Federal Register / Vol. 74, No. 172 / Tuesday, September 8, 2009 / Notices 46203 

Drug Court Team Questionnaire 

This questionnaire will be 

administered to key drug court 

personnel (e.g., judge, drug court 

manager and treatment provider) during 

the three annual site visits to the drug 

court. This instrument consists of 15 

open-ended questions, and will ask 

respondents about their role and 

involvement in the drug court process, 

perceptions of drug courts, and the role 

of treatment and coercion in drug courts 

(subject to OMB approval). 

Drug Court Client Focus Group 

Questions for Guided Discussion 

Focus groups will be conducted 

during the annual site visits to each 

drug court. During the focus groups, 

drug court clients will be asked 12 

open-ended questions about their 

experiences in the drug court program 

and current efforts towards recovery. 

Drug court participants will be involved 

in focus groups on 1 to 3 occasions. 

Procedural Justice Questionnaire 

This instrument contains 13 items 

and asks drug court clients about their 

perceptions regarding fair treatment by 

the judge and drug court team during 

the drug court process. It is 

hypothesized that participants who 

perceive the judge and drug court team 

as fair will be more compliant with the 

drug court program, more likely to 

graduate, and have better substance use 

and criminal behavior outcomes (e.g., 

reduced substance use, fewer arrests). 

This questionnaire will be administered 

to drug court participants once, during 

the 6-month post-discharge interview. 

Correctional Mental Health Screener 

for Women 

A mental health screener for women 

(CMHS–W) will be administered to 

gather data on drug court participants’ 

mental health. Many drug court clients 

have co-occurring disorders (i.e., 

substance use and mental health 

disorders). The information gathered 

during this portion of the in-person drug 

court client interviews will provide a 

post-discharge indicator of mental 

health status and will be used as a 

moderator variable when assessing 

client outcomes such as drug use and 

arrest. This questionnaire will be 

administered to drug court participants 

once, during the 6-month post-discharge 

interview. The CMHS–W contains eight 

questions, and six items are common 

between the men and women’s versions 

of the instrument. 

Correctional Mental Health Screener 

for Men 

A mental health screener for men 

(CMHS–M) will be administered to 

gather data on drug court participants’ 

mental health. Many drug court clients 

have co-occurring disorders (i.e., 

substance use and mental health 

disorders). The information gathered 

during this portion of the in-person drug 

court client interviews will provide a 

post-discharge indicator of mental 

health status and will be used as a 

moderator variable when assessing 

client outcomes such as drug use and 

arrest. This questionnaire will be 

administered to drug court participants 

once, during the 6-month post-discharge 

interview. The CMHS–M contains 

twelve questions and the two 

instruments have six items in common. 

Treatment Satisfaction Index 

The Treatment Satisfaction Index will 

ask drug court participants about their 

satisfaction with treatment received 

during the drug court program. This 19- 

item questionnaire will be administered 

to drug court participants once, during 

the 6-month post-discharge interview. 

The estimated response burden for 

this data collection is provided in the 

table below: 

ANNUALIZED ESTIMATES OF HOUR BURDEN

Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total hour 

burden 

Drug court team questionnaire ............................................ 240 3 720 .5 120 

Drug court clients focus group questions for guided discussion ............................................................................. 600 1 600 1.0 600 

Drug court clients—interviews ............................................. 816 1 816 .5 408 

Procedural justice questionnaire .......................................... 816 1 816 .09 73 

Correctional mental health screener—women .................... 408 1 408 .08 33 

Correctional mental health screener—men ......................... 408 1 408 .08 33 

Treatment satisfaction index ................................................ 816 1 816 .08 65 

Total .............................................................................. 1,656 ........................ 2,136 ........................ 1,128 

The estimates in this table reflect the 

maximum burden for participation in 

the Adult Treatment Drug Court CrossSite Evaluation. Burden for drug court 

personnel is aggregated to reflect total 

burden over the three-year study period. 

The drug court personnel questionnaire 

will be administered three times; once 

during each of three study years. Burden 

for the drug court clients is annualized. 

