11586 Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / Notices 

INA 412(c)(1)(B) states that formula 

funds shall be allocated based on the 

total number of refugees, taking into 

account secondary migration. 

In order to meet the statutory 

requirements, ORR requires each state to 

submit disaggregated individual records 

containing certain data elements for 

eligible refugee populations. This 

revised collection differs from the ORR– 

11 Refugee State-of-Origin Report 

process, whereby states submitted the 

ORR–11 form containing aggregate data 

on the number of refugees and entrants 

served whose ‘‘area numbers’’ (the first 

three digits of the social security 

number) fell into each of several 

designated numerical ranges. ORR used 

the information on the ORR–11 to 

measure secondary migration for the 

purposes of formula funds allocation to 

states. The revision is proposed due to 

the realization that: 

(1) The Social Security 

Administration states that the first three 

digits of social security numbers (area 

number) should not be used for any 

other purpose than as an individual 

identifier for book-keeping purposes. 

(2) It is possible for individuals to 

apply for Social Security Numbers from 

any Social Security office, not just 

offices in the state in which they were 

born or first resided. This is particularly 

likely in metropolitan statistical areas 

where individuals may live in one of 

several states (e.g., the Washington 

Metropolitan Area). In these cases, the 

area number of the Social Security 

Number may be unreliable as a measure 

of refugees’ state of initial resettlement. 

(3) In recent years, the Social Security 

Administration has begun to issue 

Social Security Numbers whose area 

number is not connected to any specific 

state. 

The submission of individual records 

via the Refugee Data Submission System 

for Formula Funds Allocations Web site 

is a more reliable and secure process for 

collecting data for the purposes of 

tracking secondary migration and 

allocating formula funds. Data 

submitted by the States via the secure 

Web site are compiled and analyzed by 

the ORR statistician for the purpose of 

refugee secondary services formula 

funds allocation. The statistician also 

prepares a summary report, which is 

included in ORR’s Annual Report to 

Congress. 

Respondents: States and the District 

of Columbia. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Refugee Data Submission for Formula Funds Allocations ............................. 50 1 20 1,000 

Estimated Total Annual Burden 

Hours: 1,000. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project. 

Fax: 202–395–6974. 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: March 13, 2009. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E9–5814 Filed 3–17–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0451] 

Food and Drug Administration 

Modernization Act of 1997: 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

021 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

publication containing modifications 

the agency is making to the list of 

standards FDA recognizes for use in 

premarket reviews (FDA recognized 

consensus standards). This publication, 

entitled ‘‘Modifications to the List of 

Recognized Standards, Recognition List 

Number: 021’’ (Recognition List 

Number: 021), will assist manufacturers 

who elect to declare conformity with 

consensus standards to meet certain 

requirements for medical devices. 

DATES: Submit written or electronic 

comments concerning this document at 

any time. See section VII of this 

document for the effective date of the 

recognition of standards announced in 

this document. 

ADDRESSES: Submit written requests for 

single copies of ‘‘Modifications to the 

List of Recognized Standards, 

Recognition List Number: 021’’ to the 

Division of Small Manufacturers, 

International and Consumer Assistance, 

Center for Devices and Radiological 

Health (HFZ–220), Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that 

office in processing your requests, or fax 

your request to 240–276–3151. Submit 

written comments concerning this 

document, or recommendations for 

additional standards for recognition, to 

the contact person (see FOR FURTHER

INFORMATION CONTACT). Submit 

electronic comments by e-mail: 

standards@cdrh.fda.gov. This document 

may also be accessed on FDA’s Internet 

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

scripts/cdrh/cfdocs/cfTopic/ 

cdrhnew.cfm. See section VI of this 

document for electronic access to the 

searchable database for the current list 

of FDA recognized consensus standards, 

including Recognition List Number: 021 

modifications and other standards 

related information. 

FOR FURTHER INFORMATION CONTACT: 

Carol L. Herman, Center for Devices and 

Radiological Health (HFZ–84), Food and 

Drug Administration, 7520 Standish 

Place, Rockville, MD 20855, 240–276– 

8714. 


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Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / Notices 11587 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 204 of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Public Law 105–115) 

amended section 514 of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 360d). Amended section 514 

allows FDA to recognize consensus 

standards developed by international 

and national organizations for use in 

satisfying portions of device premarket 

review submissions or other 

requirements. 

