[Federal Register Volume 77, Number 119 (Wednesday, June 20, 2012)]
[Proposed Rules]
[Pages 36951-36955]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15024]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA-2012-N-0303]
Gastroenterology-Urology Devices; Reclassification of Implanted
Blood Access Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify the implanted blood access device preamendments class III
device into class II (special controls). FDA is proposing this
reclassification on its own initiative based on new information. FDA is
taking this action under the Federal Food, Drug, and Cosmetic Act (the
FD&C Act), as amended by the Medical Device Amendments of 1976 (the
1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food
and Drug Administration Modernization Act of 1997 (FDAMA), and the
Medical Device User Fee and Modernization Act of 2002 (MDUFMA).
DATES: Submit either electronic or written comments on the proposed
rule by September 18, 2012. Please see section XIII of this document
for the effective date of any final rule that may publish based on this
proposal.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-0303 by any of the following methods, except that comments on
information collection issues under the Paperwork Reduction Act of 1995
must be submitted to the Office of Regulatory Affairs, Office of
Management and Budget (OMB) (see the ``Paperwork Reduction Act of
1995'' section of this document).
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
Fax: 301-827-6870.
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and docket number for this rulemaking. All comments received may be
posted without change to http://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
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: Jeffrey Cooper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. G228, Silver Spring, MD 20993, 301-796-6517.
SUPPLEMENTARY INFORMATION:
I. Background--Regulatory Authorities
The FD&C Act, as amended by the 1976 amendments (Pub. L. 94-295),
the SMDA (Pub. L. 101-629), the FDAMA
[[Page 36952]]
(Pub. L. 105-115), the MDUFMA (Pub. L. 107-250), the Medical Devices
Technical Corrections Act (Pub. L. 108-214), and the Food and Drug
Administration Amendments Act of 2007 (Pub. L. 110-85), establish a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established
three categories (classes) of devices, reflecting the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
Under section 513 of the FD&C Act, devices that were in commercial
distribution before the enactment of the 1976 amendments, May 28, 1976
(generally referred to as preamendments devices), are classified after
FDA has: (1) Received a recommendation from a device classification
panel (an FDA advisory committee); (2) published the panel's
recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices) are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
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).
A preamendments device that has been classified into class III may
be marketed by means of premarket notification procedures (510(k)
process) without submission of a premarket approval application (PMA)
until FDA issues a final regulation under section 515(b) of the FD&C
Act (21 U.S.C. 360e(b)) requiring premarket approval.
Section 513(e) of the FD&C Act governs reclassification of
classified preamendments devices. This section provides that FDA may,
by rulemaking, reclassify a device (in a proceeding that parallels the
initial classification proceeding) based upon ``new information.'' FDA
can initiate a reclassification under section 513(e) of the FD&C Act or
an interested person may petition FDA to reclassify a preamendments
device. The term ``new information,'' as used in section 513(e) of the
FD&C Act, includes information developed as a result of a reevaluation
of the data before the Agency when the device was originally
classified, as well as information not presented, not available, or not
developed at that time. (See, e.g., Holland Rantos v. United States
Department of Health, Education, and Welfare, 587 F.2d 1173, 1174 n.1
(D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell
v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent regulatory action where the
reevaluation is made in light of newly available regulatory authority
(see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762
F.Supp. 382, 389-391 (D.D.C. 1991)) or in light of changes in ``medical
science.'' (See Upjohn v. Finch, supra, 422 F.2d at 951). Whether data
before the Agency are past or new data, the ``new information'' to
support reclassification under section 513(e) must be ``valid
scientific evidence,'' as defined in section 513(a)(3) of the FD&C Act
and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770
F.2d 214 (D.C. Cir. 1985); Contact Lens Assoc. v. FDA, 766 F.2d 592
(D.C. Cir.), cert. denied, 474 U.S. 1062 (1985)).
