I. Background A. FDA's Regulatory Mission FDA is responsible for protecting the public health by: (1) Ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; (2) ensuring the safety, security, and appropriate labeling of our nation's food supply, products that emit radiation, and cosmetics; and (3) regulating the manufacture, marketing, and distribution of tobacco products. Equally important, FDA promotes the public health by fostering and supporting innovative approaches and solutions for some of our nation's most compelling health and medical challenges. FDA's CTP regulates the manufacture, marketing, and distribution of tobacco products. This document is seeking comments and information solely on regulations and approved information collections related to this product area. B. The Regulatory Reform Agenda: Executive Orders 13771 and 13777 On January 30, 2017, President Trump issued Executive Order 13771, ``Reducing Regulation and Controlling Regulatory Costs'' (Ref. 1). This Executive Order states that the policy of the Executive Branch is to be prudent and financially responsible in the expenditure of funds, from both public and private sources, and that it is essential to manage the costs associated with complying with Federal regulations. On February 24, 2017, President Trump issued Executive Order 13777, entitled ``Enforcing the Regulatory Reform Agenda'' (Ref. 2).[thinsp]The purpose of this Executive Order is to alleviate unnecessary regulatory burdens placed on the American people. Executive Order 13777 directs each Agency to establish a Regulatory Reform Task Force (RRTF) to evaluate existing regulations and identify those that may merit repeal, replacement, or modification. Section 3(d) of the Executive Order provides that, at a minimum, each RRTF must attempt to identify regulations that: Eliminate jobs, or inhibit job creation; Are outdated, unnecessary, or ineffective; Impose costs that exceed benefits; Create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies; Are inconsistent with the requirements of the Information Quality Act, or the guidance issued pursuant to that Act, in particular those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard for reproducibility; or Derive from or implement Executive Orders or other Presidential directives that have been subsequently rescinded or substantially modified. II. Request for Comments and Information To assist with our implementation of Executive Orders 13771 and 13777 and support the work of the RRTF of the Department of Health and Human Services, FDA is issuing this Request for Information soliciting broad public comment on ways we can change our regulations to achieve meaningful burden reduction while continuing to achieve our public health mission and fulfill statutory obligations. We request comment, including supporting technical, scientific, economic, or other data, from all persons and entities significantly affected by FDA regulations, including consumers, patients and caregivers, researchers, healthcare institutions, the regulated industry, trade associations, public interest organizations, academia, and State, local, and tribal governments, as well as any other interested stakeholder. These comments and data will supplement and inform our own ongoing, systematic review of our regulations. The following list of questions includes those that FDA is using to guide our initial review of our regulations. This list is intended to help the public in providing comments, not to restrict the issues that may be addressed. [[Page 42503]] Is the regulation still current, or is it outdated or unnecessary in some way? [cir] Have there been advancements and innovations in science, technology, or FDA or industry practice, or any other changes that suggest repeal of or modification to the regulation may be warranted or appropriate? [cir] Has the regulation been superseded or made irrelevant or unenforceable by statute, another FDA regulation or guidance, a regulation by another Federal Agency, or controlling legal authority? If yes, identify the statute, regulation, guidance, or legal precedent and explain what FDA regulation is affected and in what way it is affected. [cir] Is this regulation duplicative of requirements in other FDA regulations or other Federal Agency regulations? If yes, identify the overlapping regulation(s) and responsible Federal Agency and describe the way(s) in which the regulations overlap, as well as any suggestions with respect to how best to resolve the duplication. Have regulated entities had difficulties complying with the regulation? If yes, identify what entity or entities have had such difficulties and the nature of the difficulties. Does the regulation impose requirements that are also provided for in voluntary or consensus standards or guidance by third party organizations (e.g., International Council for Harmonisation, International Organization for Standardization, Codex Alimentarius)? Do the entities covered by these standards or guidance take steps to meet the standards and to document that they meet the standards? If met, do the standards achieve the same level of public health protection as the FDA regulation? Are there entities who are