In a notice published in the Federal 

Register of February 25, 1998 (63 FR 

9561), FDA announced the availability 

of a guidance entitled ‘‘Recognition and 

Use of Consensus Standards.’’ The 

notice described how FDA would 

implement its standard recognition 

program and provided the initial list of 

recognized standards. 

Modifications to the initial list of 

recognized standards, as published in 

the Federal Register, are identified in 

table 1. 

TABLE 1—FEDERAL REGISTER CITATION

October 16, 1998 (63 FR 55617) May 27, 2005 (70 FR 30756) 

July 12, 1999 (64 FR 37546) November 8, 2005 (70 FR 67713) 

November 15, 2000 (65 FR 69022) March 31, 2006 (71 FR 16313) 

May 7, 2001 (66 FR 23032) June 23, 2006 (71 FR 36121) 

January 14, 2002 (67 FR 1774) November 3, 2006 (71 FR 64718) 

October 2, 2002 (67 FR 61893) May 21, 2007 (72 FR 28500) 

April 28, 2003 (68 FR 22391) September 12, 2007 (72 FR 52142) 

March 8, 2004 (69 FR 10712) December 19, 2007 (72 FR 71924) 

June 18, 2004 (69 FR 34176) September 9, 2008 (73 FR 52358) 

October 4, 2004 (69 FR 59240) 

These notices describe the addition, 

withdrawal, and revision of certain 

standards recognized by FDA. The 

agency maintains ‘‘hypertext markup 

language (HTML)’’ and ‘‘portable 

document format (PDF)’’ versions of the 

list of ‘‘FDA Recognized Consensus 

Standards.’’ Both versions are publicly 

accessible at the agency’s Internet site. 

See section VI of this document for 

electronic access information. Interested 

persons should review the 

supplementary information sheet for the 

standard to understand fully the extent 

to which FDA recognizes the standard. 

II. Modifications to the List of 

Recognized Standards, Recognition List 

Number: 021 

FDA is announcing the addition, 

withdrawal, correction, and revision of 

certain consensus standards the agency 

will recognize for use in satisfying 

premarket reviews and other 

requirements for devices. FDA will 

incorporate these modifications in the 

list of FDA Recognized Consensus 

Standards in the agency’s searchable 

database. FDA will use the term 

‘‘Recognition List Number: 021’’ to 

identify these current modifications. 

In table 2 of this document, FDA 

describes the following modifications: 

(1) The withdrawal of standards and 

their replacement by others; (2) the 

correction of errors made by FDA in 

listing previously recognized standards; 

and (3) the changes to the 

supplementary information sheets of 

recognized standards that describe 

revisions to the applicability of the 

standards. 

In section III of this document, FDA 

lists modifications the agency is making 

that involve the initial addition of 

standards not previously recognized by 

FDA. 

TABLE 2 

Old Recognition 

No. 

Replacement 

Recognition 

No. 

Standard Change 

A. Anesthesia 

1–49 ASTM F 1981–99 Standard Specification for Suction Catheters for use in 

the Respiratory Tract 

Withdrawn 

1–63 1–77 CGA V–1:2005 Standard for Compressed Gas Cylinder Valve Outlet and 

Inlet Connection 

Withdrawn and replaced with 

newer version 

1–64 1–78 ASME PVHO–1–2007 Safety Standard for Pressure Vessels for Human 

Occupancy 

Withdrawn and replaced with 

newer version 


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TABLE 2—Continued 

Old Recognition 

No. 

Replacement 

Recognition 

No. 

Standard Change 

1–71 ISO 10651–5:2006 Lung Ventilators for Medical Use—Particular requirements for Basic Safety and Essential Performance—Part 5: Gas-powered 

Emergency Resuscitators 

Withdrawn duplicate 

1–74 ISO 5360:2006 Anaesthetic Vaporizers—Agent Specific Filling Systems Contact person 

1–76 1–79 ISO 26825:2008 (E) Anaesthetic And Respiratory Equipment—User-Applied 

Labels For Syringes Containing Drugs Used During Anaesthesia—Colours, Design and Performance 

