Вы находитесь на странице: 1из 2

Federal Register / Vol. 71, No.

159 / Thursday, August 17, 2006 / Notices 47499

DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND Prior to the mid-1990’s, heparin
HUMAN SERVICES HUMAN SERVICES catheter lock-flush solution products
were regulated under the new drug and
Food and Drug Administration Food and Drug Administration abbreviated new drug provisions of the
Federal Food, Drug, and Cosmetic Act
Heparin Catheter Lock-Flush (the act), with CDER serving as the lead
[Docket No. 2005N–0500] Solutions; Transfer of Primary agency review component. Many of the
Responsibility from Center for Drug available marketed products were
Agency Information Collection
Evaluation and Research to Center for approved under abbreviated new drug
Activities; Announcement of Office of Devices and Radiological Health
Management and Budget Approval; applications (‘‘generic drugs’’).
Requirements for Collection of Data AGENCY: Food and Drug Administration, However, more recently, based on
Relating to the Prevention of Medical HHS. several jurisdictional determinations by
ACTION: Notice; announcement of FDA for specific products, applications
Gas Mixups at Health Care Facilities—
transfer. for catheter lock-flush solutions
Survey
containing anticoagulant, such as
SUMMARY: The Food and Drug heparin, or antimicrobial components
AGENCY: Food and Drug Administration,
Administration (FDA) is announcing the have been assigned to CDRH and
HHS.
transfer of primary responsibility for the regulated under the device provisions of
ACTION: Notice. regulation of heparin catheter lock-flush the act. FDA is now transferring the
solution products from the Center for applications for heparin catheter lock-
SUMMARY: The Food and Drug Drug Evaluation and Research (CDER) to flush solution products that are in CDER
Administration (FDA) is announcing the Center for Devices and Radiological to reflect these more current
that a collection of information entitled Health (CDRH). These products are jurisdictional determinations.
≥Requirements for Collection of Data combination drug-device products. The Heparin catheter lock-flush solutions
transfer of lead review responsibility to are intended to maintain patency when
Relating to the Prevention of Medical
CDRH is based on FDA’s determination the catheter is not being used to sample
Gas Mixups at Health Care Facilities—
that the primary mode of action for blood, monitor blood pressure, or
Survey≥ has been approved by the administer fluids to the patient. The
these heparin catheter lock-flush
Office of Management and Budget solution component of the product (i.e.,
solution products is that of the device
(OMB) under the Paperwork Reduction sterile saline or sterile water) acts by
part of the combination. The transfer
Act of 1995. provides consistency and efficiency in physically occupying space within the
FOR FURTHER INFORMATION CONTACT: Liz the regulation of these combination intravenous catheter and exerting
Berbakos, Office of Management products by treating like products pressure on the patient’s circulating
Programs (HFA–250), Food and Drug similarly. blood. This action helps to prevent the
Administration, 5600 Fishers Lane, patient’s blood from backfilling into the
DATES: The effective date of the transfer
catheter, clotting, and contributing to
Rockville, MD 20857, 301–827–1482. is October 16, 2006. microbial contamination. When acting
SUPPLEMENTARY INFORMATION: In the FOR FURTHER INFORMATION CONTACT: in this way, the solution meets the
Federal Register of May 25, 2006 (71 FR For information regarding this notice: definition of a device in the act in that
James S. Cohen, Office of the it affects the structure or function of the
30146), the agency announced that the
Commissioner (HFG–3), Food and body, and does not achieve its primary
proposed information collection had
Drug Administration, 15800 Crabbs intended purposes through chemical or
been submitted to OMB for review and Branch Way, Rockville, MD 20855,
clearance under 44 U.S.C. 3507. An metabolic action (21 U.S.C. 321(h)).
301–427–1934. Likewise, the heparin (i.e. the
agency may not conduct or sponsor, and For questions on what to submit in the
a person is not required to respond to, anticoagulant) component of the
510(k) submission: Sheila A. product meets the definition of a drug
a collection of information unless it Murphe, Center for Devices and
displays a currently valid OMB control in that it is intended for use in the
Radiological Health (HFZ–480), diagnosis, cure, mitigation, treatment, or
number. OMB has now approved the Food and Drug Administration, prevention of disease in man, and is
information collection and has assigned 9200 Corporate Blvd., rm. 350AA, intended to affect the structure or
OMB control number 0910–0548. The Rockville, MD 20850, 301–443– function of the body of man (21 U.S.C.
approval expires on August 31, 2008. A 8913, ext. 203. 321(g)).
copy of the supporting statement for this SUPPLEMENTARY INFORMATION: Heparin Catheter lock-flush solutions that
information collection is available on catheter lock-flush solution products are contain both drug and device
the Internet at http://www.fda.gov/ intended to enhance the performance of components are combination products
ohrms/dockets. intravascular catheters. An intravascular as defined in 21 CFR 3.2(e)(1). FDA is
Dated: August 10, 2006.
catheter is a device that consists of a responsible for assigning combination
slender tube and any necessary products to a lead agency Center for
Jeffrey Shuren,
connecting fittings that are inserted into regulation based upon the agency’s
Assistant Commissioner for Policy. a patient’s vascular system for short- determination of the combination
[FR Doc. E6–13565 Filed 8–16–06; 8:45 am] term use (less than 30 days) to sample product’s ‘‘primary mode of action.’’
BILLING CODE 4160–01–S blood, monitor blood pressure, or (See 21 U.S.C. 353(g)(1) and 21 CFR
administer fluids intravenously. 3.4.) FDA has determined that the
Heparin catheter lock-flush solutions primary mode of action of heparin
rwilkins on PROD1PC63 with NOTICES