not covered by these standards or guidances or who choose not to observe them? Does the regulation contain redundant, outdated, or unnecessary collections of information or retention of records, e.g., reporting, recordkeeping, or labeling requirements? Explain in your response why the information is redundant, outdated, or unnecessary. Could the goal of the regulation be achieved by less costly means that would provide the same level of public health protection? If yes, provide examples of alternatives that may reduce costs to industry while retaining the same level of public health protection. What factors should FDA consider in selecting and prioritizing regulations and reporting requirements for reform? The most current version of FDA regulations may be found at https://www.ecfr.gov. We request that comments be as specific as possible, include any supporting data or other information, such as cost information, provide a Code of Federal Regulations (CFR) citation when referencing a specific regulation, and provide specific suggestions regarding repeal, replacement, or modification. For comments relating to an information collection, cite to the approved information collection request and include the Office of Management and Budget (OMB) control number. In addition, in order to enable us to more efficiently review and consider comments, we ask that the comments be submitted in the format shown in table 1 of this document. Table 1--Format for Submitting Comments ------------------------------------------------------------------------ Name of regulation ------------------------------------------------------------------------ Type of product or FDA Center regulating the product. Citation to Code of Federal Regulations and statutory citation (as applicable). Approved information collection and OMB Control Number (as applicable). Brief description of concern........... (For example, what innovation makes the regulation outdated? Why?) Available data on cost or economic (Quantified costs and/or cost impact. savings. Qualitative description, if needed.) Proposed solution...................... (Include your solution. For example, how would you modify the regulation? Provide specific text if you are recommending a modification.) ------------------------------------------------------------------------ III. References The following references are on display in the Dockets Management Staff Office (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. Executive Order 13771 (January 30, 2017); available at https://www.federalregister.gov/documents/2017/02/03/2017-02451/reducing-regulation-and-controlling-regulatory-costs. 2. Executive Order 13777 (February 24, 2017); available at https://www.federalregister.gov/documents/2017/03/01/2017-04107/enforcing-the-regulatory-reform-agenda. Dated: August 30, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-19035 Filed 9-7-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 173 / Friday, September 8, 2017 / Proposed Rules 42501
• Does the regulation contain the same level of public health suggestions regarding repeal,
redundant, outdated, or unnecessary protection. replacement, or modification. For
collections of information or retention • What factors should FDA consider comments relating to an information
of records, e.g., reporting, in selecting and prioritizing regulations collection, cite to the approved
recordkeeping, or labeling and reporting requirements for reform? information collection request and
requirements? Explain in your response The most current version of FDA include the Office of Management and
why the information is redundant, regulations may be found at https:// Budget (OMB) control number.
outdated, or unnecessary. www.ecfr.gov. We request that
• Could the goal of the regulation be comments be as specific as possible, In addition, in order to enable us to
achieved by less costly means that include any supporting data or other more efficiently review and consider
would provide the same level of public information, such as cost information, comments, we ask that the comments be
health protection? If yes, provide provide a Code of Federal Regulations submitted in the format shown in table
examples of alternatives that may (CFR) citation when referencing a 1 of this document.
reduce costs to industry while retaining specific regulation, and provide specific
TABLE 1—FORMAT FOR SUBMITTING COMMENTS
Name of regulation
Type of product or FDA Center regulating the product.
Citation to Code of Federal Regulations and statutory citation (as appli-
cable).
Approved information collection and OMB Control Number (as applica-
ble).
Brief description of concern ...................................................................... (For example, what innovation makes the regulation outdated? Why?)
Available data on cost or economic impact ............................................. (Quantified costs and/or cost savings. Qualitative description, if need-
ed.)
Proposed solution ..................................................................................... (Include your solution. For example, how would you modify the regula-
tion? Provide specific text if you are recommending a modification.)