Focus groups and interviews are onetime events. Some drug court clients 

will participate in both a focus group 

and 6-month post-discharge interview. 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by October 8, 2009 to: SAMHSA 

Desk Officer, Human Resources and 

Housing Branch, Office of Management 

and Budget, New Executive Office 

Building, Room 10235, Washington, DC 

20503; due to potential delays in OMB’s 

receipt and processing of mail sent 

through the U.S. Postal Service, 

respondents are encouraged to submit 

comments by fax to: 202–395–5806. 

Dated: August 28, 2009. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. E9–21511 Filed 9–4–09; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0451] (formerly 

Docket No. 2004N–0226) 

Food and Drug Administration 

Modernization Act of 1997: 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

022 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


jlentini on DSKJ8SOYB1PROD with NOTICES
46204 Federal Register / Vol. 74, No. 172 / Tuesday, September 8, 2009 / Notices 

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: 022’’ (Recognition List 

Number: 022), 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: 022’’ to the 

Division of Small Manufacturers, 

International and Consumer Assistance, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave, Bldg. 66, 

rm. 4613, Silver Spring, MD 20993– 

0002. Send two self-addressed adhesive 

labels to assist that office in processing 

your requests, or fax your request to 

301–847–8149. 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.access

data.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: 022 modifications and other 

standards related information. 

FOR FURTHER INFORMATION CONTACT: 

Carol L. Herman, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 3632, Silver Spring, 

MD 20993–0002, 301–796–6574. 

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 

of the act 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 of this document. 

TABLE 1.—FEDERAL REGISTER

CITATION

February 25, 1998 

(63 FR 9561) 

May 27, 2005 (70 

FR 30756) 

October 16, 1998 

(63 FR 55617) 

November 8, 2005 

(70 FR 67713) 

July 12, 1999 (64 

FR 37546) 

March 31, 2006 (71 

FR 16313) 

November 15, 2000 

(65 FR 69022) 

June 23, 2006 (71 

FR 36121) 

May 7, 2001 (66 FR 

23032) 

November 3, 2006 

(71 FR 64718) 

January 14, 2002 

(67 FR 1774) 

May 21, 2007 (72 

FR 28500) 

October 2, 2002 (67 

FR 61893) 

September 12, 2007 

(72 FR 52142) 

April 28, 2003 (68 

FR 22391) 

December 19, 2007 

(72 FR 71924) 

March 8, 2004 (69 

FR 10712) 

September 9, 2008 

(73 FR 52358) 

TABLE 1.—FEDERAL REGISTER

CITATION—Continued 

June 18, 2004 (69 

FR 34176) 

March, 18, 2009 (74 

FR 11586) 

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: 022 

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: 022’’ 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 

1–37 1–80 CGA C–9:2004 (Reaffirmed 2008) Standard Color Marking of Compressed 

Gas Containers for Medical Use 

Withdrawn and replaced with 

newer version 


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TABLE 2.—Continued 

Old Recognition 

No. 

Replacement 

Recognition 

No. 

Standard Change 

1–68 1–81 CGA V–5:2008 Diameter-Index Safety System Noninterchangeable Low 

Pressure Connections for Medical Gas Applications 

Withdrawn and replaced with 

newer version 

1–51 ASTM F1100–90 (1997) Standard Specification for Ventilators Intended for 

Use in Critical Care 

Withdrawn 

1–59 ASTM F1456–01 Standard Specification for Minimum Performance and 

Safety Requirements for Capnometers 

Withdrawn 

B. Biocompatibility 

2–64 ANSI/AAMI/ISO 10993–5:1999 Biological Evaluation of Medical Devices— 

Part 5: Tests for In Vitro Cytotoxicity 

Contact person, Extent of recognition and Relevant guidance 

2–82 ASTM F2147–01 Standard Practice for Guinea Pig: Split Adjuvant and 

Closed Patch Testing for Contact Allergens 

Contact person and Extent of 

recognition 

2–83 2–136 ASTM E1262–88 (Reapproved 2008) Standard Guide for Performance of 

Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl 

Transferase Gene Mutation Assay 

Withdrawn and replaced with 

newer version 

2–84 2–137 ASTM E1263–97 (Reapproved 2008) Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes Withdrawn and replaced with 

newer version 

2–85 2–138 ASTM E1280–97 (Reapproved 2008) Standard Guide for Performing the 

Mouse Lymphoma Assay for Mammalian Cell Mutagenicity 

Withdrawn and replaced with 

newer version 

2–87 ISO 10993–10:2002 Biological Evaluation of Medical Devices—Part 10: 