Withdrawn and replaced with 

newer version 

B. Biocompatibility 

2–71 2–133 ASTM F1408–97 (2008) Standard Practice for Subcutaneous Screening 

Test for Implant Materials 

Withdrawn and replaced with 

newer version 

2–73 2–134 ASTM F2065–00(2006) Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials Withdrawn and replaced with 

newer version 

2–87 AAMI/ANSI/ISO 10993–10:2002 Biological Evaluation of Medical Devices— 

Part 10: Tests for Irritation and Delayed-Type Hypersensitivity 

Extent of Recognition, Relevant Guidance, and Contact Person 

2–88 2–135 AAMI/ANSI/ISO 10993–12:2007 Biological Evaluation of Medical Devices— 

Part 12: Sample Preparation and Reference Materials 

Withdrawn and replaced with 

newer version 

2–127 ANSI/AAMI BE 78:2002/A1:2006 Biological Evaluation of Medical Devices—Part 10: Tests For Irritation and Delayed-Type Hypersensitivity— 

Amendment 1 

Withdrawn 

C. Cardiovascular/Neurology 

3–67 ASTM F2129–06 Standard Test Method for Conducting Cyclic 

Potentiodynamic Polarization Measurements to Determine the Corrosion 

Susceptibility of Small Implant Devices 

Offices, Devices Affected, 

Relevant Guidance, CFR 

Citation and Product 

Codes, Contact Person 

D. General Hospital/General Plastic Surgery 

6–29 IEC 60601–2–19 1996–10: Amendment 1—Medical Electrical Equipment 

Part 2: Particular Requirements for Safety of Baby Incubators 

Relevant guidance 

6–32 IEC 60601–2–20 1996–10: Amendment 1—Medical Electrical Equipment 

Part 2: Particular Requirements for the Safety Of Transport Incubators 

Relevant guidance 

6–62 ISO 8536–6:1995 Infusion Equipment for Medical Use—Part 6: Freeze Drying Closures for Infusion Bottles Relevant guidance 

6–63 ISO 8536–7–1999: Infusion Equipment for Medical Use—Part 7: Caps 

Made of Aluminum-Plastics Combinations For Infusion Bottles 

Relevant guidance 

6–64 ISO 8536–3–1999, Infusion Equipment for Medical Use—Part 3: Aluminum 

Caps for Infusion Bottles 

Relevant guidance 

6–119 ANSI/AAMI BF7:1989/(R)2002/(R)2007 Blood Transfusion Micro-Filters Reaffirmation 2007, Title, 

SDO, Date of standard, 

Relevant guidance 

6–122 ISO 8536–5–2004:, Infusion Equipment for Medical Use—Part 5: Burette 

Infusion Sets for Single Use, Gravity Feed 

Relevant guidance 

6–127 ISO 1135–4–2004: Transfusion Equipment for Medical Use—Part 4: Transfusion Sets for Single Use Relevant guidance 

6–142 ANSI/AAMI II36:2004 Medical Electrical Equipment—Part 2: Particular Requirements for Safety of Baby Incubators Title, Relevant guidance 

6–143 ANSI/AAMI II51:2004, Medical Electrical Equipment—Part 2: Particular Requirements for Safety of Transport Incubators Title, Relevant guidance 


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TABLE 2—Continued 

Old Recognition 

No. 

Replacement 

Recognition 

No. 

Standard Change 

6–172 ISO 8536–1:2006 Infusion Equipment for Medical Use—Part 1: Infusion 

Glass Bottles 

Relevant guidance 

6–173 ISO 8536–2:2001 Corrigendum 1:2003, Infusion Equipment for Medical 

Use—Part 2: Closures for Infusion Bottles 

Relevant guidance 

6–182 IEC 60601–2–38 1996/Amendment 1:1999, Medical Electrical Equipment— 

Part 2–38: Particular Requirements for the Safety of Electrically Operated 

Hospital Beds 

Relevant guidance 

6–201 ISO 8536–4:2007 Infusion Equipment for Medical Use—Part 4: Infusion 

Sets for Single Use, Gravity Feed 

Relevant guidance 

6–215 ASTM F2132–01(2008)E1 Standard Specification for Puncture Resistance 

of Materials Used in Containers for Discarded Medical Needles and 

Other Sharps 

Title 

E. IVD 

7–138 7–169 CLSI M27–A3 Reference Method for Broth Dilution Antifungal Susceptibility 

Testing of Yeasts 

Withdrawn and replaced with 

newer version 

7–54 CLSI D12–A2, Immunoprecipitin Analyses: Procedures for Evaluating the 

Performance of Materials—Second Edition; Approved Guideline 

Title 

7–71 CLSI H15–A3, Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard—Third Edition Contact person 

7–145 CLSI H42–A2, Enumeration of Immunologically Defined Cell Populations by 

Flow Cytometry. 