are periodically inserted into and stored catheter lock-flush solution products in
within the catheter to keep the catheter maintaining catheter patency is
patent and to prevent blood from attributable to the device component’s
clotting within the catheter between role in physically occupying space and
uses. applying pressure within the catheter.

VerDate Aug<31>2005 16:36 Aug 16, 2006 Jkt 208001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\FR\FM\17AUN1.SGM 17AUN1
47500 Federal Register / Vol. 71, No. 159 / Thursday, August 17, 2006 / Notices

FDA likewise has determined that the (part 807 (21 CFR part 807)). The SUMMARY: The Food and Drug
drug component of the product transferred products will be subject to Administration (FDA) is announcing a
(heparin) performs a secondary role by the general control provisions of section public meeting entitled ‘‘Preparation for
acting chemically to prevent thrombotic 513 of the act, including the Registration ICH meetings in Chicago, Illinois’’ to
occlusions within the catheter. and Listing regulation (part 807), the provide information and receive
Accordingly, to enhance consistency Quality System Regulation (part 820 (21 comments on the International
and efficiency in the regulation of these CFR part 820)), and the Medical Device Conference on Harmonization (ICH) as
combination products by treating like Reporting regulation (21 CFR part 803). well as the upcoming meetings in
products similarly, FDA is transferring Manufacturers planning to change or Chicago, IL. The topics to be discussed
primary review responsibility from modify the design, components, method are the topics for discussion at the
CDER to CDRH for heparin catheter of manufacture, or intended use of a forthcoming ICH Steering Committee
lock-flush solution products that have transferred heparin catheter lock-flush Meeting. The purpose of the meeting is
been regulated under the drug solution product should evaluate to solicit public input prior to the next
provisions of the act. The transferred whether a 510(k) submission is required Steering Committee and Expert Working
products will be reviewed and regulated for the change or modification as set Groups meetings in Chicago, IL, October
under the device provisions of the act. forth in § 807.81(a)(3). If a 510(k) 23 through 26, 2006, at which
As with all combination products, submission is required, the discussion of the topics underway and
CDRH will consult with CDER regarding manufacturer should cite in its initial the future of ICH will continue.
the drug components of these products submission the NDA or ANDA number Date and Time: The meeting will be
as appropriate. Catheter lock-flush held for the product and include a copy held on Monday, October 2, 2006, from
solutions that contain only water or of the letter sent from FDA notifying the 1:30 p.m. to 4 p.m.
saline are considered devices rather sponsor of the transfer of review Location: The meeting will be held at
than combination products and are responsibility to CDRH. 5600 Fishers Lane, 3d Fl., Conference
regulated under the device provisions of FDA finds that there is a substantial Room G, Rockville, MD 20857. For
the act. likelihood that failure to comply with security reasons, all attendees are asked
The agency intends to assist the Quality System Regulation (part to arrive no later than 1:25 p.m., as you
manufacturers of currently marketed 820) for this product will potentially will be escorted from the front entrance
heparin catheter lock- flush solution present a serious risk to human health. of 5600 Fishers Lane to Conference
products in the transition from Therefore, future 510(k) submissions for Room G.
approved new drug applications (NDAs) heparin catheter lock-flush solution Contact Person: Tammie Bell, Office
or approved abbreviated new drug products will be subject to pre-clearance of the Commissioner (HFG–1), Food and