Tests for Irritation and Delayed-type Hypersensitivity 

Extent of recognition and Relevant guidance 

2–90 2–139 ASTM E1397–91 (Reapproved 2008) Standard Practice for In Vitro Rat 

Hepatocyte DNA Repair Assay 

Withdrawn and replaced with 

newer version 

2–91 2–140 ASTM E1398–91 (Reapproved 2008) Standard Practice for In Vivo Rat 

Hepatocyte DNA Repair Assay 

Withdrawn and replaced with 

newer version 

2–93 ASTM F763–04 Standard Practice for Short-Term Screening of Implant Materials Extent of recognition and 

Contact person 

2–94 ASTM F981–04 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on 

Muscle and Bone 

Extent of recognition and 

Contact person 

2–95 2–141 ASTM F1984–99 (Reapproved 2008) Standard Practice for Testing for 

Whole Complement Activation in Serum by Solid Materials 

Withdrawn and replaced with 

newer version 

2–97 2–142 ASTM F1983–99 (Reapproved 2008) Standard Practice for Assessment of 

Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications 

Withdrawn and replaced with 

newer version 

2–98 ANSI/AAMI/ISO 10993–1:2003 Biological Evaluation of Medical Devices— 

Part 1: Evaluation and Testing 

Title, Extent of recognition, 

Relevant guidance and 

Contact person 

2–99 2–143 ASTM F1904–98 (Reapproved 2008) Standard Practice for Testing the Biological Responses to Particles in vivo Withdrawn and replaced with 

newer version 

2–100 ASTM E1372–95 (Reapproved 2003) Standard Test Method for Conducting 

a 90-Day Oral Toxicity Study in Rats 

Contact person 

2–106 2–144 ASTM F619–03 (Reapproved 2008) Standard Practice for Extraction of 

Medical Plastics 

Withdrawn and replaced with 

newer version 

2–108 ASTM F1905–98(2003) Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity Contact person and Extent of 

recognition 

2–114 ASTM F1877–05 Standard Practice for Characterization of Particles Extent of recognition and 

Contact person 


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TABLE 2.—Continued 

Old Recognition 

No. 

Replacement 

Recognition 

No. 

Standard Change 

2–115 ASTM F895–84 (Reapproved 2006) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity Extent of recognition, Relevant guidance and Contact 

person 

2–116 2–145 ASTM F1439–03 (Reapproved 2008) Standard Guide for Performance of 

Lifetime Bioassay for the Tumorigenic Potential of Implant Materials 

Withdrawn and replaced with 

newer version 

2–118 ANSI/AAMI/ISO 10993–11:2006 Biological Evaluation of Medical Devices— 

Part 11: Tests for Systemic Toxicity 

Extent of recognition, Relevant guidance and Contact 

person 

2–119 ASTM F813–07 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices Contact person 

2–121 2–146 ASTM F2148–07Ö1 Standard Practice for Evaluation of Delayed Contact 

Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA) 

Withdrawn and replaced with 

newer version 

2–122 ASTM F719–81 (Reapproved 2007)Ö1 Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation Contact person and Relevant 

guidance 

2–124 ASTM F750–87 (Reapproved 2007)Ö1 Standard Practice for Evaluating 

Material Extracts by Systemic Injection in the Mouse 

Extent of recognition, Relevant guidance and Contact 

person 

2–125 ASTM F749–98 (Reapproved 2007)Ö1 Standard Practice for Evaluating 

Material Extracts by Intracutaneous Injection in the Rabbit 

Extent of recognition, Relevant guidance and Contact 

person 

2–126 ASTM F748–06 Standard Practice for Selecting Generic Biological Test 

Methods for Materials and Devices 

Extent of recognition, Relevant guidance and Contact 

person 

2–128 2–147 USP 32–NF26 Biological Tests <87> 2009 Biological Reactivity Test, In 

