Establishment of a Public Docket for Administrative Detention Under the Food and Drug Administration Safety and Innovation Act, 21085-21086 [2013-08120]

Download as PDF Federal Register / Vol. 78, No. 68 / Tuesday, April 9, 2013 / Proposed Rules rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This proposed regulation is within the scope of that authority as it would amend Class D and Class E airspace at Oceana NAS (Apollo Soucek Field), VA. This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1E, ‘‘Environmental Impacts: Policies and Procedures’’ prior to any FAA final regulatory action. Lists 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 CLASS 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(g); 40103, 40113, 40120; E.O. 10854, 24 FR9565, 3 CFR, 1959– 1963 Comp., p. 389. § 71.1 [Amended] 2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.9W, Airspace Designations and Reporting Points, signed August 8, 2012, effective September 15, 2012, is amended as follows: ■ * * * Paragraph 6004 Class E airspace designated as an extension to a Class D surface area. * * * * * AEA VA E4 Oceana NAS, VA [Amended] Oceana NAS (Apollo Soucek Field) (lat. 36°49′22″ N., long. 76°01′55″ W.) Navy Oceana TACAN (lat. 36°49′27″ N., long. 76°02′13″ W.) NALF Fentress, VA (lat. 36°41′43″ N., long. 76°08′08″ W.) That airspace extending upward from the surface within 1.8 miles each side of the Navy Oceana TACAN 213° radial extending from the 4.3-mile radius of Oceana NAS (Apollo Soucek Field) to 9.3 miles southwest of the TACAN and within a 2.7-mile radius of NALF Fentress. This Class E airspace area is effective during specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory. Issued in College Park, Georgia, on March 29, 2013. Barry A. Knight, Manager, Operations Support Manager, Eastern Service Center, Air Traffic Organization. [FR Doc. 2013–08210 Filed 4–8–13; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Class D airspace. * tkelley on DSK3SPTVN1PROD with PROPOSALS Paragraph 5000 Navy Oceana TACAN (lat. 36°49′27″ N., long. 76°02′13″ W) NALF Fentress, VA (lat. 36°41′43″ N., long. 76°08′08″ W.) That airspace extending upward from the surface within a 4.3-mile radius of Oceana NAS (Apollo Soucek Field), and within 1.8 miles each side of the Navy Oceana TACAN 213° radial extending from the 4.3-mile radius of Oceana NAS (Apollo Soucek Field) to 9.3 miles southwest of the TACAN and within a 2.7-mile radius of NALF Fentress. This Class E airspace area is effective during specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory. * AEA VA D Oceana NAS, VA [Amended] Oceana NAS (Apollo Soucek Field), VA (lat. 36°49′22″ N., long. 76°01′55″ W.) That airspace extending upward from the surface to and including 2,500 feet MSL within a 4.3-mile radius of Oceana NAS (Apollo Soucek Field). This Class D airspace area is effective during specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory. Food and Drug Administration Paragraph 6002 Class E airspace designated as surface areas. HHS. * * * * * AEA VA E2 Oceana NAS, VA [New] Oceana NAS (Apollo Soucek Field), VA (lat. 36°49′22″ N., long. 76°01′55″ W.) VerDate Mar<15>2010 16:18 Apr 08, 2013 Jkt 229001 21 CFR Chapter I [Docket No. FDA–2013–N–0365] Establishment of a Public Docket for Administrative Detention Under the Food and Drug Administration Safety and Innovation Act AGENCY: Food and Drug Administration, Establishment of docket; request for comments. ACTION: SUMMARY: The Food and Drug Administration (FDA) is announcing the establishment of a public docket for PO 00000 Frm 00014 Fmt 4702 Sfmt 4702 21085 comments pertaining to the implementation of its administrative detention authority with respect to drugs under the Food and Drug Administration Safety and Innovation Act (FDASIA). This document is intended to solicit input from all relevant stakeholders before FDA issues regulations to implement its administrative detention authority with respect to drugs and to announce that such information submitted to FDA is available to all interested persons in a timely fashion. DATES: Submit electronic or written comments by May 9, 2013. ADDRESSES: Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Charlotte Hinkle, Office of Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4345, Silver Spring, MD 20993– 0002, 301–796–5300, FDASIA ImplementationORA@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background On July 9, 2012, President Obama signed FDASIA (Pub. L. 112–144) into law. Section 709 of FDASIA amends section 304(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 334(g)) to provide FDA administrative detention authority with respect to drugs. Section 304(g) of the FD&C Act, as amended by FDASIA, provides FDA the same authority to detain drugs that section 304(g) had already provided FDA with respect to devices and tobacco products. Section 709 of FDASIA requires the Secretary to ‘‘consult with stakeholders, including manufacturers of drugs’’ before issuing implementing regulations. Section 709 also provides that FDA must issue a final rule to implement its administrative detention authority with respect to drugs before the amendments to section 304(g) of the FD&C Act take effect. FDA is opening a docket for 30 days to solicit input from all relevant stakeholders regarding FDA’s issuance of a regulation for the administrative detention of drugs. This docket is intended to ensure that stakeholders have an opportunity to provide comments before FDA issues regulations on administrative detention with E:\FR\FM\09APP1.SGM 09APP1 21086 Federal Register / Vol. 78, No. 68 / Tuesday, April 9, 2013 / Proposed Rules respect to drugs and that such information submitted to FDA is available to all interested persons in a timely fashion. II. