80 FR 57531 - National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 185 (September 24, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 185 (September 24, 2015)
| Page Range | 57531-57536 | |
| FR Document | 2015-24219 |
[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)] [Rules and Regulations] [Pages 57531-57536] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24219] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 25 [Docket No. FDA-2013-N-1282] National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: In accordance with the National Environmental Policy Act of 1969 (NEPA) and the Council on Environmental Quality (CEQ) Regulations Implementing NEPA (CEQ regulations), the Food and Drug Administration (FDA or the Agency) is issuing a final rule to revise its NEPA implementing regulations to provide categorical exclusions for certain actions related to substantial equivalence (SE) reports, SE exemption requests, and tobacco product applications, and the rescission (order withdrawing an order) or suspension of orders regarding the marketing of tobacco products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). FDA is also amending its NEPA implementing regulations to include tobacco products, where appropriate, in light of its new authority under the Tobacco Control Act. DATES: This rule is effective October 26, 2015. FOR FURTHER INFORMATION CONTACT: Gerie Voss or Katherine Collins, 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] or [email protected]. Executive Summary Purpose of the Final Rule This final rule 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). FDA is also amending its NEPA implementing regulations to include tobacco products, where appropriate, in light of its new authority under the Tobacco Control Act (Pub. L. 111-31). Legal Authority FDA is issuing this final rule under NEPA and CEQ regulations (42 U.S.C. 4332(2); 40 CFR parts 1500 to 1508) requiring FDA 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. FDA regulations governing its responsibilities under NEPA are codified at part 25 (21 CFR part 25), and CEQ regulations are codified at 40 CFR parts 1500 to 1508. Summary of the Major Provisions This final rule applies to certain classes of tobacco product- related actions including: (1) Issuance of an order finding a tobacco product substantially equivalent under section 910(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 387j(a)(2)(B)); (2) issuance of an order finding a tobacco product not substantially equivalent under section 910(a) of the FD&C Act, denial of a request for an exemption under 21 CFR part 1107 (part 1107) from the requirement of demonstrating substantial equivalence, issuance of an order under section 910(c) of the FD&C Act that a new tobacco product may not be introduced or delivered for introduction into interstate commerce, or issuance of an order under section 911 of the FD&C Act (21 U.S.C. 387k) that a modified risk tobacco product (MRTP) may not be introduced or delivered for introduction into interstate commerce; (3) rescission (order withdrawing an order) or temporary suspension of an order authorizing the marketing of a new tobacco product under section 910 of the FD&C Act; (4) rescission of an order authorizing the marketing of a MRTP under section 911 of the FD&C Act; and (5) rescission of an order granting an exemption request under Sec. 1107.1 (21 CFR 1107.1). This final rule provides that certain classes of actions are categorically excluded from the requirement to prepare an EA or EIS unless extraordinary circumstances are present such that the specific proposed action may have the potential to significantly affect the quality of the human environment. The rule also amends FDA's NEPA implementing regulations to include tobacco products in sections dealing with statements about disclosure regarding certain FDA actions and preparation of an EIS. I. Background and Legal Authority 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). CEQ is responsible for CEQ regulations and for overseeing Federal efforts to comply with NEPA. Both FDA and CEQ have issued regulations governing Agency obligations and responsibilities under NEPA. FDA regulations are codified at part 25 and CEQ regulations are codified at 40 CFR parts 1500 to 1508. CEQ regulations, which are binding on all Federal Agencies, establish [[Page 57532]] procedures for implementing NEPA. Agencies may adopt procedures to supplement CEQ's regulations. In adopting NEPA-implementing procedures, Federal Agencies are directed by CEQ to reduce paperwork (40 CFR 1500.4 and 1500.2(b)) and to reduce delay (40 CFR 1500.5) by using several means, including the use of categorical exclusions. CEQ regulations also state that Agencies shall continue to review their policies and procedures and, in consultation with CEQ, revise them as necessary to ensure full compliance with the purpose and provisions of NEPA (40 CFR 1507.3). FDA regulations state that for major Federal actions that may ``significantly affect the quality of the human environment,'' FDA must prepare an EIS (Sec. 25.22 (21 CFR 25.22); see also 40 CFR 1501.4). The term ``significantly,'' as used in NEPA, requires considerations of both ``context'' (i.e., analyzed in several contexts) and ``intensity'' (i.e., severity of impact) (40 CFR 1508.27(a), (b)). If the action 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 (Sec. 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 (Sec. 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 Sec. 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. If a submitter elects to request a categorical exclusion for a proposed action, a claim of categorical exclusion must be submitted in accordance with Sec. 25.15. Section 25.15 requires that the claim of categorical exclusion include: (1) A statement of compliance with the categorical exclusion criteria and (2) a statement that, to the submitter's knowledge, no extraordinary circumstances exist. In November 2010, CEQ issued a final guidance on categorical exclusions including the process Federal Agencies should use to establish new categorical exclusions. The guidance states that Agencies can establish new categorical exclusions to reduce paperwork and delay where the Agency has developed a record illustrating that the proposed categorical exclusion covers a category of action that, on the basis of past experience, does not normally have the potential to cause significant environmental effects (Ref. 1 at pp. 2 and 16; 40 CFR 1508.4). In addition, when Agencies acquire new responsibilities through legislation or administrative restructuring, they should propose new categorical exclusions after they, or other Agencies, gain sufficient experience with the new activities to make a reasoned determination that any resulting environmental impacts are not significant (Ref. 1 at p. 18). FDA is issuing new categorical exclusions in accordance with NEPA, FDA, and CEQ regulations, and the