applications (ANDAs) to 510(k) inspections in accordance with section Drug Administration, 5600 Fishers
submissions under the device Lane, Rockville, MD 20857, 301–827–
513(f)(5) of the act (21 U.S.C. 360c).
provisions of the act. Based upon the 0919, e-mail:
FDA will contact applicants holding
submissions made and the prior review Tammie.Bell2@fda.hhs.gov, FAX: 301–
approved NDAs or ANDAs that it
of these products under the drug 480–0716.
believes have products affected by this
provisions of the act, FDA has Registration and Requests for Oral
transfer. Holders of applications subject
determined that heparin catheter lock- Presentations: Send registration
to transfer, holders of applications for
flush solution products approved under information (including name, title, firm
discontinued heparin catheter lock-
these particular approved NDAs or name, address, telephone, and fax
flush solutions products, or holders of
ANDAs are substantially equivalent to number), written material and requests
applications for catheter lock-flush
heparin catheter lock-flush solution to make oral presentations, to the
products cleared for marketing under solution products with other ingredients
who are uncertain as to which agency contact person by September 25, 2006.
section 510(k) of the act (21 U.S.C. If you need special accommodations
360(k)) and the approved NDAs or Center has primary jurisdiction, should
contact James S. Cohen (see the FOR due to a disability, please contact
ANDAs will be considered cleared Tammie Bell at least 7 days in advance.
FURTHER INFORMATION CONTACT section).
device premarket notifications (510(k)
clearances) under section 510(k) when Dated: August 9, 2006. SUPPLEMENTARY INFORMATION: The ICH
FDA has provided the sponsor written Jeffrey Shuren, was established in 1990 as a joint
notification of the transfer and its regulatory/industry project to improve,
Assistant Commissioner for Policy.
effective date. No application user fees through harmonization, the efficiency of
[FR Doc. E6–13509 Filed 8–16–06; 8:45 am]
will be assessed for this administrative the process for developing and
BILLING CODE 4160–01–S
transfer. NDA and ANDA manufacturers registering new medicinal products in
that have previously notified FDA (i.e. Europe, Japan, and the United States
before the date of this notice) that they without compromising the regulatory
DEPARTMENT OF HEALTH AND
have discontinued marketing their obligations of safety and effectiveness.
HUMAN SERVICES
heparin catheter lock-flush solution In recent years, many important
products will be subject to review and Food and Drug Administration initiatives have been undertaken by
clearance of a 510(k) submission prior to regulatory authorities and industry
marketing their product again. [Docket No. 2006N–0312] associations to promote international
Heparin catheter lock-flush solution harmonization of regulatory
products are accessories to, and Preparation for International requirements. FDA has participated in
regulated along with, intravascular Conference on Harmonization many meetings designed to enhance
catheters as Class II devices (special Meetings in Chicago, Illinois; Public harmonization and is committed to
rwilkins on PROD1PC63 with NOTICES

controls). (See 21 CFR 880.5200.) Upon Meeting seeking scientifically based harmonized
the effective date of the transfer, the AGENCY: Food and Drug Administration, technical procedures for pharmaceutical
transferred products will be subject to HHS. development. One of the goals of
the provisions of section 510(k) of the harmonization is to identify and then
ACTION: Notice of meeting.
act and its implementing regulations reduce differences in technical

VerDate Aug<31>2005 16:36 Aug 16, 2006 Jkt 208001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\FR\FM\17AUN1.SGM 17AUN1