FDA relies upon ``valid scientific evidence'' in the classification
process to determine the level of regulation for devices. To be
considered in the reclassification process, the valid scientific
evidence upon which the Agency relies must be publicly available.
Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
PMA. (See section 520(c) of the FD&C Act (21 U.S.C. 360j(c).) Section
520(h)(4) of the FD&C Act, added by FDAMA, provides that FDA may use,
for reclassification of a device, certain information in a PMA 6 years
after the application has been approved. This includes information from
clinical and preclinical tests or studies that demonstrate the safety
or effectiveness of the device but does not include descriptions of
methods of manufacture or product composition and other trade secrets.
FDAMA added a new section 510(m) to the FD&C Act. New section
510(m) of the FD&C Act provides that a class II device may be exempted
from the premarket notification requirements under section 510(k) of
the FD&C Act, if the Agency determines that premarket notification is
not necessary to assure the safety and effectiveness of the device.
II. Regulatory History of the Device
In the preamble to the proposed rule (46 FR 7616, January 23,
1981), the Gastroenterology-Urology Devices Panel recommended that both
implanted and nonimplanted blood access devices be classified into
class II. Although FDA agreed with the panel recommendation for
nonimplanted blood access devices, FDA disagreed with the panel for
implanted blood access devices and proposed that implanted blood access
devices be classified into class III because FDA believed that the
device presented a potential unreasonable risk of illness or injury to
the patient if there are not adequate data to assure the safe and
effective use of the device. FDA also noted that the implanted blood
access device is part of a life-supporting and life-sustaining system
and that general controls and performance standards were insufficient
to provide reasonable assurance of the safety and effectiveness of
implanted blood access devices. In 1983, FDA classified implanted blood
access devices into class III, but the accessories to these devices
into class II (48 FR 53012, November 23, 1983). In 1987, FDA published
a clarification by inserting language in the codified language stating
that no effective date had been established for the requirement for
premarket approval for implanted blood access devices (52 FR 17732 at
17738, May 11, 1987).
In 2009, FDA published an order for the submission of information
on implanted blood access devices (74 FR 16214, April 9, 2009). In
response to that order, FDA received information in support of
reclassification from 15 device manufacturers who all recommended that
implanted blood access devices be reclassified to class II. The
manufacturers stated that safety and effectiveness of these devices may
be assured by bench testing, biocompatibility testing, sterility
testing, expiration date testing, labeling, and standards.
III. Device Description
Implanted blood access devices include various flexible or rigid
tubes, such as catheters, cannulae or hollow needles. Chronic
hemodialysis catheters are soft, blunt-tipped plastic catheters that
have a subcutaneous ``cuff'' for tissue ingrowth. They are placed in a
central vein to allow blood access. Chronic hemodialysis catheters
serve as
[[Page 36953]]
conduits for the removal of blood from the patient, delivery to a
hemodialysis machine for filtering, and return of filtered blood to the
patient. They have no moving parts, consisting, essentially, of
flexible tubing terminating in rigid Luer lock connectors for
attachment to a dialysis machine. Subcutaneous catheters are totally
implanted below the skin surface with no external communication. AV
Shunts and Vessel Tips are tubing with tapered tips that are inserted
into the artery and vein. The tubing is attached to the roughened or
etched outer surface of the tip. The tubing is external to the skin and
can be accessed with needles. They are similar to the subcutaneous
catheters.
IV. Proposed Reclassification
FDA is proposing that the device subject to this proposal be
reclassified from class III to class II. FDA believes that the
identified special controls would provide reasonable assurance of
safety and effectiveness. Therefore, in accordance with sections 513(e)
and 515(i) of the FD&C Act and 21 CFR 860.130, based on new information
with respect to the devices, FDA, on its own initiative, is proposing
to reclassify this preamendments class III device into class II. The
Agency has identified special controls that would provide reasonable
assurance of their safety and effectiveness. FDA has considered
implanted blood access devices in accordance with the reserved criteria
and decided that the device does require premarket notification. The
Agency does not intend to exempt this proposed class II device from
premarket notification (510(k)) submission as provided for under
section 510(m) of the FD&C Act.
