Federal Register / Vol. 72, No. 38 / Tuesday, February 27, 2007 / Notices 8757 

is safe and effective for its intended uses 

or is safe for use.) The draft guidance 

makes the following two fundamental 

points: 

• First, depending on the CAM 

therapy or practice, a product used in a 

CAM therapy or practice may be subject 

to regulation as a biological product, 

cosmetic, drug, device, or food 

(including food additives and dietary 

supplements) under the act or the PHS 

Act. 

• Second, neither the act nor the PHS 

Act exempts CAM products from 

regulation. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on the regulation of complementary and 

alternative medicine products by FDA. 

It does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/ohrms/dockets/ 

default.htm. 

Dated: December 6, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–3259 Filed 2–26–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0020] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; Class II 

Special Controls Guidance Document; 

Oxygen Pressure Regulators and 

Oxygen Conserving Devices; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry and FDA staff entitled ‘‘Class II 

Special Controls Guidance Document: 

Oxygen Pressure Regulators and Oxygen 

Conserving Devices.’’ The draft 

guidance document is intended to assist 

manufacturers in complying with 

minimum performance, testing, and 

labeling recommendations that are being 

proposed for these devices. Elsewhere 

in this issue of the Federal Register, 

FDA is publishing a proposed rule to 

reclassify pressure regulators for use 

with medical oxygen into class II, 

subject to special controls. The proposal 

would also establish separate 

identification classifications for both 

oxygen pressure regulators and oxygen 

conserving devices, and would make 

those oxygen conserving devices that 

incorporate a built-in oxygen pressure 

regulator subject to special controls. 

This draft guidance is not final nor is it 

in effect at this time. 

DATES: Submit written or electronic 

comments on the draft guidance by May 

29, 2007. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Class II Special 

Controls Guidance Document: Oxygen 

Pressure Regulators and Oxygen 

Conserving Devices’’ to the Division of 

Small Manufacturers, International, and 

Consumer Assistance (HFZ–220), Center 

for Devices and Radiological Health, 

Food and Drug Administration, 1350 

Piccard Dr., Rockville, MD 20850. Send 

two self-addressed adhesive labels to 

assist that office in processing your 

request, or fax your request to 1–800–

638–2041. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

101, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Christy Foreman, Center for Devices and 

Radiological Health (HFZ–340), Food 

and Drug Administration, 2094 Gaither 

Rd., Rockville, MD 20850, 240–276–

0120. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This draft guidance provides FDA’s 

recommendations to manufacturers for 

labeling and for determining ignition 

sensitivity and fault tolerance for 

oxygen pressure regulators. These 

devices are intended to convert medical 

oxygen pressure from a high variable 

pressure to a lower, more constant 

working pressure. The device is affixed 

to a pressurized container of oxygen and 

the regulator controls the gas flow. 

These devices are currently regulated as 

class I devices. However, FDA has 

received reports of fires and explosions 

associated with the use of oxygen 

pressure regulators resulting in serious 

injury to a number of equipment 

operators, including one fatality. The 

draft guidance, if finalized, would serve 

as the special control for these devices. 

FDA believes that conformance with the 

draft special controls guidance, when 

combined with the general controls of 

the Federal Food, Drug, and Cosmetic 

Act (the act), would address the risks 

associated with oxygen pressure 

regulators and provide reasonable 

assurance of their safety and 

effectiveness. 

The draft guidance would also serve 

as a special control for oxygen 

conserving devices with a built-in 

oxygen pressure regulator; a device type 

already classified into class II under the 

generic device type noncontinuous 

ventilator (21 CFR 868.5905). FDA 

believes that conformance with the draft 

special controls guidance, when 

combined with the general controls of 

the act, will provide reasonable 

assurance of the safety and effectiveness 

of oxygen conserving devices with a 

built-in oxygen pressure regulator. 

In the Federal Register of May 27, 

2003 (68 FR 30214), FDA announced its 

intention to reclassify oxygen pressure 

regulators in its semi-annual regulatory 

agenda. FDA received one comment 

supporting the establishment of a 

proposed rule to reclassify these 

devices. 