III. References DEPARTMENT OF HEALTH AND ADDRESSES: You may submit comments
HUMAN SERVICES as follows. Please note that late,
The following references are on untimely filed comments will not be
display in the Dockets Management Food and Drug Administration considered. Electronic comments must
Staff Office (see ADDRESSES) and are be submitted on or before December 7,
available for viewing by interested 21 CFR Chapter I 2017. The https://www.regulations.gov
persons between 9 a.m. and 4 p.m., electronic filing system will accept
[Docket No. FDA–2017–N–5095]
Monday through Friday; they are also comments until midnight Eastern Time
available electronically at https:// Review of Existing Center for Tobacco at the end of December 7, 2017.
www.regulations.gov. FDA has verified Products Regulatory and Information Comments received by mail/hand
the Web site addresses, as of the date Collection Requirements delivery/courier (for written/paper
this document publishes in the Federal submissions) will be considered timely
AGENCY: Food and Drug Administration, if they are postmarked or the delivery
Register, but Web sites are subject to
HHS. service acceptance receipt is on or
change over time.
ACTION:Request for comments and before that date.
1. Executive Order 13771 (January 30, 2017); information.
available at https:// Electronic Submissions
www.federalregister.gov/documents/ SUMMARY: As part of the implementation
2017/02/03/2017-02451/reducing- of Executive Order 13771 entitled, Submit electronic comments in the
regulation-and-controlling-regulatory- ‘‘Reducing Regulation and Controlling following way:
costs. Regulatory Costs,’’ and Executive Order • Federal eRulemaking Portal:
2. Executive Order 13777 (February 24, 13777 entitled, ‘‘Enforcing the https://www.regulations.gov. Follow the
2017); available at https:// Regulatory Reform Agenda,’’ the Food instructions for submitting comments.
www.federalregister.gov/documents/ and Drug Administration (FDA, Agency, Comments submitted electronically,
2017/03/01/2017-04107/enforcing-the- or we) is seeking comments and including attachments, to https://
regulatory-reform-agenda. information from interested parties to www.regulations.gov will be posted to
Dated: August 30, 2017. help FDA identify existing regulations the docket unchanged. Because your
and related paperwork requirements comment will be made public, you are
Anna K. Abram,
that could be modified, repealed, or solely responsible for ensuring that your
Deputy Commissioner for Policy, Planning, replaced, consistent with the law, to
Legislation, and Analysis.
comment does not include any
achieve meaningful burden reduction confidential information that you or a
sradovich on DSK3GMQ082PROD with PROPOSALS
[FR Doc. 2017–19033 Filed 9–7–17; 8:45 am] while allowing us to achieve our public third party may not wish to be posted,
BILLING CODE 4164–01–P health mission and fulfill statutory such as medical information, your or
obligations. This document relates to anyone else’s Social Security number, or
the products regulated by the Center for confidential business information, such
Tobacco Products (CTP). as a manufacturing process. Please note
DATES: Submit either electronic or that if you include your name, contact
written comments on this document by information, or other information that
December 7, 2017. identifies you in the body of your
VerDate Sep<11>2014 16:39 Sep 07, 2017 Jkt 241001 PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 E:\FR\FM\08SEP1.SGM 08SEP1](https://thefederalregister.org/doc/82_FR_42674/page/1.svg)
![Federal Register / Vol. 82, No. 173 / Friday, September 8, 2017 / Proposed Rules 42503
• Is the regulation still current, or is or entities have had such difficulties health protection? If yes, provide
it outdated or unnecessary in some way? and the nature of the difficulties. examples of alternatives that may
Æ Have there been advancements and • Does the regulation impose reduce costs to industry while retaining
innovations in science, technology, or requirements that are also provided for the same level of public health
FDA or industry practice, or any other in voluntary or consensus standards or protection.
changes that suggest repeal of or guidance by third party organizations • What factors should FDA consider
modification to the regulation may be (e.g., International Council for in selecting and prioritizing regulations
warranted or appropriate? Harmonisation, International and reporting requirements for reform?
Æ Has the regulation been superseded Organization for Standardization, Codex
The most current version of FDA
or made irrelevant or unenforceable by Alimentarius)? Do the entities covered
regulations may be found at https://
by these standards or guidance take
statute, another FDA regulation or www.ecfr.gov. We request that
steps to meet the standards and to
guidance, a regulation by another comments be as specific as possible,
document that they meet the standards?