V. Risks to Health
After considering the information from the reports and
recommendations of the advisory committees (panels) for the
classification of these devices along with information submitted in
response to the 515(i) order and any additional information that FDA
has encountered, FDA has evaluated the risks to health associated with
the use of implanted blood access devices and determined that the
following risks to health are associated with its use:
1. Thrombosis in patient and catheter. Inadequate blood
compatibility of the materials used in this device, blood pooling
between dialysis sessions, or turbulent blood pathways could lead to
potentially debilitating or fatal thromboembolism.
2. Adverse tissue reaction. Inadequate tissue compatibility of the
materials used in this device could cause an immune reaction.
3. Infection and pyrogen reactions. An improperly sterilized device
could cause an infection or an unclean device could cause a fever.
4. Device failure. Weakness of connections or materials could lead
to blood loss.
5. Cardiac Arrhythmia, hemorrhage, embolism, nerve injury, or
vessel perforation. Improper placement into the heart or blood vessel
could damage tissues and result in injuries.
6. Hemolysis. The destruction of red blood cells due to turbulence
or high pressure created by narrow openings or changes in blood flow
paths.
VI. Summary of Reasons for Reclassification
FDA believes that implanted blood access devices should be
reclassified into class II because special controls, in addition to
general controls, can be established to provide reasonable assurance of
the safety and effectiveness of the device. In addition, there is now
adequate effectiveness information sufficient to establish special
controls to provide such assurance.
VII. Summary of Data Upon Which the Reclassification is Based
Since 1987 when FDA classified implanted blood access devices into
class III, sufficient evidence has been developed to support a
reclassification to class II with special controls. FDA has been
reviewing these devices for many years and their risks are well known.
The risks include clotting, infection, and breakage of the materials,
and these risks can be adequately mitigated by special controls.
Catheters continue to evolve over time with improved materials and
insertion techniques. A review of 15 publications shows a decrease in
infections and an increase in patency over three decades (1980 to 2010)
(Refs. 2-16). FDA believes that special controls currently in use can
ensure the safety and effectiveness of implanted blood access devices.
VIII. Proposed Special Controls-Related Documents
FDA believes that the special controls as described in the guidance
document ``Class II Special Controls Guidance Document: Implanted Blood
Access Devices for Hemodialysis'' (Ref. (1) are sufficient to mitigate
the risks to health described in section V of this document. Elsewhere
in this issue of the Federal Register, FDA is announcing the
availability of a draft guidance document that, when finalized, would
serve as a special control, if FDA reclassifies this device. If
adopted, following the effective date of a final rule classifying the
device, any firm submitting a 510(k) premarket notification for the
device would need to address the issues covered in the special control
guidance. However, the firm would need to show only that its device
meets the recommendations of the guidance or in some other way provides
equivalent assurances of safety and effectiveness.
IX. Environmental Impact
The Agency has determined under 21 CFR 25.30(h) 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.
X. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612) and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this proposed rule is not a
significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because reclassification of implanted blood access
devices from class III to class II with special controls makes these
devices' formal classification consistent with current FDA and industry
practice, the Agency proposes to certify that the final rule will not
have a significant economic impact on a substantial number of small
entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation)
[[Page 36954]]
in any one year.'' The current threshold after adjustment for inflation
is $136 million, using the most current (2010) Implicit Price Deflator
for the Gross Domestic Product. FDA does not expect this proposed rule
to result in any 1-year expenditure that would meet or exceed this
amount.