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments will be posted to the docket at https://www.regulations.gov and may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: April 3, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–08120 Filed 4–8–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS–R8–ES–2013–0034; 4500030114] Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List Two Populations of Black-Backed Woodpecker as Endangered or Threatened Fish and Wildlife Service, Interior. ACTION: Notice of petition finding and initiation of status review. tkelley on DSK3SPTVN1PROD with PROPOSALS AGENCY: SUMMARY: We, the U.S. Fish and Wildlife Service (Service), announce a 90-day finding on a petition to list the Oregon Cascades-California population and Black Hills population of the blackbacked woodpecker (Picoides arcticus) under the Endangered Species Act of 1973, as amended (Act), as subspecies or distinct population segments (DPSs) that are endangered or threatened, and to designate critical habitat concurrent with listing. Based on our review, we find that the petition presents substantial scientific or commercial information indicating that listing the Oregon Cascades-California and Black Hills populations of the black-backed woodpecker as subspecies or DPSs may be warranted. Therefore, with the publication of this notice, we are notifying the public that, when funds become available, we will be initiating VerDate Mar<15>2010 16:18 Apr 08, 2013 Jkt 229001 a review of the status of the two populations to determine if listing either or both the Oregon Cascades-California population and the Black Hills population as either subspecies or DPSs is warranted. To ensure that this status review is comprehensive, we are requesting scientific and commercial data and other information regarding these two populations. Based on the status review, we will issue a 12-month finding on the petition, which will address whether the petitioned action is warranted, as provided in section 4(b)(3)(B) of the Act. DATES: We request that we receive information on or before June 10, 2013. The deadline for submitting an electronic comment using the Federal eRulemaking Portal (see ADDRESSES section, below) is 11:59 p.m. Eastern Time on this date. After June 10, 2013, you must submit information directly to the Division of Policy and Directives Management (see ADDRESSES section, below). Please note that we might not be able to address or incorporate information that we receive after the above requested date. ADDRESSES: You may submit information by one of the following methods: (1) Electronically: Go to the Federal eRulemaking Portal: https:// www.regulations.gov. Search for Docket No. FWS–R8–ES–2013–0034, which is the docket number for this action. Then click on the Search button. You may submit information for consideration in our status review by clicking on ‘‘Comment Now!’’ (2) By hard copy: Submit by U.S. mail or hand-delivery to: Public Comments Processing, Attn: FWS–R8–ES–2013– 0034; Division of Policy and Directives Management; U.S. Fish and Wildlife Service; 4401 N. Fairfax Drive, MS 2042–PDM; Arlington, VA 22203. We will not accept emails or faxes. We will post all information we receive on https://www.regulations.gov. This generally means that we will post any personal information you provide us (see the Request for Information section below for more details). FOR FURTHER INFORMATION CONTACT: Karen Leyse, Listing Coordinator, U.S. Fish and Wildlife Service, Sacramento Fish and Wildlife Office, 2800 Cottage Way, Room W–2605, Sacramento, CA 95825; by telephone at 916–414–6600; or by facsimile at 916–414–6712. If you use a telecommunications device for the deaf (TDD), please call the Federal Information Relay Service (FIRS) at 800–877–8339. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 Request for Information When we make a finding that a petition presents substantial information indicating that listing a species may be warranted, we are required to initiate review of the status of the species (status review). For the status review to be complete and based on the best available scientific and commercial information, we request information on the Oregon CascadesCalifornia population and the Black Hills population of the black-backed woodpecker from governmental agencies, Native American tribes, the scientific community, industry, and any other interested parties. We seek information on: (1) The species’ biology, range, and population trends, including: (a) Habitat requirements for feeding, breeding, and sheltering; (b) Genetics and taxonomy of the Oregon Cascades-California and the Black Hills populations of the blackbacked woodpecker, including information that would pertain to whether either, or both, populations can be listed under the Act (16 U.S.C. 1531 et seq.) as either subspecies or DPSs; (c) Historical and current range including distribution patterns, and presence or absence of physical, physiological, or behavioral barriers to movement between populations; (d) Historical and current population levels, and current and projected trends; and (e) Past and ongoing conservation measures for the species, its habitat, or both. (2) The factors that are the basis for making a listing determination for a species under section 4(a) of the Act, which are: (a) The present or threatened destruction, modification, or curtailment of its habitat or range; (b) Overutilization for commercial, recreational, scientific, or educational purposes; (c) Disease or predation; (d) The inadequacy of existing regulatory mechanisms; or (e) Other natural or manmade factors affecting its continued existence. If, after the status review, we determine that listing either an Oregon Cascades-California population or a Black Hills population of the blackbacked woodpecker is warranted, we will propose critical habitat (see definition in section 3(5)(A) of the Act) under section 4 of the Act, to the maximum extent prudent and determinable at the time we propose to list the species. Therefore, we also request data and information on: E:\FR\FM\09APP1.SGM 09APP1