CEQ November 2010 categorical exclusion guidance. In the Federal Register of January 23, 2014 (79 FR 3742), FDA issued a notice of proposed rulemaking (NPRM) to categorically exclude certain tobacco product application actions from the requirement to conduct an EA or EIS unless extraordinary circumstances are present such that the specific proposed action may have the potential to significantly affect the quality of the human environment. The NPRM also sought to amend FDA's NEPA implementing regulations to include tobacco products. This final rule includes these categorical exclusions and amends FDA's NEPA implementing regulations. The final rule is issued under 42 U.S.C. 4332(2) and 40 CFR 1507.3, which requires FDA 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). II. Overview of the Final Rule FDA considered all of the comments it received regarding the proposed rule and is finalizing it with three changes. We have changed the text of Sec. 25.20(o) in the final rule to clarify that granting a request for an exemption under part 1107 from the requirement of demonstrating substantial equivalence normally requires the preparation of an EA, unless it is subject to a categorical exclusion. Similarly, we have changed the text of Sec. 25.35(b) to clarify that denial of a request for an exemption under part 1107 from the requirement of demonstrating substantial equivalence is categorically excluded and, therefore, normally does not require the preparation of an EA or an EIS. We have also made a technical change by replacing the term ``ordinarily'' with ``normally'' in Sec. Sec. 25.20 and 25.35 to conform with 40 CFR 1508.4. The Agency considers these terms, as used in these regulations, to be synonymous. FDA will continue to evaluate the need for this conforming amendment to other FDA regulations in part 25 as the FDA regulations are updated. In addition, Sec. 25.20(o) in the final rule replaces proposed Sec. 25.20(p) (Issuance of an order finding a tobacco product substantially equivalent under the FD&C Act, unless categorically excluded under Sec. 25.35) andSec. 25.20(p) replaces Sec. 25.20(q) (Issuance of an order authorizing marketing of a new tobacco product under section 910 of the FD&C Act or an order authorizing marketing of a modified risk tobacco product under section 911 of the FD&C Act, unless categorically excluded under Sec. 25.35). The Agency has prepared EAs for many Agency-initiated actions and has reviewed hundreds of EAs for a variety of industry requests for Agency action on foods, drugs, and medical devices for human consumption and use, and foods and drugs given to animals. In accordance with Sec. 25.40(a), these EAs have focused on the potential environmental effects related to the use and disposal from use of FDA- regulated articles. Based on FDA's experience reviewing EAs for actions involving foods, drugs, and medical devices for human consumption and use, and food and drugs given to animals, and its evaluation and knowledge of other relevant environmental science, FDA has determined that certain classes of actions related to tobacco products normally do not cause significant environmental effects and, therefore, should be added to the list of actions that are excluded from the requirement to prepare an EA or an EIS. In addition, FDA has gained sufficient experience from its responsibilities under the Tobacco Control Act to determine that certain actions on tobacco-related applications do not result in significant environmental impacts to the quality of the human environment. Accordingly, FDA is adding several new categorical exclusions for tobacco product-related actions. With this final rule, FDA is adding the following classes of tobacco product-related actions that qualify for categorical exclusions: (1) Issuance of an order finding a tobacco product substantially equivalent to a tobacco [[Page 57533]] product commercially marketed in the United States as of February 15, 2007, under section 910(a)(2)(B) of the FD&C Act; (2) issuance of an order finding a tobacco product not substantially equivalent under section 910(a) of the FD&C Act, denial of a request for an exemption under part 1107 from the requirement of demonstrating substantial equivalence, issuance of an order under section 910(c) of the FD&C Act that a new tobacco product may not be introduced or delivered for introduction into interstate commerce, or issuance of an order under section 911 of the FD&C Act that a MRTP may not be introduced or delivered for introduction into interstate commerce (a MRTP is any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products); (3) rescission (order withdrawing an order) or temporary suspension of an order authorizing the marketing of a new tobacco product under section 910 of the FD&C Act; (4) rescission of an order authorizing the marketing of a MRTP under section 911 of the FD&C Act; and (5) rescission of an order granting an exemption request under Sec. 1107.1. III. Comments on the Proposed Rule FDA received 10 comments on the proposed rule. Comments were received from tobacco product manufacturers, environmental groups, and individuals. To make it easier to identify comments and our responses, the word ``Comment,'' in parentheses, will appear before each comment, and the word ``Response,'' in parentheses, will appear before each response. We have numbered the comments to make it easier to distinguish between comments; the numbers are for organizational purposes only and do not reflect the order in which we received the comments or any value associated with them. We have combined similar comments under one numbered comment. In addition to the comments specific to this rulemaking that we address in the following paragraphs, we received five general comments: (1) One expressing a view that all tobacco products should be prohibited; (2) another providing reasons why FDA should regulate tobacco products and tobacco marketing; (3) one opposing any regulation that decreases FDA authority; (4) one supporting another comment; and (5) one that stated general disagreement with FDA proposing rules for this policy. These comments express broad policy views and do not address specific points related to this rulemaking. Because these general comments fall outside the scope of the proposed rule, we do not address them here. The remaining comments and FDA's responses follow. (Comment 1) Multiple comments addressed the classes of tobacco actions FDA proposed to qualify for categorical exclusions. Several comments did not want FDA to categorically exclude any class of actions from the requirement to prepare an EA or EIS. These comments stated that the tobacco industry has misrepresented facts and relevant information regarding adverse impacts of its tobacco products and cannot be trusted to determine whether extraordinary circumstances are present such that the specific proposed action may have the potential to significantly affect the quality of the human