80 FR 65229 - National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions-Small Entity Compliance Guide; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 206 (October 26, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 206 (October 26, 2015)
| Page Range | 65229-65231 | |
| FR Document | 2015-27111 |
[Federal Register Volume 80, Number 206 (Monday, October 26, 2015)] [Notices] [Pages 65229-65231] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27111] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1282] National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions--Small Entity Compliance Guide; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions--Small Entity Compliance Guide.'' This guidance is intended to help small businesses understand the recent changes to FDA's National Environmental Policy Act (NEPA)-implementing regulations, which will allow certain classes of actions on tobacco product marketing applications to be excluded from the requirements to prepare an environmental assessment (EA) or an environmental impact statement (EIS). This will decrease the amount of time required for industry to complete, and for FDA to review, applications. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the [[Page 65230]] instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2013-N-1282 for ``National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions--Small Entity Compliance Guide.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of this guidance to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the guidance document may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Katherine Collins, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, CTPRegulations@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions--Small Entity Compliance Guide.'' This guidance is intended to help small businesses understand and comply with FDA's implementation of NEPA and the Council on Environmental Quality (CEQ) regulations for classes of actions for tobacco products as provided by the final rule. Specifically, this guidance is intended to help small businesses understand which classes of actions for tobacco products require at least the preparation of an EA, and how to apply for categorical exclusions if they qualify based on their particular circumstance. NEPA and CEQ regulations require each Federal Agency to assess, as an integral part of its decisionmaking process, the environmental impacts of any proposed Federal action to ascertain the environmental consequences of that action on the quality of the human environment and to ensure that the interested and affected public is appropriately informed (42 U.S.C. 4332(2); 40 CFR 1506.6). FDA regulations governing its responsibilities under NEPA are codified at 21 CFR part 25, and the CEQ regulations are codified at 40 CFR parts 1500 to 1508. CEQ oversees FDA's compliance with NEPA. For major Federal actions that may have a significant environmental impact, FDA can either prepare an EIS or prepare an EA. An EA provides sufficient information and analysis for FDA to determine whether to prepare an EIS or issue a finding of no significant impact (21 CFR 25.20; 40 CFR 1501.4). FDA is responsible for the scope and content of an EA and generally requires an applicant to prepare an EA and make necessary corrections to it (21 CFR 25.40(b)). Categorically excluded actions refer to a category of actions that have been found not to individually or cumulatively have a significant effect on the quality of the human environment and which do not normally require the preparation of an EA or EIS (40 CFR 1508.4). However, as required under 21 CFR 25.21 and 40 CFR 1508.4, FDA will require preparation of at least an EA for any specific action that normally would be excluded if extraordinary circumstances are present such that the specific proposed action may have the potential to significantly affect the quality of the human environment. In compliance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121), FDA is making available this small entity compliance guide stating in plain language the legal requirements of the September 24, 2015, final rule, set forth in 21 CFR part 25. II. Significance of Guidance This guidance is being issued consistent with FDA's good guidance [[Page 65231]] practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on NEPA and environmental assessments for tobacco products including categorical exclusions. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Electronic Access Persons with access to the Internet may obtain an electronic version of the guidance at either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm. Dated: October 20, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-27111 Filed 10-23-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 206 / Monday, October 26, 2015 / Notices 65229
ACTION: Notice. 3. Call the Reports Clearance Office at CMS–10280 (OMB control number:
(410) 786–1326. 0938–0829); Frequency: Occasionally;
SUMMARY: The Centers for Medicare & Affected Public: Private sector (Business
FOR FURTHER INFORMATION CONTACT:
Medicaid Services (CMS) is announcing or other for-profits and Not-for-profit
Reports Clearance Office at (410) 786–
an opportunity for the public to institutions); Number of Respondents:
1326.
comment on CMS’ intention to collect 12,459; Total Annual Responses:
information from the public. Under the SUPPLEMENTARY INFORMATION:
13,764,434; Total Annual Hours:
Paperwork Reduction Act of 1995 (the Contents 917,262. (For policy questions regarding
PRA), federal agencies are required to this collection contact Evelyn Blaemire
publish notice in the Federal Register This notice sets out a summary of the
use and burden associated with the at 410–786–1803).
