80 FR 18307 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Urethral Insert With Pump for Bladder Drainage
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 65 (April 6, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 65 (April 6, 2015)
| Page Range | 18307-18310 | |
| FR Document | 2015-07815 |
[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)] [Rules and Regulations] [Pages 18307-18310] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-07815] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 876 [Docket No. FDA-2015-N-0804] Medical Devices; Gastroenterology-Urology Devices; Classification of the Urethral Insert With Pump for Bladder Drainage AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the urethral insert with pump for bladder drainage into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the urethral insert with pump for bladder drainage's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. DATES: This order is effective April 6, 2015. The classification was applicable on October 14, 2014. FOR FURTHER INFORMATION CONTACT: John Baxley, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G210, Silver Spring, MD 20993-0002, 301-796-6549. SUPPLEMENTARY INFORMATION: I. Background In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations. [[Page 18308]] Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112- 144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of ``low-moderate risk'' or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed. In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device. On October 25, 2013, Vesiflo, Inc., submitted a request for classification of the inFlowTM Intraurethral Valve-Pump and Activator under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1). In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on October 14, 2014, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding Sec. 876.5140. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a urethral insert with pump for bladder drainage will need to comply with the special controls named in this final order. The device is assigned the generic name urethral insert with pump for bladder drainage, and it is identified as a catheter-like device with internal pump mechanism that is placed in the urethra. Under patient control the internal pump draws urine out of the bladder when voiding is desired, and blocks urine flow when continence is desired. The device is intended for use by women who cannot empty their bladder due to impaired detrusor contractility. FDA has identified the following risks to health associated specifically with this type of device, as well as the measures required to mitigate these risks in table 1. Table 1--Urethral Insert With Pump for Bladder Drainage Risks and Mitigation Measures ---------------------------------------------------------------------------------------------------------------- Identified risk Mitigation measure ---------------------------------------------------------------------------------------------------------------- Adverse Tissue Reaction..................... Biocompatibility Testing. Infection................................... Sterilization Validation. Clinical Testing. Labeling. Reflux or Renal Damage...................... Non-Clinical (Bench) Testing. Clinical Testing. Labeling. Urethral/Bladder Wall Trauma................ Clinical Testing. Labeling. Urinary Frequency/Urgency................... Clinical Testing. Labeling. Device Encrustation......................... Non-Clinical (Bench) Testing. Labeling. Device Migration............................ Non-Clinical (Bench) Testing. Clinical Testing. Device Malfunction.......................... Non-Clinical (Bench) Testing. Labeling. Urine Leakage............................... Non-Clinical (Bench) Testing. Labeling. Discomfort.................................. Clinical Testing. Labeling. ---------------------------------------------------------------------------------------------------------------- FDA believes that the following special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness:The elements of the device that may contact the urinary tract must be demonstrated to be biocompatible. Performance data must demonstrate the sterility of the device components that contact the urinary tract. Performance data must support shelf life by demonstrating continued sterility of the device (or the sterile components), package integrity, and device functionality over the requested shelf life. [[Page 18309]] Non-clinical testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: [cir] Urine flow rate testing. [cir] Valve integrity testing. [cir] Bladder neck retention force testing. [cir] Pump/valve endurance testing. [cir] Encrustation testing. [cir] Remote control reliability, mechanical integrity, and battery life testing. Clinical testing must demonstrate safe and effective use, document the device acceptance rate and the adverse event profile associated with clinical use, and demonstrate that the device performs as intended under anticipated conditions of use. Labeling must include: [cir] Specific instructions, contraindications, warnings, cautions, limitations, and the clinical training needed for the safe use of the device. [cir] Statement of the maximum insert indwelling period. [cir] Information on the patient education and support program prior to and during initial device use. [cir] Information