environment. (Response) We disagree with these comments. FDA is categorically excluding those actions that FDA has determined, based on experience, will not significantly affect the quality of the human environment. Additionally, this final rule will require a person submitting a tobacco product application to certify that the application qualifies for a categorical exclusion. FDA may deny the application if the submitter makes a false certification. In addition, under section 1001 of title 18 of the United States Code, anyone who makes a materially false, fictitious, or fraudulent statement to the Government of the United States is subject to criminal penalties. FDA, therefore, will continue to have appropriate oversight of the environmental impacts of tobacco product applications that are the subject of this final rule. (Comment 2) Other comments expressed support for the rule and recommended that FDA add additional categorical exclusions for marketing authorizations for products that are the subject of SE reports under section 910(a)(2)(A) (nonprovisional SE reports) and SE exemption requests under section 905(j)(3) of the FD&C Act (21 U.S.C. 387e(j)(3)). These comments stated that FDA's analysis in support of the proposed rule should apply to these actions as well. (Response) We disagree. As we stated in the proposed rule, FDA expects that any new tobacco product that receives marketing authorization through any of the available premarket pathways will have less--or no more--environmental impact than do tobacco products currently on the market. However, FDA does not yet have data to determine whether these actions, in the aggregate, will significantly impact the environment. Actions on provisional SE reports, by contrast, will relate only to products already on the market. Therefore, FDA is not proposing to add such categorical exclusions at this time. (Comment 3) Comments provided several reasons why they believe categorically excluding nonprovisional SE reports and SE exemption requests from the requirement to develop an EA or EIS for tobacco products will not significantly affect the quality of the human environment. First, comments stated that marketing authorizations for products that are the subject of nonprovisional SE reports and SE exemption requests will not lead to a larger overall tobacco product market or expand tobacco product consumption; and tobacco products found SE or exempt from SE will compete with or replace tobacco products currently on the market. In addition, comments estimated that the number of new tobacco products for which FDA issues SE orders (for nonprovisional SE reports under section 910(a)(2)(A) of the FD&C Act) or grants SE exemptions would be relatively small. Second, comments urged FDA to categorically exclude the granting of SE exemption requests because they believe the foreseeable environmental effects are even less significant for SE exemptions than for nonprovisional SE reports, based upon the more limited circumstances in which a product would be eligible for a request for an SE exemption. Third, comments stated that authorizing categorical exclusions for marketing authorizations for products that are the subject of nonprovisional SE reports and SE exemption requests would be consistent with FDA's regulatory approach to premarket clearances and approvals for other product categories regulated by the Agency. Comments also maintained that the tobacco industry's previous experience with EAs for tobacco product applications demonstrates that these tobacco products are unlikely to significantly affect environment. Fourth, a comment suggested that the extraordinary circumstances provision of the proposed rule supports inclusion of other classes of tobacco actions because it provides a mechanism by which to prevent any SE report or SE exemption request from resulting in the exposure of substances harmful to some biological mechanisms or systems in the environment or cause harm to a protected or endangered species. (Response) We disagree with these comments. CEQ has provided guidance to Federal Agencies for substantiating a new or revised categorical exclusion. In this guidance, CEQ explains that [[Page 57534]] Federal Agencies should propose new categorical exclusions after they, or other Agencies, ``gain sufficient experience with new activities to make a reasoned determination that any resulting environmental impacts are not significant.'' At this time, FDA is not yet able to effectively evaluate whether these classes of actions will lead to a larger overall tobacco product market or expand tobacco product consumption. A finding of SE for products that are the subject of a nonprovisional SE report, while comparing one tobacco product to another for characteristics and public health impact, does not account for the environmental impact of many determinations in the aggregate. FDA will continue to monitor submissions and will consider issuing a new proposed rule if the Agency determines that additional tobacco product actions should be categorically excluded, in the absence of extraordinary circumstances, from further analysis in an EA or EIS. (Comment 4) One comment stated that FDA should revise the examples provided in the preamble of the proposed rule regarding circumstances where a categorical exclusion would not be appropriate for tobacco products. This comment stated that FDA paraphrases two extraordinary circumstances examples provided in the regulations (at Sec. 25.21(a) and (b)) and unnecessarily expands the scope of these provisions. (Response) We disagree with this comment's characterization of FDA's discussion of extraordinary circumstances. FDA's description in the preamble provided circumstances for which EA or EIS preparation may be required for tobacco product applications. The descriptions were not intended to expand the existing regulations on extraordinary circumstances (Sec. 25.21 Extraordinary circumstances) but, rather, to apply them to tobacco product applications. As set forth in Sec. 25.21, FDA will require preparation of at least an EA for an action that would normally be categorically excluded if extraordinary circumstances are present such that the proposed Agency action may have the potential to ``significantly'' affect the quality of the human environment. The ``protected or endangered species'' mentioned in the preamble to the proposed rule will continue to be those determined under the Endangered Species Act or the Convention on International Trade in Endangered Species of Wild Flora and Fauna to be endangered or threatened or wild flora or fauna that are entitled to special protection under some other Federal law, as stipulated at Sec. 25.21(b). As stated in the preamble of the proposed rule, FDA will continue to rely upon consideration of the intensity and context as set out at 40 CFR 1508.27 for determining whether an extraordinary circumstance is present and a proposed action may have the potential to