44748 Federal Register / Vol. 73, No. 148 / Thursday, July 31, 2008 / Notices 

FOR FURTHER INFORMATION CONTACT: 

Sandra M. Peay, Contact Representative 

or Renee Hallman, Contact 

Representative, Federal Trade 

Commission, Premerger Notification 

Office, Bureau of Competition, Room H–

303, Washington, DC 20580, (202) 326–

3100. 

By Direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. E8–17416 Filed 7–30–08; 8:45 am] 

BILLING CODE 6750–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0146] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Requirements for 

Collection of Data Relating to the 

Prevention of Medical Gas Mix-ups at 

Health Care Facilities-Survey 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by September 

2, 2008. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

baguilar@omb.eop.gov. All comments 

should be identified with the OMB 

control number 0910–0548. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Requirements for Collection of Data 

Relating to the Prevention of Medical 

Gas Mix-ups at Health Care FacilitiesSurvey—(OMB Control Number 0910–

0548)—Extension 

On March 7, 2008 (73 FR 12452) and 

July 1, 2008 (73 FR 37465) respectively, 

FDA published a 60–day and 30–day 

notice stating that it had received 4 

reports of medical gas mix-ups 

occurring during the past 9 years which 

involved 7 deaths and 15 injuries to 

patients who were thought to be 

receiving medical grade oxygen, but 

who were actually receiving a different 

gas (e.g., nitrogen, argon) that had been 

mistakenly connected to the facility’s 

oxygen supply system. These reported 

incidents actually occurred between 

1998 and 2000 which, at the time, 

prompted the FDA in 2001 to publish 

guidance making recommendations to 

help hospitals, nursing homes, and 

other health care facilities avoid the 

tragedies that result from medical gas 

mix-ups and alerting these facilities to 

the hazards. This survey is intended to 

assess the degree of facilities’

compliance with safety measures to 

prevent mix-ups, to determine if further 

steps are warranted to ensure the safety 

of patients. 

In the Federal Register of March 7, 

2008 (73 FR 12452), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR section No. of 

respondents 

Annual frequency 

per response 

Total annual 

responses 

Hours per 

response Total hours 

210 and 211 285 1 285 .25 71.25 

Total 285 1 285 .25 71.25 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 148 / Thursday, July 31, 2008 / Notices 44749 

Dated: July 25, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–17566 Filed 7–30–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0094] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Channels of Trade Policy for 

Commodities With Residues of 

Pesticide Chemicals, for Which 

Tolerances Have Been Revoked, 

Suspended, or Modified by the 

Environmental Protection Agency 

Pursuant to Dietary Risk 

Considerations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Channels of Trade Policy for 

Commodities With Residues of Pesticide 

Chemicals, for Which Tolerances Have 

Been Revoked, Suspended, or Modified 

by the Environmental Protection Agency 

Pursuant to Dietary Risk 

Considerations’’ has been approved by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of May 16, 2008 (73 FR 

28484), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0562. The 

approval expires on July 31, 2011. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: July 25, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–17576 Filed 7–30–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0047] (formerly 

Docket No. 2008N–0005) 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Formal Dispute 

Resolution: Scientific and Technical 

Issues Related to Pharmaceutical 

Current Good Manufacturing Practice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by September 

2, 2008. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

baguilar@omb.eop.gov. All comments 

should be identified with the OMB 

control number 0910–0563. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Formal Dispute Resolution: Scientific 

and Technical Issues Related to 

Pharmaceutical Current Good 

Manufacturing Practice—(OMB Control 

Number 0910–0563)—Extension 

The guidance is intended to provide 

information to manufacturers of 

veterinary and human drugs, including 

human biological drug products, on 

how to resolve disputes of scientific and 

technical issues relating to Current 

Good Manufacturing Practice (CGMP). 

Disputes related to scientific and 

technical issues may arise during FDA 

inspections of pharmaceutical 

manufacturers to determine compliance 

with CGMP requirements, or during 

FDA’s assessment of corrective actions 

undertaken as a result of such 

inspections. The guidance provides 

procedures that encourage open and 

prompt discussion of disputes and lead 

to their resolution. The guidance 

describes procedures for raising such 

disputes to the Office of Regulatory 

Affairs (ORA) and center levels and for 

requesting review by the dispute 

resolution (DR) Panel (the DR Panel). 

When a scientific or technical issue 

arises during an FDA inspection, the 

manufacturer should initially attempt to 

reach agreement on the issue informally 

with the investigator. Certain scientific 

or technical issues may be too complex 

or time-consuming to resolve during the 

inspection. If resolution of a scientific or 

technical issue is not accomplished 

through informal mechanisms prior to 

the issuance of Form FDA 483, the 

manufacturer can formally request DR 

and can use the formal two-tiered DR 

process described in the guidance. 

Tier-one of the formal DR process 

involves scientific or technical issues 

raised by a manufacturer to the ORA 

and center levels. If a manufacturer 

disagrees with the tier-one decision, tier 

two of the formal DR process would 

then be available for appealing that 

decision to the DR Panel. 

The written request for formal DR to 

the appropriate ORA unit should be 

made within 30 days of the completion 

of an inspection, and should include all 

supporting documentation and 

arguments for review, as described 

below. The written request for formal 

DR to the DR Panel should be made 

within 60 days of receipt of the tier-one 

decision, and should include all 

supporting documentation and 

arguments, as described in the following 

paragraphs. 

All requests for formal DR should be 

in writing and include adequate 

information to explain the nature of the 

dispute and to allow FDA to act quickly 

and efficiently. Each request should be 

sent to the appropriate address listed in 

the guidance and include the following: 

• Cover sheet that clearly identifies 

the submission as either a request for 

tier-one DR or a request for tier-two DR; 

• Name and address of manufacturer 

inspected (from Form FDA 483); 


jlentini on PROD1PC65 with NOTICES