on the patient population for which the device has been demonstrated to be safe and effective. [cir] Information on how the device operates and the recommended treatment regimen. [cir] A detailed summary of the device- and procedure-related complications or adverse events pertinent to use of the device. [cir] An expiration date/shelf life. Patient labeling must be provided and must include: [cir] Relevant contraindications, warnings, precautions, and adverse events/complications. [cir] Information on how the device operates and the recommended treatment regimen. [cir] Information on the patient education and support program prior to and during initial device use. [cir] Information on the patient population for which there is clinical evidence of safety and effectiveness. [cir] The potential risks and benefits associated with the use of the device. [cir] Post-insertion care instructions. [cir] Alternative treatments. Urethral inserts with pump for bladder drainage are prescription devices restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device; see section 520(e) of the FD&C Act (21 U.S.C. 360j(e)) and 21 CFR 801.109 (Prescription devices). Prescription-use restrictions are a type of general controls as defined in section 513(a)(1)(A)(i) of the FD&C Act. Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k), if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the urethral inserts with pump for bladder drainage they intend to market. II. Environmental Impact The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. III. Paperwork Reduction Act of 1995 This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485. IV. Reference The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and is available electronically at http://www.regulations.gov. 1. DEN130044: De Novo Request per 513(f)(2) from Vesiflo, Inc., dated October 25, 2013. List of Subjects in 21 CFR Part 876 Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 876 is amended as follows: PART 876--GASTROENTEROLOGY-UROLOGY DEVICES 0 1. The authority citation for 21 CFR part 876 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 876.5140 to subpart F to read as follows: Sec. 876.5140 Urethral insert with pump for bladder drainage. (a) Identification. A urethral insert with pump for bladder drainage is a catheter-like device with internal pump mechanism that is placed in the urethra. Under patient control the internal pump draws urine out of the bladder when voiding is desired, and blocks urine flow when continence is desired. The device is intended for use by women who cannot empty their bladder due to impaired detrusor contractility. (b) Classification. Class II (special controls). The special controls for this device are: (1) The elements of the device that may contact the urinary tract must be demonstrated to be biocompatible. (2) Performance data must demonstrate the sterility of the device components that contact the urinary tract. (3) Performance data must support shelf life by demonstrating continued sterility of the device (or the sterile components), package integrity, and device functionality over the requested shelf life. (4) Non-clinical testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Urine flow rate testing. (ii) Valve integrity testing. (iii) Bladder neck retention force testing. (iv) Pump/valve endurance testing. (v) Encrustation testing. (vi) Remote control reliability, mechanical integrity, and battery life testing. (5) Clinical testing must demonstrate safe and effective use, document the device acceptance rate and the adverse event profile associated with clinical use, and demonstrate that the device performs as intended under anticipated conditions of use. [[Page 18310]] (6) Labeling must include: (i) Specific instructions, contraindications, warnings, cautions, limitations, and the clinical training needed for the safe use of the device. (ii) Statement of the maximum insert indwelling period. (iii) Information on the patient education and support program prior to and during initial device use. (iv) Information on the patient population for which the device has been demonstrated to be safe and effective. (v) Information on how the device operates and the recommended treatment regimen. (vi) A detailed summary of the device- and procedure-related complications or adverse events pertinent to use of the device. (vii) An expiration date/shelf life. (7) Patient labeling must be provided and must include: (i) Relevant contraindications, warnings, precautions, and adverse events/complications. (ii) Information on how the device operates and the recommended treatment regimen. (iii) Information on the patient education and support program prior to and during initial device use. (iv) Information on the patient population for which there is clinical evidence of safety and effectiveness. (v) The potential risks and benefits associated with the use of the device. (vi) Post-insertion care instructions. (vii) Alternative treatments. Dated: March 31, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-07815 Filed 4-3-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Rules and Regulations 18307
the ground or flight path in normal taxi products and issues that will be brought DEPARTMENT OF HEALTH AND
and flight attitudes of the airplane. This to the committee. The change became HUMAN SERVICES
means must be designed to function, effective March 4, 2015.