significantly affect the environment (79 FR 3742 at 3746). (Comment 5) Two comments questioned FDA's assertion that tobacco product waste is ``individually and cumulatively trivial'' and asserted that FDA did not review a sufficient number of studies. These comments urged FDA to not finalize the proposed rule based on the environmental impact of tobacco product waste. They noted that the growing of tobacco and manufacturing of cigarettes may result in a variety of pesticides, herbicides, insecticides, fungicides, and rodenticides being deposited into the environment, and 4,000 chemicals may be introduced to the environment via tobacco product waste, thirdhand, and secondhand smoke. One comment stated that the environmental impacts of tobacco product manufacture and disposal are best addressed by having FDA retain the lead role in preparing any necessary EISs or EAs. (Response) FDA disagrees with comments stating that it did not adequately consider the environmental impact of tobacco product waste. FDA reviewed the 2011 Toxics Release Inventory National Analysis to determine that the amount of waste released, recycled, and treated due to the manufacturer of all tobacco products currently on the market is a fraction of the total toxic waste released from and managed by industrial facilities in the United States. The classes of actions that FDA proposed for categorical exclusions do not result in additional tobacco products being marketed because those exclusions represent either the marketing authorization of tobacco products already on the market (provisional SE reports), or the rescission, suspension, or denial of authorization for a new tobacco product. As mentioned in the proposed rule, FDA also reviewed the effect on the environment due to the use (including secondhand and thirdhand smoke) and disposal of tobacco products (including cigarette butts) currently on the market. FDA acknowledged that currently marketed tobacco products contribute to pollution on beaches and streets and affect wildlife and marine and freshwater fish. FDA concluded from its review that the effects of keeping tobacco products on the market are individually and cumulatively trivial compared to the existing environmental effects due to toxic waste released from and managed in industrial facilities in the United States and the existing environmental effects due to the use and disposal from use of the tobacco products in the country (79 FR 3742 at 3745). FDA has carefully considered the information available in order to conclude that these tobacco product actions qualify for categorical exclusion under NEPA. V. Environmental Impact The amendment of FDA's NEPA regulations (part 25) concerns NEPA documentation for certain actions on tobacco product submission. CEQ does not direct Federal Agencies to prepare a NEPA analysis or document before establishing Agency procedures that supplement CEQ regulations for implementing NEPA. Agencies are required to adopt NEPA procedures that establish specific criteria for, and identification of, three classes of actions: (1) Those that require preparation of an EIS; (2) those that require preparation of an EA; (3) and those that are categorically excluded from further NEPA review (40 CFR 1507.3(b)). Categorical exclusions are one part of those Agency procedures; therefore, establishing categorical exclusions does not require preparation of a NEPA analysis or document. Agency NEPA procedures, such as FDA's EPA regulations, assist FDA in the fulfillment of Agency responsibilities under NEPA, but are not FDA's final determination of what level of NEPA analysis is required for a particular proposed action on a tobacco product submission. The requirements for establishing Agency NEPA procedures are set forth at 40 CFR 1505.1 and 1507.3. Furthermore, the Agency has also determined under Sec. 25.30(h) that this rulemaking does not individually or cumulatively have a significant effect on the quality of the human environment. VI. Analysis of Impacts The final regulatory impact analysis is available as Reference 2 in Docket No. FDA-2013-N-1282 (Ref. 2) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm. VII. Paperwork Reduction Act of 1995 This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 is not required. [[Page 57535]] VIII. Federalism FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the final rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. IX. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m. Monday through Friday, and are available electronically at http://www.regulations.gov. 1. Council on Environmental Quality, ``Final Guidance for Federal Departments and Agencies on Establishing, Applying, and Revising Categorical Exclusions Under the National Environmental Policy Act,'' 76 FR 3843, January 21, 2011. 2. Statement of RADM David Ashley, Ph.D. and Hoshing Chang, Ph.D., ``Impact of Tobacco Products on the Environment.'' List of Subjects in 21 CFR Part 25 Environmental impact statements, Foreign relations, Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug, and Cosmetic Act, and authority delegated to the Commissioner of Food and Drugs, 21 CFR part 25 is amended as follows: PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS 0 1. The authority citation for 21 CFR part 25 continues to read as follows: Authority: 21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR, 1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980 Comp., p. 356-360. Sec. 25.15 [Amended] 0 2. Amend Sec. 25.15 as follows: 0 a. In paragraph (a), remove ``or 25.34,'' and add in its place ``25.34, or 25.35,''; 0 b. In paragraph (c), remove ``or 25.34'' and add in its place ``25.34, or 25.35''; and 0 c. In paragraph (d), remove ``or 25.34,'' and add in its place ``25.34, or 25.35,''. 0 3. Amend Sec. 25.20 by revising the introductory text and by adding paragraphs (o) and (p) to read as follows: Sec. 25.20 Actions requiring preparation of an environmental assessment. Any proposed action of a type specified in this section normally requires at least the preparation of an EA, unless it is an action in a specific class that qualifies for exclusion under Sec. Sec. 25.30, 25.31, 25.32, 25.33, 25.34, or 25.35: * * * * * (o) Issuance of an order finding a tobacco product substantially equivalent under the Federal Food, Drug, and Cosmetic Act, or granting of a request for an exemption under 21 CFR part 1107 from the requirement of demonstrating substantial equivalence, unless categorically excluded under Sec. 25.35. (p) Issuance of an order authorizing marketing of a new tobacco product under section 910 of the Federal Food, Drug, and Cosmetic Act or an order authorizing marketing of a modified risk tobacco product under section 911 of the Federal Food, Drug, and Cosmetic Act, unless categorically excluded under Sec. 25.35. Sec. 25.30 [Amended] 0 4. Amend the introductory text of Sec. 25.30 by removing ``25.34'' and adding in its place ``25.35''. 