Contact person 

7–73 7–170 CLSI ILA21–A2 Clinical Evaluation of Immunoassays Withdrawn and replaced with 

newer version 

7–130 CLSI H20–A2, Reference Leucocyte Differential Count (Proportional) and 

Evaluation of Instrumental Methods; Approved Standard—Second Edition 

Contact person 

7–164 CLSI GP 28–A Microwave Device Use in the Histology Laboratory; Approved Guideline Contact person 

7–168 7–171 CLSI M38–A2 Reference Method for Broth Dilution Antifungal Susceptibility 

Testing of Filamentous Fungi 

Withdrawn and replaced with 

newer version 

F. Neurology 

3–3 17–1 AAMI NS28:1988/(R) 2006 Intracranial Pressure Monitoring Devices Transferred, Date of standard, 

Extent of recognition, Relevant guidance 

3–32 17–2 ASTM F1542–94(2000) Standard Specification for the Requirements and 

Disclosure of Self-Closing Aneurysm Clips 

Transferred, Offices, Type of 

standard, Extent of recognition, Relevant guidance, 

Contact person 

3–33 17–3 ISO 7197:2006 Neurosurgical implants—Sterile, Single-use hydrocephalus 

Shunts and Components 

Transferred—Withdrawn and 

replaced with newer version 

3–39 17–4 ASTM F647–94(2006) Standard Practice for Evaluating and Specifying 

Implantable Shunt Assemblies for Neurosurgical Application 

Transferred—Withdrawn and 

replaced with newer version 

3–60 17–5 IEC 60601–2–10 1987/Amendment 1 2001 Medical Electrical Equipment— 

Part 2–10: Particular Requirements for the Safety of Nerve and Muscle 

Stimulators 

Transferred, Title change, 

Date of standard, Relevant 

guidance, Contact person 

3–67 17–6 ASTM F2129–06 Standard Test Method for Conducting Cyclic 

Potentiodynamic Polarization Measurements to Determine the Corrosion 

Susceptibility of Small Implant Devices 

Offices, Devices affected, 

Type of Standard, Product 

code, Relevant guidance, 

Contact person 

G. OB-GYN/Gastroenterology 


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11590 Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / Notices 

TABLE 2—Continued 

Old Recognition 

No. 

Replacement 

Recognition 

No. 

Standard Change 

9–30 9–55 ANSI/ AAMI RD62:2006 Water Treatment Equipment for Hemodialysis Applications Withdrawn and replaced with 

newer version 

9–32 9–56 ASTM D3492–08 Standard Specification for Rubber Contraceptives (Male 

Condoms) 

Withdrawn and replaced with 

newer version 

9–34 ISO 4074:2002/Cor.1:2003(E): Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 1 Extent of recognition, Product 

codes, Relevant guidance 

H. Radiology 

12–48 AIUM AOL, Acoustic Output Labeling Standard for Diagnostic Ultrasound 

Equipment: A Standard for How Manufacturers Should Specify Acoustic 

Output Data 

Relevant guidance 

12–55 12–186 IEC 60601–2–29 (2008) Medical Electrical Equipment—Part 2–29: Particular Requirements for the Basic Safety and Essential Performance of 

Radiotherapy Simulators—Third Edition 

Withdrawn and replaced with 

newer version 

12–66 AIUM MUS, Medical Ultrasound Safety Relevant guidance 

12–96 12–187 NEMA MS 3–2008 Determination of Image Uniformity in Diagnostic Magnetic Resonance Images Withdrawn and replaced with 

newer version 

12–97 12–188 NEMA MS 1–2008 Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging Withdrawn and replaced with 

newer version 

12–100 NEMA UD 3–2004, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Relevant guidance 