without continuous attention on the Food and Drug Administration
Therefore, the Agency is amending 21
part of the flightcrew, in conditions CFR 14.100(c) as set forth in the
from light misting precipitation to heavy 21 CFR Part 876
regulatory text of this document.
rain, at speeds from fully stopped in [Docket No. FDA–2015–N–0804]
still air, to 1.5 VSR1 with lift and drag Under 5 U.S.C. 553(b)(3)(B) and (d)
devices retracted. and 21 CFR 10.40(d) and (e), the Agency Medical Devices; Gastroenterology-
Issued in Renton, Washington, on March
finds good cause to dispense with notice Urology Devices; Classification of the
27, 2015. and public comment procedures and to Urethral Insert With Pump for Bladder
Michael Kazycki, proceed to an immediate effective date Drainage
Acting Manager, Transport Airplane on this rule. Notice and public comment
and a delayed effective date are AGENCY: Food and Drug Administration,
Directorate, Aircraft Certification Service.
unnecessary and are not in the public HHS.
[FR Doc. 2015–07713 Filed 4–3–15; 8:45 am]
interest as this final rule merely ACTION: Final order.
BILLING CODE 4910–13–P
removes the name of the Anti-Infective
SUMMARY: The Food and Drug
Drugs Advisory Committee from the list
Administration (FDA) is classifying the
DEPARTMENT OF HEALTH AND of standing advisory committees in 21
urethral insert with pump for bladder
HUMAN SERVICES CFR 14.100 and replaces it with the drainage into class II (special controls).
Antimicrobial Drugs Advisory The special controls that will apply to
Food and Drug Administration Committee. the device are identified in this order
List of Subjects in 21 CFR Part 14 and will be part of the codified language
21 CFR Part 14 for the urethral insert with pump for
[Docket No. FDA–2009–N–0443] Administrative practice and bladder drainage’s classification. The
procedure, Advisory committees, Color Agency is classifying the device into
Advisory Committee; Anti-Infective additives, Drugs, Radiation protection. class II (special controls) in order to
Drugs Advisory Committee provide a reasonable assurance of safety
Therefore, under the Federal Food, and effectiveness of the device.
AGENCY: Food and Drug Administration, Drug, and Cosmetic Act and under
HHS. DATES: This order is effective April 6,
authority delegated to the Commissioner
2015. The classification was applicable
ACTION: Final rule. of Food and Drugs, 21 CFR part 14 is
on October 14, 2014.
amended as follows:
SUMMARY: The Food and Drug FOR FURTHER INFORMATION CONTACT: John
Administration (FDA) is amending the PART 14—PUBLIC HEARING BEFORE Baxley, Center for Devices and
standing advisory committees’ A PUBLIC ADVISORY COMMITTEE Radiological Health, Food and Drug
regulations to change the name of the Administration, 10903 New Hampshire
Anti-Infective Drugs Advisory ■ 1. The authority citation for 21 CFR Ave., Bldg. 66, Rm. G210, Silver Spring,
Committee. This action is being taken to part 14 continues to read as follows: MD 20993–0002, 301–796–6549.
change the name of this committee on SUPPLEMENTARY INFORMATION:
the Agency’s list of standing advisory Authority: 5 U.S.C. App. 2; 15 U.S.C.
committees. 1451–1461; 21 U.S.C. 41–50, 141–149, 321– I. Background
394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 In accordance with section 513(f)(1) of
DATES: This rule is effective April 6, U.S.C. 201, 262, 263b, 264; Pub. L. 107–109;
2015. The name change became the Federal Food, Drug, and Cosmetic
Pub. L. 108–155; Pub. L. 113–54.
applicable March 4, 2015. Act (the FD&C Act) (21 U.S.C.