0 5. Add Sec. 25.35 to subpart C to read as follows: Sec. 25.35 Tobacco product applications. The classes of actions listed in this section are categorically excluded and, therefore, normally do not require the preparation of an EA or an EIS: (a) Issuance of an order finding a tobacco product substantially equivalent under section 910(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act; (b) Issuance of an order finding a tobacco product not substantially equivalent under section 910(a) of the Federal Food, Drug, and Cosmetic Act, denial of a request for an exemption under 21 CFR part 1107 from the requirement of demonstrating substantial equivalence, issuance of an order under section 910(c) of the Federal Food, Drug, and Cosmetic Act that a new tobacco product may not be introduced or delivered for introduction into interstate commerce, or issuance of an order under section 911 of the Federal Food, Drug, and Cosmetic Act that a modified risk tobacco product may not be introduced or delivered for introduction into interstate commerce; (c) Rescission or temporary suspension of an order authorizing the marketing of a new tobacco product under section 910 of the Federal Food, Drug, and Cosmetic Act; (d) Rescission of an order authorizing the marketing of a modified risk tobacco product under section 911 of the Federal Food, Drug, and Cosmetic Act; and (e) Rescission of an order granting an exemption request under Sec. 1107.1 of this chapter. Sec. 25.40 [Amended] 0 6. Amend Sec. 25.40 by removing from paragraph (a) ``or Sec. 25.34'' and adding in its place, ``Sec. 25.34, or Sec. 25.35.'' 0 7. Amend Sec. 25.50 by revising the first, third, fourth, and fifth sentences of paragraph (b) to read as follows: Sec. 25.50 General information. * * * * * (b) Many FDA actions involving investigations, review, and approval or market authorization of applications, and premarket notifications for human drugs, animal drugs, biologic products, devices, and tobacco products are protected from disclosure under the Trade Secret Act, 18 U.S.C. 1905, and section 301(j) of the Federal Food, Drug, and Cosmetic Act. * * * Even the existence of applications for human drugs, animal drugs, biologic products, devices, and tobacco products is protected from disclosure under these regulations. Therefore, unless the existence of applications for human drugs, animal drugs, biologic products, tobacco products, or premarket notification for devices has been made publicly available, the release of the environmental document before approval or authorization of human drugs, animal drugs, biologic products, devices and tobacco products is inconsistent with statutory requirements imposed on FDA. Appropriate environmental documents, comments, and responses will be included in the administrative record to the extent allowed by applicable laws. 0 8. Amend Sec. 25.52 by revising the first sentence of paragraph (a) and paragraphs (b) and (c) to read as follows: Sec. 25.52 Environmental impact statements. (a) If FDA determines that an EIS is necessary for an action involving investigations, approvals, or market authorizations for drugs, animal drugs, biologic products, devices, or tobacco products, an EIS will be prepared but will become available only at the time [[Page 57536]] of the approval or market authorization of the product. * * * (b) Comments on the EIS may be submitted after the approval or market authorization of the drug, animal drug, biologic product, device, or tobacco product. Those comments can form the basis for the Agency to consider beginning an action to withdraw the approval or market authorization of applications for a drug, animal drug, biologic product, or tobacco product, or to withdraw premarket notifications or premarket approval applications for devices. (c) In those cases where the existence of applications and premarket notifications for drugs, animal drugs, biologic products, devices, or tobacco products has already been disclosed before the Agency approves the action, the Agency will ensure appropriate public involvement consistent with 40 CFR 1506.6 and part 1503 in preparing and implementing the NEPA procedures related to preparing EISs while following its own disclosure requirements including those listed in part 20 and Sec. Sec. 312.130(b), 314.430(d), 514.11(d), 514.12(b), 601.51(d), 807.95(e), 812.38(b), and 814.9(d) of this chapter. * * * * * Dated: September 16, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-24219 Filed 9-23-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Rules and Regulations 57531
or procedural or that do not 1969 (NEPA) and the Council on actions including: (1) Issuance of an
substantially change the effect of the Environmental Quality (CEQ) order finding a tobacco product
regulations being amended.44 The Regulations Implementing NEPA (CEQ substantially equivalent under section
actions taken herein fall within this regulations), the Food and Drug 910(a)(2)(B) of the Federal Food, Drug,
categorical exclusion in the Administration (FDA or the Agency) is and Cosmetic Act (the FD&C Act) (21
Commission’s regulations. issuing a final rule to revise its NEPA U.S.C. 387j(a)(2)(B)); (2) issuance of an
implementing regulations to provide order finding a tobacco product not
VI. Document Availability
categorical exclusions for certain actions substantially equivalent under section
40. In addition to publishing the full related to substantial equivalence (SE) 910(a) of the FD&C Act, denial of a
text of this document in the Federal reports, SE exemption requests, and request for an exemption under 21 CFR
Register, the Commission provides all tobacco product applications, and the part 1107 (part 1107) from the
interested persons an opportunity to rescission (order withdrawing an order) requirement of demonstrating
view and/or print the contents of this or suspension of orders regarding the substantial equivalence, issuance of an
document via the Internet through the marketing of tobacco products under the order under section 910(c) of the FD&C
Commission’s home page (http:// Family Smoking Prevention and Act that a new tobacco product may not
www.ferc.gov) and in the Commission’s Tobacco Control Act (Tobacco Control be introduced or delivered for
Public Reference Room during normal Act). FDA is also amending its NEPA introduction into interstate commerce,
business hours (8:30 a.m. to 5:00 p.m. implementing regulations to include or issuance of an order under section
Eastern time) at 888 First Street NE., tobacco products, where appropriate, in 911 of the FD&C Act (21 U.S.C. 387k)
Room 2A, Washington, DC 20426. light of its new authority under the that a modified risk tobacco product
41. From the Commission’s home Tobacco Control Act. (MRTP) may not be introduced or
page on the internet, this information is delivered for introduction into interstate
DATES: This rule is effective October 26,
available on eLibrary. The full text of commerce; (3) rescission (order
this document is available on eLibrary 2015.