Vitro—Direct Contact Test 

Withdrawn and replaced with 

newer version 

2–129 2–148 USP 32–NF26 Biological Tests <88> Biological Reactivity Test, In Vitro— 

Elution Test 

Withdrawn and replaced with 

newer version 

2–130 2–149 USP 32–NF26 Biological Tests <88> Biological Reactivity Tests, In Vivo 

Procedure—Preparation of Sample 

Withdrawn and replaced with 

newer version 

2–131 2–150 USP 32–NF26 Biological Tests <88> Biological Reactivity Test, In Vivo, 

Classification of Plastics—Intracutaneous Test 

Withdrawn and replaced with 

newer version 

2–132 2–151 USP 32–NF26 Biological Tests <88> Biological Reactivity Tests, In Vivo, 

Classification of Plastics—Systemic Injection Test 

Withdrawn and replaced with 

newer version 

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

Screening Test for Implant Materials 

Contact person 

2–134 ASTM F2065–00 (2006) Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials Contact person 

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

Part 12: Sample Preparation and Reference Materials 

Extent of recognition, Relevant guidance and Contact 

person 

C. Dental/ENT 

4–69 4–178 ISO 6872:2008 Dentistry—Ceramic Materials Withdrawn and replaced with 

newer version 

4–73 4–179 ISO 7405: 2008 Dentistry—Evaluation of Biocompatibility of Medical Devices Used in Dentistry Withdrawn and replaced with 

newer version 

4–175 ANSI ASA S3.46–1997 (R 2007) Methods of Measurement of Real-Ear 

Performance Characteristics of Hearing Aids 

Reaffirmation 

D. General 


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TABLE 2.—Continued 

Old Recognition 

No. 

Replacement 

Recognition 

No. 

Standard Change 

5–12 5–47 ISO 10012:2003 Measurement Management Systems—Requirements for 

Measurement Processes and Measuring Equipment 

Withdrawn and replaced with 

newer version 

5–15 5–48 ANSI/ASQ Z1.9–2008 Sampling Procedures and Tables for Inspection by 

Variables for Percent Nonconforming 

Withdrawn and replaced with 

newer version 

5–27 IEC 60601–1–1 Ed. 2.0 2000 Medical Electrical Equipment—Part 1–1: General Requirements for Safety—Collateral Standard: Safety requirements 

for Medical Electrical Systems 

Title 

5–36 ISO/TR 16142:2006 Medical Devices—Guidance on the Selection of Standards in Support of Recognized Essential Principles of Safety and Performance of Medical Devices Title 

5–41 IEC 60601–1–4 (2000) Consol. Ed. 1.1 Medical Electrical Equipment—Part 

1–4: General Requirements for Safety—Collateral Standard: Programmable Electrical Medical Systems 

Title 

5–44 5–49 IEC 60601–1–8, Ed. 1 Medical Electrical Equipment—Part 1–8: General 

Requirements for Safety—Collateral Standard: Alarm Systems—Requirements, Tests and Guidelines—General Requirements and Guidelines for 

Alarm Systems in Medical Equipment 

Withdrawn and re-recognized 

previous version 

E. General Hospital/General Plastic Surgery 

6–63 6–216 ISO 8536–7:2009 Infusion Equipment for Medical Use—Part 7: Caps Made 

of Aluminum-plastics Combinations for Infusion Bottles 

Withdrawn and replaced with 

newer version 

6–112 ANSI/AAMI PB70:2003 Liquid Barrier Performance and Classification of 

Protective Apparel and Drapes Intended for Use in Health Care Facilities 

Contact person 

6–118 ASTM F2196–02 Standard Specification for Circulating Liquid and Forced 

Air Patient Temperature Management Devices 

CFR citation and product 

code 

6–144 ASTM D5712—05Ö1 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified 

Lowry Method 

Title and Contact person 

6–145 ASTM D3578–05Ö1 Standard Specification for Rubber Examination Gloves Title and Contact person 

6–147 ASTM D6978–05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs Contact person and Relevant 

guidance 

6–149 ASTM D7160–05 Standard Practice for Determination of Expiration Dating 

for Medical Gloves 

Contact person 

6–150 ASTM D7161–05 Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse 

Conditions 

Contact person 

6–165 ASTM D6977–04Ö1 Standard Specification for Polychloroprene Examination Gloves for Medical Application Title and Contact person 