FDA is proposing to reclassify implanted blood access devices from
class III to class II with special controls. Typically, a class III
device must be granted premarket approval by FDA. However, at the
present time, implanted blood access devices are handled in a fashion
similar to class II devices, with manufacturers receiving clearance to
market via a 510(k) and no PMA requirement. Hence, this rule brings the
formal classification of implanted blood access devices into line with
current practice and will likely cause little to no change in behavior
on the part of industry, consumers, or FDA. There remains the
possibility that some new actions will be required of industry in light
of the formalization of class II special controls. To the extent that
manufacturers are not already complying with the recommendations
contained in the special controls guidance document, manufacturers will
incur additional costs, which may then be passed on to consumers or
insurance payers in the form of higher prices. We anticipate that such
costs will be negligible, however, because the proposed special
controls for labeling, safety, and performance testing reflect current
FDA requirements for marketing clearance of implanted blood access
devices.
FDA has already recognized that the 510(k) premarket notification
process is sufficient for ensuring the safety and effectiveness of
these products. Firms have not been required to submit PMAs or meet
other requirements typically expected of manufacturers of class III
devices, and the Agency expects that continuing the current 510(k)
clearance process will pose no new risks to consumers. FDA requests
comment on this issue and on all costs and benefits of the proposed
reclassification.
XI. Federalism
FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive order requires Agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.'' Federal law includes an express preemption
provision that preempts certain state requirements ``different from or
in addition to'' certain Federal requirements applicable to devices.
(See section 521 of the FD&C Act (21 U.S.C. 360k); Medtronic, Inc. v.
Lohr, 518 U.S. 470 (1996); and Riegel v. Medtronic, Inc. 128 S. Ct. 999
(2008)). If this proposed rule is made final, the special controls
established by the final rule would create ``requirements'' for
specific medical devices under 21 U.S.C. 360(k), even though product
sponsors have some flexibility in how they meet those requirements (Cf.
Papike v. Tambrands, Inc., 107 F.3d 737, 740-742 (9th Cir. 1997)).
XII. Paperwork Reduction Act of 1995
This proposed rule refers to previously approved collections of
information found in 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 812 have been approved under
OMB control number 0910-0078; the collections of information in part
807 subpart E have been approved under OMB control number 0910-0120;
the collections of information in 21 CFR part 814 subpart B have been
approved under OMB control number 0910-0231; and the collections of
information under 21 CFR part 801 have been approved under OMB control
number 0910-0485.
XIII. Proposed Effective Date
FDA is proposing that any final rule based on this proposal become
effective on the date of its publication in the Federal Register or at
a later date if stated in the final rule.
XIV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. 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 may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
XV. References
The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES), and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has
verified the Web site address, but we are not responsible for any
subsequent changes to the Web site after this document publishes in the
Federal Register.)
1. Draft guidance entitled ``Class II Special Controls Guidance
Document: Implanted Blood Access Devices for Hemodialysis,''
available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
2. Eisenhauer ED, Derveloy RJ, Hastings PR: Prospective evaluation
of central venous pressure (CVP) catheters in a large city-county
hospital. Ann Surg 196:560-564, 1982.
3. Vanholder V, Hoenich N, Ringoir S: Morbidity and mortality of
central venous catheter hemodialysis: a review of 10 years'
experience. Nephron 47:274-279, 1987.
4. Almirall J, Gonzalez J, Rello J, Campistol JM, Montoliu J, Puig
de la Bellacasa J, Revert L, Gatell JM: Infection of hemodialysis
catheters: incidence and mechanisms. Am J Nephrol 9:454-459, 1989.
5. Boyle MJ, Gawley WF, Hickey DP, Drumm J, Murphy DM, Hanson JS,
Glacken P: Experience using the Quinton Permcath for haemodialysis
in the Irish Republic. Nephrol Dial Transplant 12:1934-1939, 1997.
6. Randolph AG, Cook DJ, Gonzales CA, Pribble CG: Ultrasound
guidance for placement of central venous catheters: a meta-analysis
of the literature. Crit Care Med 24:2053-2058, 1996.
7. Arnold WP: Improvement in hemodialysis vascular access outcomes
in a dedicated access center. Semin Dial 13:359-363, 2000.