withdrawing an order) or temporary
in PDF and Microsoft Word format for FOR FURTHER INFORMATION CONTACT:
suspension of an order authorizing the
viewing, printing, and/or downloading. Gerie Voss or Katherine Collins, Center
marketing of a new tobacco product
To access this document in eLibrary, for Tobacco Products, Food and Drug
under section 910 of the FD&C Act; (4)
type the docket number of this Administration, Document Control
rescission of an order authorizing the
document excluding the last three digits Center, Bldg. 71, Rm. G335, 10903 New
marketing of a MRTP under section 911
in the docket number field. Hampshire Ave., Silver Spring, MD
of the FD&C Act; and (5) rescission of
42. User assistance is available for 20993–0002, 877–287–1373; gerie.voss@
an order granting an exemption request
eLibrary and the Commission’s Web site fda.hhs.gov or katherine.collins@ under § 1107.1 (21 CFR 1107.1).
during normal business hours from the fda.hhs.gov. This final rule provides that certain
Commission’s online support at 202– Executive Summary classes of actions are categorically
502–6652 (toll free at 1–866–208–3676) excluded from the requirement to
or email at ferconlinesupport@ferc.gov, Purpose of the Final Rule prepare an EA or EIS unless
or the public reference room at (202) This final rule will allow certain extraordinary circumstances are present
502–8371, TTY (202) 502–8659. Email classes of actions on tobacco product such that the specific proposed action
the Commission’s public reference room marketing applications to be excluded may have the potential to significantly
at public.referenceroom@ferc.gov. from the requirements to prepare an affect the quality of the human
By the Commission. environmental assessment (EA) or an environment. The rule also amends
Issued: September 17, 2015. environmental impact statement (EIS). FDA’s NEPA implementing regulations
Nathaniel J. Davis, Sr., FDA is also amending its NEPA to include tobacco products in sections
Deputy Secretary. implementing regulations to include dealing with statements about
[FR Doc. 2015–24280 Filed 9–23–15; 8:45 am]
tobacco products, where appropriate, in disclosure regarding certain FDA
light of its new authority under the actions and preparation of an EIS.
BILLING CODE 6717–01–P
Tobacco Control Act (Pub. L. 111–31). I. Background and Legal Authority
Legal Authority NEPA and CEQ regulations require
DEPARTMENT OF HEALTH AND FDA is issuing this final rule under each Federal Agency to assess, as an
HUMAN SERVICES NEPA and CEQ regulations (42 U.S.C. integral part of its decisionmaking
4332(2); 40 CFR parts 1500 to 1508) process, the environmental impacts of
Food and Drug Administration any proposed Federal action to ascertain
requiring FDA to assess, as an integral
part of its decisionmaking process, the the environmental consequences of that
21 CFR Part 25
environmental impacts of any proposed action on the quality of the human
[Docket No. FDA–2013–N–1282] Federal action to ascertain the environment and to ensure that the
environmental consequences of that interested and affected public is
National Environmental Policy Act; action on the quality of the human appropriately informed (42 U.S.C.
Environmental Assessments for environment and to ensure that the 4332(2); 40 CFR 1506.6). CEQ is
Tobacco Products; Categorical interested and affected public is responsible for CEQ regulations and for
Exclusions appropriately informed. FDA overseeing Federal efforts to comply
AGENCY: Food and Drug Administration, regulations governing its responsibilities with NEPA. Both FDA and CEQ have
HHS. under NEPA are codified at part 25 (21 issued regulations governing Agency
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ACTION: Final rule. CFR part 25), and CEQ regulations are obligations and responsibilities under
codified at 40 CFR parts 1500 to 1508. NEPA. FDA regulations are codified at
SUMMARY: In accordance with the part 25 and CEQ regulations are codified
National Environmental Policy Act of Summary of the Major Provisions at 40 CFR parts 1500 to 1508.
This final rule applies to certain CEQ regulations, which are binding
44 18 CFR 380.4(a)(2)(ii). classes of tobacco product-related on all Federal Agencies, establish
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![Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Rules and Regulations 57535
VIII. Federalism ■ c. In paragraph (d), remove ‘‘or may not be introduced or delivered for
25.34,’’ and add in its place ‘‘25.34, or introduction into interstate commerce;
FDA has analyzed this final rule in
25.35,’’. (c) Rescission or temporary
accordance with the principles set forth
■ 3. Amend § 25.20 by revising the suspension of an order authorizing the
in Executive Order 13132. FDA has
introductory text and by adding marketing of a new tobacco product
determined that the final rule does not
paragraphs (o) and (p) to read as under section 910 of the Federal Food,
contain policies that have substantial
follows: Drug, and Cosmetic Act;
direct effects on the States, on the
(d) Rescission of an order authorizing
relationship between the National § 25.20 Actions requiring preparation of an the marketing of a modified risk tobacco
Government and the States, or on the environmental assessment.
product under section 911 of the
distribution of power and Any proposed action of a type Federal Food, Drug, and Cosmetic Act;
responsibilities among the various specified in this section normally and
levels of government. Accordingly, the requires at least the preparation of an (e) Rescission of an order granting an
Agency has concluded that the rule does EA, unless it is an action in a specific exemption request under § 1107.1 of
not contain policies that have class that qualifies for exclusion under this chapter.
federalism implications as defined in §§ 25.30, 25.31, 25.32, 25.33, 25.34, or
the Executive order and, consequently, 25.35: § 25.40 [Amended]
a federalism summary impact statement * * * * * ■ 6. Amend § 25.40 by removing from
is not required. (o) Issuance of an order finding a paragraph (a) ‘‘or § 25.34’’ and adding in
IX. References tobacco product substantially equivalent its place, ‘‘§ 25.34, or § 25.35.’’
under the Federal Food, Drug, and
The following references have been Cosmetic Act, or granting of a request ■ 7. Amend § 25.50 by revising the first,
placed on display in the Division of for an exemption under 21 CFR part third, fourth, and fifth sentences of
Dockets Management (see ADDRESSES) 1107 from the requirement of paragraph (b) to read as follows:
and may be seen by interested persons demonstrating substantial equivalence, § 25.50 General information.