12–105 NEMA UD 2–2004, Acoustic Output Measurement Standard for Diagnostic 

Ultrasound Equipment Version 3 

Title, Relevant guidance 

12–139 AIUM AOMS–2005, Acoustic Output Measurement Standard for Diagnostic 

Ultrasound Equipment 

Relevant guidance 

12–140 AIUM RTD1–2005, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment 

Revision 1 

Relevant guidance 

12–161 12–189 IEC 60601–2–33 (2008) Medical Electrical Equipment—Part 2–33: Particular Requirements for the Safety of Magnetic Resonance Equipment 

for Medical Diagnosis Consolidated Edition 2.2 

Withdrawn and replaced with 

a newer version 

12–182 IEC 60601–2–37:2007, Medical Electrical Equipment—Part 2–37: Particular 

Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment 

Relevant guidance 

12–184 12–190 IEC 61217 (2008) Radiotherapy Equipment—Coordinates, Movements, and 

Scales Consolidated Edition 1.2 

Withdrawn and replaced with 

newer version 

I. Sterility 

14–120 14–257 ASTM D3078—02(2008) Standard Test Method for Determination of Leaks 

in Flexible Packaging by Bubble Emission 

Withdrawn and replaced with 

newer version 

14–148 14–258 ASTM F2250—03(2008) Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials Withdrawn and replaced with 

newer version 

14–149 14–259 ASTM F2251—03(2008) Standard Test Method for Thickness Measurement 

of Flexible Packaging Material 

Withdrawn and replaced with 

newer version 

14–150 14–260 ASTM F2252—03(2008) Standard Practice for Evaluating Ink or Coating 

Adhesion to Flexible Packaging Materials Using Tape 

Withdrawn and replaced with 

newer version 

J. Tissue Engineering 

15–11 15–13 ASTM F2212–02(2008)e1, Standard Guide for Characterization of Type I 

Collagen as a Starting Material for Surgical Implants and Substrates for 

Tissue Engineered Medical Products 

Withdrawn and replaced with 

newer version 


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III. Listing of New Entries 

In table 3 of this document, FDA 

provides the listing of new entries and 

consensus standards added as 

modifications to the list of recognized 

standards under Recognition List 

Number: 021. 

TABLE 3 

Recognition No. Title of Standard Reference No. & Date 

A. Dental/ENT 

4–160 Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms ANSI ASA S3.1–1999 (R 

2003) 

4–161 Method for Measuring the Intelligibility of Speech Over Communication Systems ANSI ASA S3.2–1989 (R 

1999) 

4–162 Procedure for the Computation of Loudness of Steady Sounds ANSI ASA S3.4–2007 

4–163 Methods for Calculation of the Speech Intelligibility Index ANSI ASA S3.5–1997 (R 

2007) 

4–164 Method for Coupler Calibration of Earphones ANSI ASA S3.7–1995 (R 

2003) 

4–165 Mechanical Coupler for Measurement of Bone Vibrators ANSI ASA S3.13–1987 (R 

2007) 

4–166 Bioacoustical Terminology ANSI ASA S3.20–1995 (R 

2003) 

4–167 Methods for Manual Pure-Tone Threshold Audiometry ANSI ASA S3.21–2004 

4–168 Occluded Ear Simulator ANSI ASA S3.25–1989 (R 

2003) 

4–169 Method of Measurement of Performance Characteristics of Hearing Aids under Simulated 

Real-Ear Working Conditions 

ANSI ASA S3.35–2004 

4–170 Specification for a Manikin for Simulated in situ Airborne Acoustic Measurements ANSI ASA S3.36–1985 (R 

2006) 

4–171 Preferred Earhook Nozzle Thread for Postauricular Hearing Aids ANSI ASA S3.37–1987 (R 

2007) 

4–172 Testing Hearing Aids with a Broad-Band Noise Signal ANSI ASA S3.42–1992 (R 

2007) 

4–173 Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing 

Impairment 

ANSI ASA S3.44–1996 (R 

2006) 

4–174 Procedures for Testing Basic Vestibular Function ANSI ASA S3.45–1999 

4–175 Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids ANSI ASA S3.46–1997 (R 

2002) 

4–176 Criteria for Evaluating Room Noise ANSI ASA S12.2–1995 (R 

1999) 