360c(f)(1)), devices that were not in
FOR FURTHER INFORMATION CONTACT: ■ 2. Amend § 14.100 by revising
commercial distribution before May 28,
Michael Ortwerth, Advisory Committee paragraph (c)(2) introductory text to 1976 (the date of enactment of the
Oversight and Management Staff, Food read as follows: Medical Device Amendments of 1976),
and Drug Administration, 10903 New generally referred to as postamendments
Hampshire Ave., Bldg. 32, Rm. 5129, § 14.100 List of standing advisory
committees. devices, are classified automatically by
Silver Spring, MD 20993–0002, FAX: statute into class III without any FDA
301–847–8640, or Michael.Ortwerth@ * * * * *
rulemaking process. These devices
fda.hhs.gov. (c) * * * remain in class III and require
SUPPLEMENTARY INFORMATION: The Anti- (2) Antimicrobial Drugs Advisory premarket approval, unless and until
Infective Drugs Advisory Committee Committee. the device is classified or reclassified
(the Committee) was established on into class I or II, or FDA issues an order
* * * * *
October 7, 1980 (45 FR 79025). The finding the device to be substantially
Committee reviews and evaluates Dated: March 27, 2015. equivalent, in accordance with section
available data concerning the safety and Leslie Kux, 513(i) of the FD&C Act, to a predicate
effectiveness of marketed and Associate Commissioner for Policy. device that does not require premarket
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investigational human drug products for [FR Doc. 2015–07789 Filed 4–3–15; 8:45 am] approval. The Agency determines
use in the treatment of infectious whether new devices are substantially
BILLING CODE 4164–01–P
diseases and disorders. equivalent to predicate devices by
The Committee name has been means of premarket notification
changed to the following: Antimicrobial procedures in section 510(k) of the
Drugs Advisory Committee. The Agency FD&C Act (21 U.S.C. 360(k)) and part
changed the name to better reflect the 807 (21 CFR part 807) of the regulations.
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![18310 Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Rules and Regulations
(6) Labeling must include: vessel San Salvador located in the Table of Acronyms
(i) Specific instructions, Captain of the Port San Diego Zone on DHS Department of Homeland Security
contraindications, warnings, cautions, San Diego Bay. This action is necessary FR Federal Register
limitations, and the clinical training to provide for the safety of life and NPRM Notice of Proposed Rulemaking
needed for the safe use of the device. property on navigable waters during this
(ii) Statement of the maximum insert event. This special local regulation will A. Public Participation and Comments
indwelling period. establish restrictions upon, and control We encourage you to submit
(iii) Information on the patient movement of, vessels in a portion of San comments (or related material) on this
education and support program prior to Diego Bay during the initial launch and temporary final rule. We will consider
and during initial device use. subsequent procession of the San all submissions and may adjust our final
(iv) Information on the patient Salvador around a portion of San Diego action based on your comments.
population for which the device has Bay. Unauthorized persons and vessels Comments should be marked with
been demonstrated to be safe and are prohibited from entering into, docket number USCG–2015–0138 and
effective. transiting through or anchoring within should provide a reason for each
(v) Information on how the device this regulated area unless authorized by suggestion or recommendation. You
operates and the recommended the Captain of the Port, or his should provide personal contact
treatment regimen. designated representative. The Coast information so that we can contact you
(vi) A detailed summary of the device- Guard requests public comments on the if we have questions regarding your
and procedure-related complications or temporary special local regulation. comments; but please note that all
adverse events pertinent to use of the DATES: This rule is effective from 8:00 comments will be posted to the online
device. a.m. to 1:00 p.m. on April 19, 2015. docket without change and that any
(vii) An expiration date/shelf life. Public comments must be received by personal information you include can be
(7) Patient labeling must be provided April 15, 2015. searchable online (see the Federal
and must include: Register Privacy Act notice regarding
ADDRESSES: Submit comments using one
(i) Relevant contraindications, our public dockets, 73 FR 3316, Jan. 17,
of the listed methods, and see
warnings, precautions, and adverse 2008).