Federal Agency, or controlling legal include any supporting data or other
If met, do the standards achieve the
authority? If yes, identify the statute, information, such as cost information,
same level of public health protection as
regulation, guidance, or legal precedent provide a Code of Federal Regulations
the FDA regulation? Are there entities
and explain what FDA regulation is (CFR) citation when referencing a
who are not covered by these standards
affected and in what way it is affected. specific regulation, and provide specific
or guidances or who choose not to
Æ Is this regulation duplicative of observe them? suggestions regarding repeal,
requirements in other FDA regulations • Does the regulation contain replacement, or modification. For
or other Federal Agency regulations? If redundant, outdated, or unnecessary comments relating to an information
yes, identify the overlapping collections of information or retention collection, cite to the approved
regulation(s) and responsible Federal of records, e.g., reporting, information collection request and
Agency and describe the way(s) in recordkeeping, or labeling include the Office of Management and
which the regulations overlap, as well requirements? Explain in your response Budget (OMB) control number.
as any suggestions with respect to how why the information is redundant, In addition, in order to enable us to
best to resolve the duplication. outdated, or unnecessary. more efficiently review and consider
• Have regulated entities had • Could the goal of the regulation be comments, we ask that the comments be
difficulties complying with the achieved by less costly means that submitted in the format shown in table
regulation? If yes, identify what entity would provide the same level of public 1 of this document.
TABLE 1—FORMAT FOR SUBMITTING COMMENTS
Name of regulation
Type of product or FDA Center regulating the product.
Citation to Code of Federal Regulations and statutory citation (as appli-
cable).
Approved information collection and OMB Control Number (as applica-
ble).
Brief description of concern ...................................................................... (For example, what innovation makes the regulation outdated? Why?)
Available data on cost or economic impact ............................................. (Quantified costs and/or cost savings. Qualitative description, if need-
ed.)
Proposed solution ..................................................................................... (Include your solution. For example, how would you modify the regula-
tion? Provide specific text if you are recommending a modification.)
III. References 2017/03/01/2017-04107/enforcing-the- DEPARTMENT OF HEALTH AND
regulatory-reform-agenda. HUMAN SERVICES
The following references are on
Dated: August 30, 2017.
display in the Dockets Management Food and Drug Administration
Staff Office (see ADDRESSES) and are Anna K. Abram,
available for viewing by interested Deputy Commissioner for Policy, Planning, 21 CFR Chapter I
persons between 9 a.m. and 4 p.m., Legislation, and Analysis.
Monday through Friday; they are also [FR Doc. 2017–19035 Filed 9–7–17; 8:45 am] [Docket No. FDA–2017–N–5094]
available electronically at https:// BILLING CODE 4164–01–P
www.regulations.gov. FDA has verified Review of Existing Center for Food
the Web site addresses, as of the date Safety and Applied Nutrition
this document publishes in the Federal Regulatory and Information Collection
Register, but Web sites are subject to Requirements
change over time. AGENCY: Food and Drug Administration,
HHS.
sradovich on DSK3GMQ082PROD with PROPOSALS
1. Executive Order 13771 (January 30, 2017);
available at https:// ACTION:Request for comments and
www.federalregister.gov/documents/ information.
2017/02/03/2017-02451/reducing-
regulation-and-controlling-regulatory- SUMMARY: As part of the implementation
costs. of Executive Order 13771 entitled,
2. Executive Order 13777 (February 24, ‘‘Reducing Regulation and Controlling
2017); available at https:// Regulatory Costs,’’ and Executive Order
www.federalregister.gov/documents/ 13777 entitled, ‘‘Enforcing the
VerDate Sep<11>2014 16:39 Sep 07, 2017 Jkt 241001 PO 00000 Frm 00017 Fmt 4702 Sfmt 4702 E:\FR\FM\08SEP1.SGM 08SEP1](https://thefederalregister.org/doc/82_FR_42674/page/3.svg)
Document Created: 2018-10-24 14:09:42
Document Modified: 2018-10-24 14:09:42
| 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 | Proposed Rules | |
| Action | Request for comments and information. | |
| Dates | Submit either electronic or written comments on this document by December 7, 2017. | |
| Contact | Gerie Voss, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 1-877-CTP-1373, [email protected] | |
| FR Citation | 82 FR 42501 |
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