6–167 ASTM D6319–00a (Reapproved 2005)Ö1 Standard Specification for Nitrile 

Examination Gloves for Medical Application 

Title and Contact person 

6–168 ASTM D3577–09Ö1 Standard Specification for Rubber Surgical Gloves Withdrawn and replaced with 

newer version 

6–175 ASTM D5151–06 Standard Test Method for Detection of Holes in Medical 

Gloves 

Contact person 

6–178 ASTM D6124–06 Standard Test Method for Residual Powder on Medical 

Gloves 

Contact person 

6–183 ASTM D5250–06Ö1 Standard Specification for Poly(vinyl chloride) Gloves 

for Medical Application 

Title and Contact person 

6–186 6–217 ASTM F1670–08 Standard Test Method for Resistance of Materials Used in 

Protective Clothing to Penetration by Synthetic Blood 

Withdrawn and replaced with 

newer version 


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TABLE 2.—Continued 

Old Recognition 

No. 

Replacement 

Recognition 

No. 

Standard Change 

6–205 6–218 USP 32:2009 Nonabsorbable Surgical Suture Withdrawn and replaced with 

newer version 

6–206 6–219 USP 32<11>:2009 Sterile Sodium Chloride for Irrigation Withdrawn and replaced with 

newer version 

6–207 6–220 USP 32:2009 Absorbable Surgical Suture Withdrawn and replaced with 

newer version 

6–208 6–221 USP 32<881>:2009 Tensile Strength Withdrawn and replaced with 

newer version 

6–209 6–222 USP 32<861>:2009 Sutures—Diameter Withdrawn and replaced with 

newer version 

6–210 6–223 USP 32<871>:2009 Sutures Needle Attachment Withdrawn and replaced with 

newer version 

6–211 6–224 USP 32<11>:2009 Sterile Water for Irrigation Withdrawn and replaced with 

newer version 

6–212 6–225 USP 32<11>:2009 Heparin Lock Flush Solution Withdrawn and replaced with 

newer version 

6–213 6–226 USP 32<11>:2009 Sodium Chloride Injection Withdrawn and replaced with 

newer version 

F. In Vitro Diagnostics 

7–156 7–195 CLSI M02–A10, Performance Standards for Antimicrobial Disk Susceptibility 

Tests 

Withdrawn and replaced with 

newer version 

7–158 7–196 CLSI M07–A8, Methods for Dilution Antimicrobial Susceptibility Tests for 

Bacteria that Grow Aerobically 

Withdrawn and replaced with 

newer version 

7–160 7–197 CLSI M35–A2, Abbreviated Identification of Bacteria and Yeast Withdrawn and replaced with 

newer version 

7–78 7–198 CLSI M23–A3, Development of In Vitro Susceptibility Testing Criteria and 

Quality Control Parameters 

Withdrawn and replaced with 

newer version 

7–177 7–199 CLSI M100–S19 Performance Standards for Antimicrobial Susceptibility 

Testing 

Withdrawn and replaced with 

newer version 

7–161 7–200 CLSI M48–A, Laboratory Detection and Identification of Mycobacteria Withdrawn and replaced with 

newer version 

7–102 NCCLS H1–A5, Tubes and Additives for Venous Blood Specimen Collection Contact Person 

7–101 NCCLS H51–A, Assays of vonWillebrand Factor Antigen and Ristocetin Cofactor Activity Contact Person 

7–165 CLSI H20–A2, Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods Contact Person 

7–103 7–201 CLSI H3–A6, Procedures for the Collection of Diagnostic Blood Specimens 

by Venipuncture 

Withdrawn and replaced with 

newer version 

7–81 7–202 CLSI C28–A3 Defining, Establishing, and Verifying Reference Intervals in 

the Clinical Laboratory 

Withdrawn and replaced with 

newer version 

7–144 7–203 CLSI H04–A6, Procedures and Devices for the Collection of Diagnostic 

Capillary Blood Specimens 

Withdrawn and replaced with 

newer version 

G. Materials 

8–32 8–163 ASTM F1586–08 Standard Specification for Wrought Nitrogen Strengthened 

21 Chromium-10Nickel-3Manganese-2.5Molybdenum Stainless Steel Bar 

for Surgical Implants (UNS S31675) 

Withdrawn and replaced with 

newer version 


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TABLE 2.—Continued 

Old Recognition 

No. 

