Okaloosa County BOCC — November 15, 2016 — Policy on the Non-Aeronautical Use of Airport Hangars — reading text

use of a hangar for non-aeronautical land requires advance written approval airport sponsor may permit non- purposes for a period of 3 to 5 years. from the FAA Office of Airports in aeronautical items to be stored in The FAA will review the request in accordance with Order 5190.6B chapter hangars provided the items do not accordance with Order 5190.6B 22. VerDate Sep<11>2014 14:36 Jun 14, 2016 Jkt 238001 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 E:\FR\FM\15JNR1.SGM 15JNR1  Federal Register / Vol. 81, No. 115 / Wednesday, June 15, 2016 / Rules and Regulations 38911 IV. Use of Hangars for Construction of d. Sponsors should also consider FOR FURTHER INFORMATION CONTACT: For an Aircraft including a provision in airport leases, information concerning the final rule as Non-commercial construction of including aeronautical leases, to adjust it relates to devices regulated by the amateur-built or kit-built aircraft is rental rates to FMV for any non- Center for Devices and Radiological considered an aeronautical activity. As incidental non-aeronautical use of the Health (CDRH): Antoinette (Tosia) with any aeronautical activity, an leased facilities. In other words, if a Hazlett, Center for Devices and airport sponsor may lease or approve tenant uses a hangar for a non- Radiological Health, Food and Drug the lease of hangar space for this activity aeronautical purpose in violation of this Administration, Bldg. 66, Rm. 5424, without FAA approval. Airport sponsors policy, the rental payments due to the 10903 New Hampshire Ave., Silver are not required to construct special sponsor would automatically increase to Spring, MD 20993–0002, 301–796–6119, facilities or upgrade existing facilities a FMV level. email: Tosia.Hazlett@fda.hhs.gov. for construction activities. Airport e. FAA personnel conducting a land For information concerning the final sponsors are urged to consider the use or compliance inspection of an rule as it relates to devices regulated by appropriate safety measures to airport may request a copy of the the Center for Biologics Evaluation and accommodate these users. sponsor’s hangar use program and Research: Stephen Ripley, Center for Airport sponsors also should consider evidence that the sponsor has limited Biologics Evaluation and Research, incorporating construction progress hangars to aeronautical use. Food and Drug Administration, 10903 targets in the lease to ensure that the The FAA may disapprove an AIP New Hampshire Ave., Bldg. 71, Rm. hangar will be used for final assembly grant for hangar construction if there are 7301, Silver Spring, MD 20993–0002, and storage of an operational aircraft existing hangars at the airport being 240–402–7911. within a reasonable term after project used for non-aeronautical purposes. SUPPLEMENTARY INFORMATION: start. Issued in Washington, DC, on the 9th of Executive Summary V. No Right to Non-Aeronautical Use June 2016. Robin K. Hunt, Purpose of the Regulatory Action In the context of enforcement of the Acting Director, Office of Airport Compliance The final rule explicitly permits the Grant Assurances, this policy allows and Management Analysis. use of symbols in medical device some incidental storage of non- aeronautical items in hangars that do [FR Doc. 2016–14133 Filed 6–14–16; 8:45 am] labeling without adjacent explanatory not interfere with aeronautical use. BILLING CODE 4910–13–P text if certain requirements are met. The However, the policy neither creates nor medical device industry has requested constitutes a right to store non- the ability to use stand-alone symbols aeronautical items in hangars. Airport DEPARTMENT OF HEALTH AND on domestic device labeling, consistent sponsors may restrict or prohibit storage HUMAN SERVICES with their current use on devices of non-aeronautical items. Sponsors manufactured for European and other should consider factors such as Food and Drug Administration foreign markets. The final rule seeks to emergency access, fire codes, security, harmonize the U.S. device labeling insurance, and the impact of vehicular 21 CFR Parts 660, 801, and 809 requirements for symbols with traffic on their surface areas when international regulatory requirements, [Docket No. FDA–2013–N–0125] such as the Medical Device Directive enacting rules regarding hangar storage. In some cases, permitting certain RIN 0910–AG74 93/42/EEC of the European Union (EU) incidental non-aeronautical items in (the European Medical Device Directive) hangars could inhibit the sponsor’s Use of Symbols in Labeling and global adoption of International ability to meet obligations associated Electrotechnical Commission (IEC) AGENCY: Food and Drug Administration, standard IEC 60417 and International with Grant Assurance 19, Operations HHS. and Maintenance. To avoid claims of Organization for Standardization (ISO) discrimination, sponsors should impose ACTION: Final rule. standard ISO 7000–DB that govern the consistent rules for incidental storage in use of device symbols in numerous SUMMARY: The Food and Drug foreign markets. all similar facilities at the airport. Administration (FDA or the Agency) is Sponsors should ensure that taxiways issuing this final rule revising its Summary of the Major Provisions of the and runways are not used for the medical device and certain biological Regulatory Action in Question vehicular transport of such items to or product labeling regulations to from the hangars. FDA has generally interpreted explicitly allow for the optional existing regulations not to allow the use VI. Sponsor Compliance Actions inclusion of graphical representations of of symbols in medical device labeling, a. It is expected that aeronautical information, or symbols, in labeling except with adjacent English-language facilities on an airport will be available (including labels) without adjacent explanatory text and/or on in vitro and used for aeronautical purposes in explanatory text (referred to in this