between 9 a.m. and 4 p.m. Monday unless categorically excluded under
through Friday, and are available * * * * *
§ 25.35.
electronically at http:// (p) Issuance of an order authorizing (b) Many FDA actions involving
www.regulations.gov. marketing of a new tobacco product investigations, review, and approval or
under section 910 of the Federal Food, market authorization of applications,
1. Council on Environmental Quality, ‘‘Final
Drug, and Cosmetic Act or an order and premarket notifications for human
Guidance for Federal Departments and drugs, animal drugs, biologic products,
Agencies on Establishing, Applying, and authorizing marketing of a modified risk
tobacco product under section 911 of devices, and tobacco products are
Revising Categorical Exclusions Under protected from disclosure under the
the National Environmental Policy Act,’’ the Federal Food, Drug, and Cosmetic
Act, unless categorically excluded Trade Secret Act, 18 U.S.C. 1905, and
76 FR 3843, January 21, 2011.
2. Statement of RADM David Ashley, Ph.D. under § 25.35. section 301(j) of the Federal Food, Drug,
and Hoshing Chang, Ph.D., ‘‘Impact of and Cosmetic Act. * * * Even the
Tobacco Products on the Environment.’’ § 25.30 [Amended] existence of applications for human
■ 4. Amend the introductory text of drugs, animal drugs, biologic products,
List of Subjects in 21 CFR Part 25 devices, and tobacco products is
§ 25.30 by removing ‘‘25.34’’ and adding
Environmental impact statements, in its place ‘‘25.35’’. protected from disclosure under these
Foreign relations, Reporting and regulations. Therefore, unless the
■ 5. Add § 25.35 to subpart C to read as
recordkeeping requirements. existence of applications for human
follows:
Therefore, under the Federal Food, drugs, animal drugs, biologic products,
Drug, and Cosmetic Act, and authority § 25.35 Tobacco product applications. tobacco products, or premarket
delegated to the Commissioner of Food The classes of actions listed in this notification for devices has been made
and Drugs, 21 CFR part 25 is amended section are categorically excluded and, publicly available, the release of the
as follows: therefore, normally do not require the environmental document before
preparation of an EA or an EIS: approval or authorization of human
PART 25—ENVIRONMENTAL IMPACT (a) Issuance of an order finding a drugs, animal drugs, biologic products,
CONSIDERATIONS tobacco product substantially equivalent devices and tobacco products is
under section 910(a)(2)(B) of the Federal inconsistent with statutory requirements
■ 1. The authority citation for 21 CFR Food, Drug, and Cosmetic Act; imposed on FDA. Appropriate
part 25 continues to read as follows: (b) Issuance of an order finding a environmental documents, comments,
Authority: 21 U.S.C. 321–393; 42 U.S.C. tobacco product not substantially and responses will be included in the
262, 263b–264; 42 U.S.C. 4321, 4332; 40 CFR equivalent under section 910(a) of the administrative record to the extent
parts 1500–1508; E.O. 11514, 35 FR 4247, 3 Federal Food, Drug, and Cosmetic Act, allowed by applicable laws.
CFR, 1971 Comp., p. 531–533 as amended by denial of a request for an exemption ■ 8. Amend § 25.52 by revising the first
E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp., under 21 CFR part 1107 from the sentence of paragraph (a) and
p. 123–124 and E.O. 12114, 44 FR 1957, 3 requirement of demonstrating paragraphs (b) and (c) to read as follows:
CFR, 1980 Comp., p. 356–360. substantial equivalence, issuance of an
order under section 910(c) of the § 25.52 Environmental impact statements.
§ 25.15 [Amended]
Federal Food, Drug, and Cosmetic Act (a) If FDA determines that an EIS is
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■ 2. Amend § 25.15 as follows: that a new tobacco product may not be necessary for an action involving
■ a. In paragraph (a), remove ‘‘or 25.34,’’ introduced or delivered for introduction investigations, approvals, or market
and add in its place ‘‘25.34, or 25.35,’’; into interstate commerce, or issuance of authorizations for drugs, animal drugs,
■ b. In paragraph (c), remove ‘‘or 25.34’’ an order under section 911 of the biologic products, devices, or tobacco
and add in its place ‘‘25.34, or 25.35’’; Federal Food, Drug, and Cosmetic Act products, an EIS will be prepared but
and that a modified risk tobacco product will become available only at the time
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![57536 Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Rules and Regulations
of the approval or market authorization bridge decking. This deviation allows a and from 7 a.m. to 10 a.m. and from 3:30
of the product. * * * single leaf opening with a one hour p.m. to 7 p.m. from September 1 to
(b) Comments on the EIS may be advance notice during the day, and April 30. The draw need open only on
submitted after the approval or market remains in the closed-to-navigation the hour and half hour from 12:30 p.m.
authorization of the drug, animal drug, position at night. to 3:30 p.m. and from 6 p.m. to 6:30
biologic product, device, or tobacco DATES: This deviation is effective from p.m.
product. Those comments can form the 7 a.m. on October 3, 2015 to 7 a.m. on
basis for the Agency to consider The deviation period is from 7 a.m. on
October 26, 2015.
beginning an action to withdraw the October 3, 2015 until 7 p.m. on October
ADDRESSES: The docket for this
approval or market authorization of 3, 2015 (south single leaf opening if a
deviation, [USCG–2015–0888] is one hour notice is given); from 7 p.m.
applications for a drug, animal drug, available at http://www.regulations.gov.
biologic product, or tobacco product, or on October 3, 2015 until 7 a.m. on
Type the docket number in the
to withdraw premarket notifications or October 4, 2015 (remain in the closed-
‘‘SEARCH’’ box and click ‘‘SEARCH.’’