Replacement 

Recognition 

No. 

Standard Change 

8–44 8–164 ASTM F136–08Ö1 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant 

Applications (UNS R56401) 

Withdrawn and replaced with 

newer version 

8–49 8–165 ASTM F1058–08 Standard Specification for Wrought 40Cobalt20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire and Strip for Surgical Implant Applications (UNS R30003 and UNS R30008) Withdrawn and replaced with 

newer version 

8–50 8–166 ASTM F1091–08 Standard Specification for Wrought Cobalt-20 Chromium15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605) Withdrawn and replaced with 

newer version 

8–52 8–167 ASTM F1350–08 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673) Withdrawn and replaced with 

newer version 

8–53 8–168 ASTM F1472–08Ö1 Standard Specification for Wrought Titanium 

-6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS 

R56400) 

Withdrawn and replaced with 

newer version 

8–76 8–169 ASTM F138–08 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants 

(UNS S31673) 

Withdrawn and replaced with 

newer version 

8–79 8–170 ASTM F961–08 Standard Specification for 35Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants (UNS 

R30035) 

Withdrawn and replaced with 

newer version 

8–81 8–171 ASTM F1609–08 Standard Specification for Calcium Phosphate Coatings 

for Implantable Materials 

Withdrawn and replaced with 

newer version 

8–86 8–172 ASTM F1926/F1926M–08 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, 

and Coatings 

Withdrawn and replaced with 

newer version 

8–94 8–173 ASTM F601–03 (Reapproved 2008) Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants Withdrawn and replaced with 

newer version 

8–95 8–174 ASTM F629–02 (Reapproved 2007)Ö1 Standard Practice for Radiography 

of Cast Metallic Surgical Implants 

Withdrawn and replaced with 

newer version 

8–110 8–175 ASTM F1377–08 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) Withdrawn and replaced with 

newer version 

8–118 8–176 ASTM F2503–08 Standard Practice for Marking Medical Devices and Other 

Items for Safety in the Magnetic Resonance Environment 

Withdrawn and replaced with 

newer version 

8–133 8–177 ASTM F2129–08 Standard Test Method for Conducting Cyclic 

Potentiodynamic Polarization Measurements to Determine the Corrosion 

Susceptibility of Small Implant Devices 

Withdrawn and replaced with 

newer version 

8–143 8–178 ASTM F648–07Ö1 Standard Specification for Ultra-High-Molecular-Weight 

Polyethylene Powder and Fabricated Form for Surgical Implants 

Withdrawn and replaced with 

newer version 

8–144 8–179 ASTM F754–08 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular 

Molding Powders 

Withdrawn and replaced with 

newer version 

8–146 8–180 ASTM F2066–08 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150) Withdrawn and replaced with 

newer version 

8–148 8–181 ASTM F899–09 Standard Specification for Wrought Stainless Steels for 

Surgical Instruments 

Withdrawn and replaced with 

newer version 

8–152 8–182 ASTM F1537–08 Standard Specification for Wrought Cobalt-28-Chromium6-Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, 

and UNS R31539) 

Withdrawn and replaced with 

newer version 

8–160 8–183 ASTM F560–08 Standard Specification for Unalloyed Tantalum for Surgical 

Implant Applications (UNS R05200, UNS R05400) 

Withdrawn and replaced with 

newer version 


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TABLE 2.—Continued 

Old Recognition 

No. 

Replacement 

Recognition 

No. 