8. Wivell W, Bettmann MA, Baxter B, Langdon DR, Remilliard B,
Chobanian M: Outcomes and performance of the Tesio twin catheter
system placed for hemodialysis access. Radiology 221:697-703, 2001.
9. Lund GB, Trerotola SO, Scheel PF Jr, Savader SJ, Mitchell SE,
Venbrux AC, Osterman FA Jr: Outcome of tunneled hemodialysis
catheters placed by radiologists. Radiology 198:467-472, 1996.
10. Trerotola SO, Johnson MS, Harris VJ, Shah H, Ambrosius WT,
McKusky MA, Kraus MA: Outcome of tunneled hemodialysis catheters
placed via the right internal jugular vein by interventional
radiologists. Radiology 203:489-495, 1997.
11. Prabhu PN, Kerns SR, Sabatelli FW, Hawkins IF, Ross EA: Long-
term performance and complications of the Tesio twin catheter system
for hemodialysis access. Am J Kidney Dis 30:213-218, 1997.
12. Schnabel KJ, Simons ME, Zevallos GF, Pron GE, Fenton SS,
Sniderman KW, Vanderburgh LC: Image-guided insertion of the Uldall
tunneled hemodialysis catheter: technical success and clinical
follow-up. J Vasc Interv Radiol 8:579-586, 1997.
13. Nassar GM, Ayus JC: Infectious complications of the hemodialysis
[[Page 36955]]
access. Kidney Int 60:1-13, 2001 (1990s data).
14. Power A, Singh SK, Ashby D, Cairns T, Taube D, Duncan N: Long-
term Tesio catheter access for hemodialysis can deliver high
dialysis adequacy with low complication rates. J Vasc Interv Radiol
22:631-637, 2011.
15. Duncan ND, Singh S, Cairns TD, Clark M, El-Tayar A, Griffith M,
Hakim N, Hamady M, McLean AG, Papalois V, Palmer A, Taube D: Tesio-
Caths provide effective and safe long-term vascular access. Nephrol
Dial Transplant 19:2816-2822, 2004.
16. Eisenstein I, Tarabeih M, Magen D, Pollack S, Kassis I, Ofer A,
Engel A, Zelikovic I: Low infection rates and prolonged survival
times of hemodialysis catheters in infants and children. Clin J Am
Soc Nephrol 6:793-798, 2011.
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, it is
proposed that 21 CFR part 876 be amended as follows:
PART 876--GASTROENTEROLOGY--UROLOGY DEVICES
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.
2. Section 876.5540 is amended by revising paragraphs (a)(1),
(a)(2), and (b)(1) and by removing paragraph (c) to read as follows:
Sec. 876.5540 Blood access device and accessories.
(a) * * *
(1) The implanted blood access device consists of various flexible
or rigid tubes, such as catheters, or cannulae, which are surgically
implanted in appropriate blood vessels, may come through the skin, and
are intended to remain in the body for 30 days or more. This generic
type of device includes: Single, double, and triple lumen catheters
with cuffs, subcutaneous ports with catheters, shunts, cannula, vessel
tips, and connectors specifically designed to provide access to blood.
(2) The nonimplanted blood access device consists of various
flexible or rigid tubes, such as catheters, cannulae or hollow needles,
which are inserted into appropriate blood vessels or a vascular graft
prosthesis (Sec. Sec. 870.3450 and 870.3460), and are intended to
remain in the body for less than 30 days. This generic type of device
includes noncuffed catheters, fistula needles, single dialysis needles
(coaxial flow needle), and the single needle dialysis set (alternating
flow needle).
* * * * *
(b) Classification. (1) Class II (special controls) for the
implanted blood access device. The special control for this device is
FDA's ``Class II Special Controls Guidance Document: Implanted Blood
Access Devices for Hemodialysis.''
* * * * *
Dated: June 15, 2012.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2012-15024 Filed 6-19-12; 8:45 am]
BILLING CODE 4160-01-P