74737 Federal Register / Vol. 80, No. 229 / Monday, November 30, 2015 / Proposed Rules 
feet above the surface within a 6.0-mile 
radius of Clinton Municipal Airport, Clinton, AR, to accommodate new standard instrument approach procedures. Controlled airspace is needed for the safety and management of IFR operations at the airport. 
Class E airspace areas are published 
in Paragraph 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order. 
Regulatory Notices and Analyses 
The FAA has determined that this 
proposed regulation only involves an 
established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a ‘‘significant regulatory action’’ under Executive Order 12866; (2) is not a ‘‘significant rule’’ under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. 
Environmental Review 
This proposal will be subject to an 
environmental analysis in accordance 
with FAA Order 1050.1F, ‘‘Environmental Impacts: Policies and Procedures’’ prior to any FAA final regulatory action. 
List of Subjects in 14 CFR Part 71 
Airspace, Incorporation by reference, 
Navigation (Air). The Proposed Amendment 
In consideration of the foregoing, the 
Federal Aviation Administration 
proposes to amend 14 CFR Part 71 as follows: 
PART 71—DESIGNATION OF CLASS A, 
B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 
■1. The authority citation for Part 71 
continues to read as follows: 
Authority: 49 U.S.C. 106(f), 106(g); 40103, 
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 
1959–1963 Comp., p. 389. § 71.1 [Amended] 
■2. The incorporation by reference in 
14 CFR 71.1 of FAA Order 7400.9Z, 
Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015, is amended as follows: 
Paragraph 6005 Class E Airspace Areas 
Extending Upward from 700 feet or More Above the Surface of the Earth. 
* * * * * 
ASW LA E5 Clinton, LA [New] 
Clinton Municipal Airport, LA 
(Lat. 35°35′52″ N., long. 092°27′06″ W.) 
That airspace extending upward from 700 
feet above the surface within a 6.0-mile 
radius of Clinton Municipal Airport. 
Issued in Fort Worth, TX, on November 18, 
2015. 
Robert W. Beck, Manager, Operations Support Group, ATO 
Central Service Center. 
[FR Doc. 2015–30188 Filed 11–27–15; 8:45 am] 
BILLING CODE 4910–13–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Parts 201, 801, and 1100 
[Docket No. FDA–2015–N–2002] 
RIN 0910–AH19 
Clarification of When Products Made 
or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘‘Intended Uses’’; Reopening of the Comment Period 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Notice of proposed rulemaking; 
reopening of the comment period. 
SUMMARY : The Food and Drug 
Administration (FDA) is reopening the comment period for the notice of proposed rulemaking (NPRM) that appeared in the Federal Register of September 25, 2015. In the NPRM, FDA requested comments on the proposed regulation that describes the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. DATES : The comment period for the 
proposed rule published on September 
25, 2015 (80 FR 57756) is extended. Submit either electronic or written comments by December 30, 2015. 
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 
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– 2015–N–2002 for this rulemaking. 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 
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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. 
FOR FURTHER INFORMATION CONTACT : 
Bryant Godfrey or Darin Achilles, Office of Regulations, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993–0002, 877–287–1373, CTPRegulations@
fda.hhs.gov. 
SUPPLEMENTARY INFORMATION : In the 
Federal Register of September 25, 2015 (80 FR 57756), FDA proposed a regulation that describes the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the FD&C Act. Interested persons were originally given until November 24, 2015, to comment on the NPRM. 
The Agency has received a request for 
a 45-day extension of the comment period for the NPRM. The request conveyed concern that the current 60- day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the NPRM. 
FDA has considered the request and 
is reopening the comment period for the NPRM for 30 days, until December 30, 2015. The Agency believes that reopening the comment period for an additional 30 days allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues. 
Dated: November 23, 2015. 
Leslie Kux, 
Associate Commissioner for Policy. 
[FR Doc. 2015–30271 Filed 11–27–15; 8:45 am] 
BILLING CODE 4164–01–P 
DEPARTMENT OF HOUSING AND 
URBAN DEVELOPMENT 
24 CFR Part 60 
[Docket No FR–5888–P–02] 
Federal Policy for the Protection of 
Human Subjects, Extension of Public Comment Period 
AGENCY : Office of the General Counsel, 
HUD. 
ACTION : Extension of public comment 
period. 
SUMMARY : Through this notice, HUD is 
extending the public comment period on its proposed rule pertaining to Federal Policy for the Protection of Human Subjects, published in the Federal Register on October 1, 2015. 
DATES : Comment Due Date: The 
comment due date of December 7, 2015, for the proposed rule published on October 1, 2015, at 80 FR 59092, is extended to January 6, 2016. 
ADDRESSES : You may submit comments, 
identified by docket ID number HHS– OPHS–2015–0008, by one of the following methods: 
•Federal eRulemaking Portal: http:// 
www.regulations.gov. Enter the above 
docket ID number in the ‘‘Enter Keyword or ID’’ field and click on ‘‘Search.’’ On the next Web page, click on ‘‘Submit a Comment’’ action and follow the instructions. 
•Mail/Hand delivery/Courier [For 
paper, disk, or CD–ROM submissions] to: Jerry Menikoff, M.D., J.D., OHRP, 
1101 Wootton Parkway, Suite 200, Rockville, MD 20852. 
Comments received, including any 
personal information, will be posted without change to www.regulations.gov. FOR FURTHER INFORMATION CONTACT : 
Barry L. Steffen, Policy Development 
Division, Office of Policy Development and Research, Department of Housing and Urban Development, 451 7th Street SW., Room 8114, Washington, DC 20410–8000, telephone 202–402–5926. (This is not a toll-free number.) Persons with hearing- or speech-impairments may access this number through TTY number by calling the Federal Relay Service number at 800–877–8339 (this is a toll-free number). 
SUPPLEMENTARY INFORMATION : 
I. Background 
On October 1, 2015, at 80 FR 59092, 
HUD published a proposed rule in the Federal Register on Federal Policy for the Protection of Human Subjects. HUD’s proposed rule adopted the policy on the protection of human subjects set forth in a proposed rule issued by the Department of Health and Human Services and 15 other Federal Departments and Agencies and published on September 8, 2015, at 80 FR 53933. Through the September 8, 2015, and October 1, 2015, rules, the Federal Departments and Agencies proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 199, and sought comment on the proposed revisions through December 7, 2015. 
Since the proposed rules were 
published in September and October, respectively, requests have been made to extend the public comment period to allow time to more thoroughly review the proposed revisions offered for comment by the Federal Departments and Agencies. The Department of Health and Human Services and the 15 other Federal Department Agencies have extended the time to submit public comments on the September 8, 2015, proposed rule to January 6, 2016, and HUD extends its public comment period for its October 1, 2015, proposed rule to this same date—January 6, 2016. 
Dated: November 24, 2015. 
Camille E. Acevedo, 
Associate General Counsel for Legislation and 
Regulations. 
[FR Doc. 2015–30317 Filed 11–27–15; 8:45 am] 
BILLING CODE 4210–67–P 
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