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8758 Federal Register / Vol. 72, No. 38 / Tuesday, February 27, 2007 / Notices 

II. Significance of the Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on oxygen pressure regulators and 

oxygen conserving devices with a builtin oxygen pressure regulator. It does not 

create or confer any rights for or on any 

person and would not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statute and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by using 

the Internet. To receive ‘‘Class II Special 

Controls Guidance Document: Pressure 

Regulators For Use With Medical 

Oxygen and Oxygen Conserving 

Devices,’’ you may either send an e-mail 

request to dsmica@fda.hhs.gov to 

receive an electronic copy of the 

document, or send a fax request to 240–

276–3151 to receive a hard copy. Please 

use the document number 1227 to 

identify the guidance you are 

requesting. 

CDRH maintains an entry on the 

Internet for easy access to information 

including text, graphics, and files that 

may be downloaded to a personal 

computer with Internet access. Updated 

on a regular basis, the CDRH home page 

includes device safety alerts, Federal 

Register reprints, information on 

premarket submissions (including lists 

of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http://www.fda.gov/ 

ohrms/dockets. 

IV. Paperwork Reduction Act of 1995 

This draft guidance 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 

(the PRA) (44 U.S.C. 3501–3520). The 

collections of information in 21 CFR 

part 807, subpart E (premarket 

notification procedures) have been 

approved under OMB Control number 

0910–0120. The labeling statements that 

would be required by this regulation are 

‘‘public disclosure[s] of information 

originally supplied by the Federal 

government to the recipient for the 

purpose of disclosure to the public 

* * *’’ (5 CFR 1320.3(c)(2)). 

Accordingly, FDA concludes that the 

labeling requirements in this proposed 

rule are not subject to review by OMB 

under the PRA. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. The draft 

guidance and received comments may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: February 8, 2007. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. E7–3254 Filed 2–26–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to Office of Management 

and Budget under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, call the 

HRSA Reports Clearance Officer on 

(301) 443–1129. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: The Nurse Faculty 

Loan Program (NFLP): Annual 

Operating Report (AOR) Form—NEW 

Under Title VIII of the Public Health 

Service Act, as amended by Public Law 

107–205, Section 846A, the Secretary of 

Health and Human Services (HHS) 

enters into an agreement with a school 

of nursing to establish and operate the 

NFLP fund. HHS makes an award to the 

school in the form of a Federal Capital 

Contribution (FCC). The award is used 

to establish a distinct account for the 

NFLP loan fund at the school or is 

deposited into an existing NFLP fund. 

The school of nursing makes loans from 

the NFLP fund to eligible students 

enrolled full-time in a master’s or 

doctoral nursing education program that 

will prepare them to become qualified 

nursing faculty. Following graduation 

from the NFLP lending school, loan 

recipients may receive up to 85 percent 

NFLP loan cancellation over a 

consecutive four-year period in 

exchange for service as full-time faculty 

at a school of nursing. The NFLP 

lending school collects any portion of 

the loan that is not cancelled and any 

loan in repayment and deposits these 

monies into the NFLP loan fund to make 

additional NFLP loans. The school of 

nursing must keep records of all NFLP 

loan fund transactions. 

The NFLP Annual Operating Report 

will be used to collect information 

relating to the NFLP loan fund 

operations and financial activities for a 

specified reporting period (July 1 

through June 30 of the academic year). 

Participating schools will complete and 

submit the AOR annually to provide the 

Federal Government with current and 

cumulative information on: (1) The 

number and amount of loans made, (2) 

the number of NFLP recipients and 

graduates, (3) the number and amount of 

loans collected, (4) the number and 

amount of loans in repayment, (5) the 

number of NFLP graduates employed as 

nurse faculty, (6) NFLP loan fund 

receipts, disbursements and other 

related cost. The NFLP loan fund 

balance is used to determine future 

awards to the school. 


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