4–177 Rating Noise with Respect to Speech Interference ANSI ASA S12.65–2006 

B. General 

5–45 Standard Practice for Performance Testing of Packages for Single Delivery Systems ASTM D7386–08 

C. IVD 

7–172 Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory C28–P3 

7–173 Harmonization of Glycohemoglobin Measurements C44–A 

7–174 Estimation of Total Analytical Error for Clinical Laboratory EP21–A 

7–175 Apolipoprotein Immunoassays: Development and Recommended Performance Characteristics ILA15–A 

7–176 Immunoassay Interference by Endogenous Antibodies ILA30–A 


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TABLE 3—Continued 

Recognition No. Title of Standard Reference No. & Date 

7–177 Performance Standards for Antimicrobial Susceptibility Testing M100–S18 

7–178 Quality Control for Commercially Prepared Microbiological Culture Media M22–A3 

7–179 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts M27–S3 

7–180 Western Blot Assay for Antibodies to Borrelia burgdorferi M34–A 

7–181 Abbreviated Identification of Bacteria and Yeasts M35–A 

7–182 Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii M36–A 

7–183 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi M38–A2 

7–184 Quality Control of Microbiological Transport Systems M40–A 

7–185 Viral Culture M41–A 

7–186 Methods for Antifungal Disk Diffusion Susceptibility Testing M44–A 

7–187 Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration 

(MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion 

Susceptibility Testing of Yeast 

M44–S2 

7–188 Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or 

Fastidious Bacteria 

M45–A 

7–189 Principles and Procedures for Blood Cultures M47–A 

7–190 Quality Control for Commercial Microbial Identification Systems M50–A 

7–191 Collection, Transport, Preparation, and Storage of Specimens MM13–A 

7–192 Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing MM18–A 

7–193 Evaluation of the Linearity of Quantitative Measurement EP06–A 

7–194 Protocols for Determination of Limits of Detection and Limits of Quantitation EP17–A 

D. Neurology 

17–7 Neurosurgical implants—Sterile, Single-use Hydrocephalus Shunts and Components ISO 7197:2006/Technical 

Corrigendum1:2007 

E. OB-GYN/Gastroenterology 

9–57 Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 

2 

ISO 4074:2002/Cor.2:2008(E) 

F. Ophthalmic 

10–58 Laser Systems for Corneal Reshaping ANSI Z80.11–2007 

G. Radiology 

12–191 Ultrasonics—Field Characterization—Test Methods for the Determination of Thermal and 

Mechanical Indices Related to Medical Diagnostic Ultrasonic Fields 

IEC 62359:2005 

H. Software/Informatic 

13–25 Managing and Validating Laboratory Information Systems; Approved Guideline CLSI AUTO8–A 

13–26 Autoverification of Clinical Laboratory Test Results; Approved Guideline CLSI AUTO10–A 

13–27 IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard CLSI AUTO11–A 

13–28 Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved 

Standard 

CLSI AUTO9–A 

I. Sterility 

14–261 Sterilization of Health Care Products—Moist Heat—Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices ANSI/AAMI/ISO 17665– 

1:2006 


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IV. List of Recognized Standards 

FDA maintains the agency’s current 

list of FDA recognized consensus 

standards in a searchable database that 

may be accessed directly at FDA’s 

Internet site at http:// 

www.accessdata.fda.gov/scripts/cdrh/ 

cfdocs/cfStandards/search.cfm. FDA 

will incorporate the modifications and 

minor revisions described in this 

document into the database and, upon 

publication in the Federal Register, this 

recognition of consensus standards will 

be effective. FDA will announce 

additional modifications and minor 

revisions to the list of recognized 

consensus standards, as needed, in the 

Federal Register once a year, or more 

often, if necessary. 

V. Recommendation of Standards for 

Recognition by FDA 

Any person may recommend 

consensus standards as candidates for 

recognition under the new provision of 

section 514 of the act by submitting 

such recommendations, with reasons for 

the recommendation, to the contact 

person (See FOR FURTHER INFORMATION

CONTACT). To be properly considered 

such recommendations should contain, 

at a minimum, the following 

information: (1) Title of the standard; (2) 

any reference number and date; (3) 

name and address of the national or 

international standards development 

organization; (4) a proposed list of 

devices for which a declaration of 

conformity to this standard should 

routinely apply; and (5) a brief 

identification of the testing or 

performance or other characteristics of 

the device(s) that would be addressed 

by a declaration of conformity. 