premarket approval applications for Click on Open Docket Folder on the line to-navigation position); from 7 a.m. on
devices. associated with this deviation. You may October 4, 2015 until 7 p.m. on October
(c) In those cases where the existence also visit the Docket Management 4, 2015 (south single leaf opening if a
of applications and premarket Facility in Room W12–140 on the one hour notice is given); from 7 p.m.
notifications for drugs, animal drugs, ground floor of the Department of on October 4, 2015 until 7 a.m. on
biologic products, devices, or tobacco Transportation West Building, 1200 October 5, 2015 (remain in the closed-
products has already been disclosed New Jersey Avenue SE., Washington, to-navigation position); from 7 a.m. on
before the Agency approves the action, DC 20590, between 9 a.m. and 5 p.m., October 24, 2015 until 7 p.m. on
the Agency will ensure appropriate Monday through Friday, except Federal October 24, 2015 (south single leaf
public involvement consistent with 40 holidays. opening if a one hour notice is given);
CFR 1506.6 and part 1503 in preparing from 7 p.m. on October 24, 2015 until
FOR FURTHER INFORMATION CONTACT: If
and implementing the NEPA procedures 7 a.m. on October 25, 2015 (remain in
you have questions on this temporary
related to preparing EISs while the closed-to-navigation position); from
deviation, call or email Mr. Steven
following its own disclosure 7 a.m. on October 25, 2015 until 7 p.m.
Fischer, Bridge Administrator,
requirements including those listed in
Thirteenth Coast Guard District; on October 25, 2015 (south single leaf
part 20 and §§ 312.130(b), 314.430(d),
telephone 206–220–7282, email d13-pf- opening if a one hour notice is given);
514.11(d), 514.12(b), 601.51(d),
d13bridges@uscg.mil. from 7 p.m. on October 25, 2015 until
807.95(e), 812.38(b), and 814.9(d) of this
chapter. SUPPLEMENTARY INFORMATION: 7 a.m. on October 26, 2015 (remain in
Washington Department of the closed-to-navigation position).
* * * * * Transportation has requested a Waterway usage on the Lake
Dated: September 16, 2015. temporary deviation from the operating Washington Ship Canal ranges from
Leslie Kux, schedule for the Montlake Bridge across commercial tug and barge to small
Associate Commissioner for Policy. the Lake Washington Ship Canal, at
pleasure craft. Vessels able to pass
[FR Doc. 2015–24219 Filed 9–23–15; 8:45 am] mile 5.2, at Seattle, WA. The deviation
through the bridge in the closed-to-
is necessary to accommodate work
BILLING CODE 4164–01–P navigation position may do so at
crews to conduct timely bridge deck
repairs. anytime. The bridge will be able to open
The Montlake Bridge in the closed for emergency vessels in route to a call
DEPARTMENT OF HOMELAND when an hour notice is given to the
position provides 30 feet of vertical
SECURITY bridge operator, and a single leaf
clearance throughout the navigation
Coast Guard channel, and 46 feet of vertical opening will be provided. The Lake
clearance throughout the center 60 feet Washington Ship Canal has no
33 CFR Part 117 of the bridge; vertical clearance immediate alternate route for vessels to
references to the Mean Water Level of pass. The Coast Guard will also inform
[Docket No. USCG–2015–0888] Lake Washington. When half the span is the users of the waterways through our
open, single leaf, 46 feet of vertical Local and Broadcast Notices to Mariners
Drawbridge Operation Regulation;
clearance will be reduced throughout of the change in operating schedule for
Lake Washington Ship Canal, Seattle,
the center to 30 feet of the bridge. the bridge so that vessels can arrange
WA To facilitate this event, the south half their transits to minimize any impact
AGENCY: Coast Guard, DHS. of the bridge span, or single leaf, will caused by the temporary deviation.
ACTION:Notice of deviation from open with at least a one hour advance
notice provided to the bridge operator In accordance with 33 CFR 117.35(e),
drawbridge regulation. the drawbridge must return to its regular
from 7 a.m. to 7 p.m. From 7 p.m. to 7
SUMMARY: The Coast Guard has issued a a.m., the Montlake Bridge span will operating schedule immediately at the
temporary deviation from the operating remain in the closed-to-navigation end of the designated time period. This
schedule that governs the Montlake position, or full closure. deviation from the operating regulations
Bridge across the Lake Washington Ship The normal operating schedule for the is authorized under 33 CFR 117.35.
Canal, mile 5.2, at Seattle, WA. The Montlake Bridge operates in accordance Dated: September 18, 2015.
Montlake Bridge is a double leaf bascule with 33 CFR 117.1051(e) which requires
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Steven M. Fischer,
bridge. The deviation is necessary to the bridge to open on signal, except that
allow the bridge to operate in single leaf the bridge need not open for vessels less Bridge Administrator, Thirteenth Coast Guard
District.
mode during day light hours, and a full than 1,000 gross tons between 7 a.m.
closure (both bascule leafs in the closed- and 9 a.m. and 3:30 p.m. and 6:30 p.m. [FR Doc. 2015–24289 Filed 9–23–15; 8:45 am]
to-navigation position) during night Monday through Friday, except Federal BILLING CODE 9110–04–P
time hours while work crews replace Holidays from April 30 to September 1,
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Document Created: 2018-02-26 10:18:22
Document Modified: 2018-02-26 10:18:22
| 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 | Final rule. | |
| Dates | This rule is effective October 26, 2015. | |
| Contact | Gerie Voss or Katherine Collins, 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] or [email protected] | |
| FR Citation | 80 FR 57531 | |
| CFR Associated | Environmental Impact Statements; Foreign Relations and Reporting and Recordkeeping Requirements |
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