concerning each proposed collection of
following information collections. More Dated: October 20, 2015.
information (including each proposed
extension or reinstatement of an existing detailed information can be found in William N. Parham, III,
collection of information) and to allow each collection’s supporting statement Director, Paperwork Reduction Staff, Office
60 days for public comment on the and associated materials (see of Strategic Operations and Regulatory
ADDRESSES). Affairs.
proposed action. Interested persons are
invited to send comments regarding our [FR Doc. 2015–27077 Filed 10–23–15; 8:45 am]
CMS–10280 Home Health Change of
burden estimates or any other aspect of Care Notice (HHCCN) BILLING CODE 4120–01P
this collection of information, including
any of the following subjects: (1) The Under the PRA (44 U.S.C. 3501–
necessity and utility of the proposed 3520), federal agencies must obtain DEPARTMENT OF HEALTH AND
information collection for the proper approval from the Office of Management HUMAN SERVICES
performance of the agency’s functions; and Budget (OMB) for each collection of
information they conduct or sponsor. Food and Drug Administration
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality, The term ‘‘collection of information’’ is [Docket No. FDA–2013–N–1282]
utility, and clarity of the information to defined in 44 U.S.C. 3502(3) and 5 CFR
be collected; and (4) the use of 1320.3(c) and includes agency requests National Environmental Policy Act;
automated collection techniques or or requirements that members of the Environmental Assessments for
other forms of information technology to public submit reports, keep records, or Tobacco Products; Categorical
minimize the information collection provide information to a third party. Exclusions—Small Entity Compliance
burden. Section 3506(c)(2)(A) of the PRA Guide; Guidance for Industry;
requires federal agencies to publish a Availability
DATES: Comments must be received by 60-day notice in the Federal Register
December 28, 2015. concerning each proposed collection of AGENCY: Food and Drug Administration,
ADDRESSES: When commenting, please information, including each proposed HHS.
reference the document identifier or extension or reinstatement of an existing ACTION: Notice of availability.
OMB control number. To be assured collection of information, before
SUMMARY: The Food and Drug
consideration, comments and submitting the collection to OMB for
Administration (FDA) is announcing the
recommendations must be submitted in approval. To comply with this
availability of a guidance for industry
any one of the following ways: requirement, CMS is publishing this
1. Electronically. You may send your entitled ‘‘National Environmental Policy
notice.
comments electronically to http:// Act; Environmental Assessments for
www.regulations.gov. Follow the Information Collection Tobacco Products; Categorical
instructions for ‘‘Comment or 1. Type of Information Collection Exclusions—Small Entity Compliance
Submission’’ or ‘‘More Search Options’’ Request: Extension of a currently Guide.’’ This guidance is intended to
to find the information collection approved collection; Title of help small businesses understand the
document(s) that are accepting Information Collection: Home Health recent changes to FDA’s National
comments. Change of Care Notice (HHCCN); Use: Environmental Policy Act (NEPA)-
2. By regular mail. You may mail The Home Health Change of Care Notice implementing regulations, which will
written comments to the following (HHCCN) is used to notify original allow certain classes of actions on
address: CMS, Office of Strategic Medicare beneficiaries receiving home tobacco product marketing applications
Operations and Regulatory Affairs, health care benefits of plan of care to be excluded from the requirements to
Division of Regulations Development, changes. Home health agencies (HHAs) prepare an environmental assessment
Attention: Document Identifier/OMB must provide the HHCCN whenever (EA) or an environmental impact
Control Number lll, Room C4–26– they reduce or terminate a beneficiary’s statement (EIS). This will decrease the
05, 7500 Security Boulevard, Baltimore, home health services due to physician/ amount of time required for industry to
Maryland 21244–1850. provider orders or limitation of the HHA complete, and for FDA to review,
To obtain copies of a supporting in providing the specific service. applications.