VI. Electronic Access 

You may obtain a copy of ‘‘Guidance 

on the Recognition and Use of 

Consensus Standards’’ by using the 

Internet. CDRH maintains a site on the 

Internet for easy access to information 

including text, graphics, and files that 

you may download to a personal 

computer with access to the Internet. 

Updated on a regular basis, the CDRH 

home page includes the guidance as 

well as the current list of recognized 

standards and other standards related 

documents. After publication in the 

Federal Register, this document 

announcing ‘‘Modification to the List of 

Recognized Standards, Recognition List 

Number: 021’’ will be available on the 

CDRH home page. You may access the 

CDRH home page at http://www.fda.gov/ 

cdrh. 

You may access ‘‘Guidance on the 

Recognition and Use of Consensus 

Standards,’’ and the searchable database 

for ‘‘FDA Recognized Consensus 

Standards’’ through the hyperlink at 

http://www.fda.gov/cdrh/stdsprog.html. 

This Federal Register document on 

modifications in FDA’s recognition of 

consensus standards is available at 

http://www.fda.gov/cdrh/fedregin.html. 

VII. Submission of Comments and 

Effective Date 

Interested persons may submit to the 

contact person (see FOR FURTHER

INFORMATION CONTACT) written or 

electronic comments regarding this 

document. Two copies of any mailed 

comments are to be submitted, 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. FDA will consider any 

comments received in determining 

whether to amend the current listing of 

modifications to the list of recognized 

standards, Recognition List Number: 

021. These modifications to the list or 

recognized standards are effective upon 

publication of this document in the 

Federal Register. 

Dated: March 10, 2009. 

Daniel G. Schultz, 

Director, Center for Devices and Radiological 

Health. 

[FR Doc. E9–5858 Filed 3–17–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

In compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 concerning 

opportunity for public comment on 

proposed collections of information, the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

will publish periodic summaries of 

proposed projects. To request more 

information on the proposed projects or 

to obtain a copy of the information 

collection plans, call the SAMHSA 

Reports Clearance Officer on (240) 276– 

1243. 

Comments are invited on: (a) Whether 

the proposed collections of information 

are 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: National Evaluation 

of the Comprehensive Community 

Mental Health Services for Children and 

Their Families Program: Phase VI— 

NEW. 

The Substance Abuse and Mental 

Health Services Administration 

(SAMHSA), Center of Mental Health 

Services is responsible for the national 

evaluation of the Comprehensive 

Community Mental Health Services for 

Children and Their Families Program 

(Children’s Mental Health Initiative— 

CMHI) that will collect data on child 

mental health outcomes, family life, and 

service system development and 

performance. Data will be collected on 

26 service systems, and approximately 

5,541 children and families. 

Data collection for this evaluation will 

be conducted over a five-year period. 

Child and family outcomes of interest 

will be collected at intake and during 

subsequent follow-up sessions at sixmonth intervals. The length of time that 

individual families will participate in 

the study ranges from 12 to 24 months 

depending upon when they enter the 

evaluation. The outcome measures 

include the following: Child 

symptomatology and functioning, 

family functioning, satisfaction, and 

caregiver strain. The core of service 

system data will be collected every 18– 

24 months throughout the 5-year 

evaluation period, with a sustainability 

survey conducted in years 3 and 5. 

Service utilization and cost data will be 

tracked and submitted to the national 

evaluation every six months using two 

tools: The Flex Fund Tool and the 

Services and Costs Data Tool to estimate 

average cost of treatment per child, 

distribution of costs, and allocation of 

costs across service categories. Service 

delivery and system variables of interest 

include the following: Maturity of 

system of care development in funded 

system of care communities, adherence 

to the system of care program model, 

and client service experience. We will 

also conduct a comprehensive 

evaluation of the CMHI’s data driven 

technical assistance; this component of 

the evaluation will employ a mixedmethods approach, combining 

qualitative and quantitative data to 

provide a comprehensive assessment of 

the continuous quality improvement 

(CQI) process in funded system of care 


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