Agencies

[Federal Register Volume 78, Number 68 (Tuesday, April 9, 2013)]
[Proposed Rules]
[Pages 21085-21086]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08120]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2013-N-0365]


Establishment of a Public Docket for Administrative Detention 
Under the Food and Drug Administration Safety and Innovation Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Establishment of docket; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
establishment of a public docket for comments pertaining to the 
implementation of its administrative detention authority with respect 
to drugs under the Food and Drug Administration Safety and Innovation 
Act (FDASIA). This document is intended to solicit input from all 
relevant stakeholders before FDA issues regulations to implement its 
administrative detention authority with respect to drugs and to 
announce that such information submitted to FDA is available to all 
interested persons in a timely fashion.

DATES: Submit electronic or written comments by May 9, 2013.

ADDRESSES: Submit electronic comments to https://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Charlotte Hinkle, Office of Regulatory 
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, rm. 4345, Silver Spring, MD 20993-0002, 301-796-5300, 
FDASIAImplementationORA@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    On July 9, 2012, President Obama signed FDASIA (Pub. L. 112-144) 
into law. Section 709 of FDASIA amends section 304(g) of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 334(g)) to 
provide FDA administrative detention authority with respect to drugs. 
Section 304(g) of the FD&C Act, as amended by FDASIA, provides FDA the 
same authority to detain drugs that section 304(g) had already provided 
FDA with respect to devices and tobacco products.
    Section 709 of FDASIA requires the Secretary to ``consult with 
stakeholders, including manufacturers of drugs'' before issuing 
implementing regulations. Section 709 also provides that FDA must issue 
a final rule to implement its administrative detention authority with 
respect to drugs before the amendments to section 304(g) of the FD&C 
Act take effect.
    FDA is opening a docket for 30 days to solicit input from all 
relevant stakeholders regarding FDA's issuance of a regulation for the 
administrative detention of drugs. This docket is intended to ensure 
that stakeholders have an opportunity to provide comments before FDA 
issues regulations on administrative detention with

[[Page 21086]]

respect to drugs and that such information submitted to FDA is 
available to all interested persons in a timely fashion.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
will be posted to the docket at https://www.regulations.gov and may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: April 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08120 Filed 4-8-13; 8:45 am]
BILLING CODE 4160-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.