SUPPLEMENTARY INFORMATION for more
events/complications. Mailed or hand-delivered comments
information on public comments. should be in an unbound 81⁄2 x 11 inch
(ii) Information on how the device • Online—http://www.regulations.gov
operates and the recommended format suitable for reproduction. The
following Web site instructions.
treatment regimen. • Fax—202–493–2251. Docket Management Facility will
(iii) Information on the patient • Mail or hand deliver—Docket acknowledge receipt of mailed
education and support program prior to Management Facility (M–30), U.S. comments if you enclose a stamped,
and during initial device use. Department of Transportation, West self-addressed postcard or envelope
(iv) Information on the patient Building Ground Floor, Room W12–140, with your submission.
Documents mentioned in this notice
population for which there is clinical 1200 New Jersey Avenue SE.,
and all public comments, are in our
evidence of safety and effectiveness. Washington, DC 20590–0001. Hand
online docket at http://
(v) The potential risks and benefits delivery hours: 9 a.m. to 5 p.m., Monday
www.regulations.gov and can be viewed
associated with the use of the device. through Friday, except Federal holidays
by following the Web site’s instructions.
(vi) Post-insertion care instructions. (telephone 202–366–9329).
You can also view the docket at the
(vii) Alternative treatments. Documents mentioned in this
Docket Management Facility (see the
Dated: March 31, 2015. preamble are part of docket [USCG–
mailing address under ADDRESSES)
2015–0138]. To view documents
Leslie Kux, between 9 a.m. and 5 p.m., Monday
mentioned in this preamble as being
Associate Commissioner for Policy. through Friday, except Federal holidays.
available in the docket, go to http://
[FR Doc. 2015–07815 Filed 4–3–15; 8:45 am] www.regulations.gov, type the docket B. Regulatory History and Information
BILLING CODE 4164–01–P number in the ‘‘SEARCH’’ box and click The San Salvador Launch and
‘‘SEARCH.’’ Click on Open Docket Procession is a onetime marine event
Folder on the line associated with this with no regulatory history. The Coast
DEPARTMENT OF HOMELAND rulemaking. You may also visit the Guard is issuing this temporary final
SECURITY Docket Management Facility in Room rule without prior notice and
W12–140 on the ground floor of the opportunity to comment pursuant to
Coast Guard Department of Transportation West authority under section 4(a) of the
Building, 1200 New Jersey Avenue SE., Administrative Procedure Act (APA) (5
33 CFR Part 100 Washington, DC 20590, between 9 a.m. U.S.C. 553(b)). This provision
[Docket Number USCG–2015–0138] and 5 p.m., Monday through Friday, authorizes an agency to issue a rule
except Federal holidays. without prior notice and opportunity to
RIN 1625–AA08 FOR FURTHER INFORMATION CONTACT: If comment when the agency for good
you have questions on this rule, call or cause finds that those procedures are
Special Local Regulation; San email Petty Officer Randolph Pahilanga,
Salvador Launch and Procession; San ‘‘impracticable, unnecessary, or contrary
Waterways Management, U.S. Coast to the public interest.’’
Diego Bay, San Diego, CA Guard Sector San Diego; telephone (619) Under 5 U.S.C. 553(b)(B), the Coast
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AGENCY:Coast Guard, DHS. 278–7656, email D11-PF- Guard finds that good cause exists for
Temporary final rule; request for
ACTION:
MarineEventsSanDiego@uscg.mil. If you not publishing a notice of proposed
comments. have questions on viewing or submitting rulemaking (NPRM) with respect to this
material to the docket, call Cheryl rule because publishing an NPRM
SUMMARY: The Coast Guard is Collins, Program Manager, Docket would be impracticable since immediate
establishing a marine event special local Operations, telephone (202) 366–9826. action is needed to minimize potential
regulation for the launch of the historic SUPPLEMENTARY INFORMATION: danger to the participants and the
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Document Created: 2015-12-18 11:18:03
Document Modified: 2015-12-18 11:18:03
| 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 order. | |
| Dates | This order is effective April 6, 2015. The classification was applicable on October 14, 2014. | |
| Contact | John Baxley, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G210, Silver Spring, MD 20993-0002, 301-796-6549. | |
| FR Citation | 80 FR 18307 |
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