statement and any related forms for the Notification is required for covered and DATES: Submit either electronic or
proposed collection(s) summarized in non-covered services listed in the plan written comments on Agency guidances
this notice, you may make your request of care. This iteration contains non- at any time.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
using one of following: substantive changes which add language ADDRESSES: You may submit comments
1. Access CMS’ Web site address at informing beneficiaries of their rights as follows:
http://www.cms.hhs.gov/ under Section 504 of the Rehabilitation
PaperworkReductionActof1995. Act of 1973 by alerting the beneficiary Electronic Submissions
2. Email your request, including your to CMS’ nondiscrimination practices Submit electronic comments in the
address, phone number, OMB number, and the availability of alternate forms of following way:
and CMS document identifier, to this notice if needed. There are no • Federal eRulemaking Portal: http://
Paperwork@cms.hhs.gov. substantive changes. Form Number: www.regulations.gov. Follow the
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![Federal Register / Vol. 80, No. 206 / Monday, October 26, 2015 / Notices 65231
practices regulation (21 CFR 10.115). Name of Committee: National Institute of Scientific Review, National Institute of
The guidance represents the current Diabetes and Digestive and Kidney Diseases General Medical Sciences, National Institutes
thinking of FDA on NEPA and Special Emphasis Panel; Treatments for Fecal of Health, 45 Center Drive, Room 3An.12N,
Incontinence. Bethesda, MD 20892, 301–594–3663,
environmental assessments for tobacco weidmanma@nigms.nih.gov.
Date: December 2, 2015.
products including categorical Time: 2:00 p.m. to 4:00 p.m. Name of Committee: National Institute of
exclusions. It does not establish any Agenda: To review and evaluate grant General Medical Sciences Special Emphasis
rights for any person and is not binding applications. Panel; NIGMS Support of Competitive
on FDA or the public. You can use an Place: National Institutes of Health, Two Research (SCORE) Awards.
alternative approach if it satisfies the Democracy Plaza, 6707 Democracy Date: November 17, 2015.
requirements of the applicable statutes Boulevard, Bethesda, MD 20892, (Telephone Time: 1:00 p.m. to 5:00 p.m.
and regulations. Conference Call). Agenda: To review and evaluate grant
Contact Person: Maria E. Davila-Bloom, applications.
III. Electronic Access Ph.D., Scientific Review Officer, Review Place: National Institutes of Health,
Branch, DEA, NIDDK, National Institutes of Natcher Building, 45 Center Drive, Room
Persons with access to the Internet Health, Room 758, 6707 Democracy
may obtain an electronic version of the 3An.12N, Bethesda, MD 20892, (Telephone
Boulevard, Bethesda, MD 20892–5452, (301) Conference Call).
guidance at either http:// 594–7637, davila-bloomm@ Contact Person: Margaret J. Weidman,
www.regulations.gov or http:// extra.niddk.nih.gov. Ph.D., Scientific Review Officer, Office of
www.fda.gov/TobaccoProducts/ (Catalogue of Federal Domestic Assistance Scientific Review, National Institute of
GuidanceComplianceRegulatory Program Nos. 93.847, Diabetes, General Medical Sciences, National Institutes
Information/default.htm. Endocrinology and Metabolic Research; of Health, 45 Center Drive, Room 3An.12N,
93.848, Digestive Diseases and Nutrition Bethesda, MD 20892, 301–594–3663,
Dated: October 20, 2015.
Research; 93.849, Kidney Diseases, Urology weidmanma@nigms.nih.gov.
Leslie Kux, and Hematology Research, National Institutes Name of Committee: National Institute of
Associate Commissioner for Policy. of Health, HHS) General Medical Sciences Special Emphasis
[FR Doc. 2015–27111 Filed 10–23–15; 8:45 am] Dated: October 20, 2015. Panel; Review of K99 and R01 Grant
BILLING CODE 4164–01–P Applications.
David Clary,
Date: November 17, 2015.
Program Analyst, Office of Federal Advisory Time: 8:00 a.m. to 5:00 p.m.
Committee Policy. Agenda: To review and evaluate grant
DEPARTMENT OF HEALTH AND
[FR Doc. 2015–27061 Filed 10–23–15; 8:45 am] applications.
HUMAN SERVICES Place: Courtyard by Marriott Chevy Chase,
BILLING CODE 4140–01–P
5520 Wisconsin Avenue, Chevy Chase, MD
National Institutes of Health 20815.
DEPARTMENT OF HEALTH AND Contact Person: Lee Warren Slice, Ph.D.,
National Institute of Diabetes and Scientific Review Officer, Office of Scientific
Digestive and Kidney Diseases Notice HUMAN SERVICES Review, National Institute of General Medical
of Closed Meetings Sciences, National Institutes of Health, 45
National Institutes of Health Center Drive, Room 3An.12E, Bethesda, MD
Pursuant to section 10(d) of the 20892, 301–435–0807, slicelw@mail.nih.gov.
Federal Advisory Committee Act, as National Institute of General Medical
Name of Committee: National Institute of
amended (5 U.S.C. App.), notice is Sciences; Notice of Closed Meetings
General Medical Sciences Special Emphasis
hereby given of the following meetings. Pursuant to section 10(d) of the Panel; Support of Competitive Research
The meetings will be closed to the (SCORE) Awards.
Federal Advisory Committee Act, as
public in accordance with the Date: November 18, 2015.
amended (5 U.S.C. App.), notice is
provisions set forth in sections Time: 8:00 a.m. to 6:00 p.m.
hereby given of the following meetings. Agenda: To review and evaluate grant
552b(c)(4) and 552b(c)(6), title 5 U.S.C., The meetings will be closed to the
as amended. The grant applications and applications.
public in accordance with the Place: Embassy Suites at the Chevy Chase
the discussions could disclose
provisions set forth in sections Pavilion, 4300 Military Road NW.,
confidential trade secrets or commercial
552b(c)(4) and 552b(c)(6), title 5 U.S.C., Washington, DC 20015
property such as patentable material, Contact Person: Nina Sidorova, Ph.D.,
as amended. The grant applications and
and personal information concerning Scientific Review Officer, Office of Scientific
the discussions could disclose
individuals associated with the grant Review, National Institute of General Medical
confidential trade secrets or commercial
applications, the disclosure of which Sciences, National Institutes of Health, 45
property such as patentable material, Center Drive, Room 3An.12K, Bethesda, MD
would constitute a clearly unwarranted
and personal information concerning 20892, 301–402–2783, sidorova@
invasion of personal privacy.
individuals associated with the grant nigms.nih.gov.
Name of Committee: National Institute of applications, the disclosure of which (Catalogue of Federal Domestic Assistance
Diabetes and Digestive and Kidney Diseases would constitute a clearly unwarranted Program Nos. 93.375, Minority Biomedical
Special Emphasis Panel; Ancillary R01
invasion of personal privacy. Research Support; 93.821, Cell Biology and
Telephone Review SEP.
Biophysics Research; 93.859, Pharmacology,
Date: November 10, 2015. Name of Committee: National Institute of
Physiology, and Biological Chemistry
Time: 1:00 p.m. to 2:00 p.m. General Medical Sciences Special Emphasis
Panel; Support of NIGMS Program Project Research; 93.862, Genetics and
Agenda: To review and evaluate grant
Grants. Developmental Biology Research; 93.88,
applications.
Minority Access to Research Careers; 93.96,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Place: National Institutes of Health, Two Date: November 16, 2015.
Time: 1:00 p.m. to 5:00 p.m. Special Minority Initiatives, National
Democracy Plaza, 6707 Democracy
Agenda: To review and evaluate grant Institutes of Health, HHS)
Boulevard, Bethesda, MD 20892, (Telephone
Conference Call). applications. Dated: October 20, 2015.
Contact Person: Xiaodu Guo, MD, Ph.D., Place: National Institutes of Health, Melanie J. Gray,
Scientific Review Officer, Review Branch, Natcher Building, 45 Center Drive, Room
Program Analyst, Office of Federal Advisory
DEA, NIDDK, National Institutes of Health, 3An.12N, Bethesda, MD 20892, (Telephone
Committee Policy.
Room 761, 6707 Democracy Boulevard, Conference Call).
Bethesda, MD 20892–5452, (301) 594–4719, Contact Person: Margaret J. Weidman, [FR Doc. 2015–27059 Filed 10–23–15; 8:45 am]
guox@extra.niddk.nih.gov. Ph.D., Scientific Review Officer, Office of BILLING CODE 4140–01–P
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Document Created: 2018-02-27 08:56:23
Document Modified: 2018-02-27 08:56:23
| 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 | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Katherine Collins, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 65229 |
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