Standard Change 

8–161 8–184 ASTM F2516–07Ö2 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials Withdrawn and replaced with 

newer version 

8–162 8–185 ASTM F451–08 Standard Specification for Acrylic Bone Cement Withdrawn and replaced with 

newer version 

H. OB-GYN/Gastroenterology 

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

9–41 9–58 ASTM D6324–08 Standard Test Methods for Male Condoms Made from 

Polyurethane 

Withdrawn and replaced with 

newer version 

9–43 ISO 16038:2005 Rubber condoms—Guidance on the Use of ISO 4074 in 

the Quality Management of Natural Rubber Latex Condoms 

Relevant guidance 

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

Condoms) 

Relevant guidance 

9–57 ISO 4074:2002/Cor.2:2008(E) Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 2 Relevant guidance 

I. Orthopedics 

11–172 11–211 ASTM F1798–97 (Reapproved 2008) Standard Guide for Evaluating the 

Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants 

Withdrawn and replaced with 

newer version 

11–178 11–212 ASTM F1440–92 (Reapproved 2008) Standard Practice for Cyclic Fatigue 

Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion 

Withdrawn and replaced with 

newer version 

11–192 11–213 ASTM F1223–08 Standard Test Method for Determination of Total Knee 

Replacement Constraint 

Withdrawn and replaced with 

newer version 

11–198 11–214 ASTM F0382–99 (Reapproved 2008) Standard Specification and Test 

Method for Metallic Bone Plates 

Withdrawn and replaced with 

newer version 

11–204 11–215 ASTM F897–02 (Reapproved 2007) Standard Test Method for Measuring 

Fretting Corrosion of Osteosynthesis Plates and Screws 

Withdrawn and replaced with 

newer version 

11–205 11–216 ASTM F1264–03 (Reapproved 2007)Ö1 Standard Specification and Test 

Methods for Intramedullary Fixation Devices 

Withdrawn and replaced with 

newer version 

11–209 11–217 ASTM F2083–08Ö1 Standard Specification for Total Knee Prosthesis Withdrawn and replaced with 

newer version 

J. Radiology 

12–17 12–192 NEMA MS 8–2008 Characterization of the Specific Absorption Rate for 

Magnetic Resonance Imaging Systems 

Withdrawn and replaced with 

new version 

12–48 12–193 AIUM AOL 2008 Acoustic Output Labeling Standard for Diagnostic 

Ultrasound Equipment Revision 1- A Standard for How Manufacturers 

Should Specify Acoustic Output Data 

Withdrawn and replaced with 

newer version 

12–58 12–194 ANSI/HPS N43.6–2007 Sealed Radioactive Sources—Classification Withdrawn and replaced with 

newer version 

12–69 12–195 NEMA MS 6–2008 Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging Withdrawn and replaced with 

newer version 

12–95 12–196 NEMA MS 2–2008 Determination of Two-Dimensional Geometric Distortion 

in Diagnostic Magnetic Resonance Images 

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 Contact person 


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TABLE 2.—Continued 

Old Recognition 

No. 

Replacement 

Recognition 

No. 

Standard Change 

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

Ultrasound Equipment Version 3 

Contact person 

12–139 AIUM AOMS–2004 Acoustic Output Measurement Standard for Diagnostic 

Ultrasound Equipment 

Title and Contact person 

12–140 AIUM RTD1–2004 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 1 Title and Contact person 

12–146 IEC 60601–2–17 (2004) Medical Electrical Equipment—Part 2–17: Particular Requirements for the Safety of Automatically-controlled 

Brachytherapy Afterloading Equipment 

Title 

12–147 IEC 60601–2–5: (2000) Medical Electrical Equipment—Part 2–5: Particular 

Requirements for the Safety of Ultrasonic Physiotherapy Equipment Ed. 

2.0 

Title 

12–169 12–197 IEC 60601–2–22 (1995) Medical Electrical Equipment—Part 2–22: Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment—Edition 

2.0 

Withdrawn and re-recognized 

previous version 

12–178 IEC 60601–2–45 Ed. 2.0, (2001), Medical electrical equipment—Part 2–45: 

Particular requirements for the safety of mammographic X-ray equipment 

and mammographic stereotactic devices 

Title 

12–182 12–198 IEC 60601–2–37 (2004), (2005) Amendment 2, Medical Electrical Equipment—Part 2–37: Particular Requirements for the Safety of Ultrasonic 

Medical Diagnostic and Monitoring Equipment 

Withdrawn and re-recognized 

previous version 

12–185 12–199 IEC 60601–1–3: 1994 Medical Electrical Equipment—Part 1: General Requirements for Safety 3. Collateral Standard: General Requirements for 

Radiation Protection in Diagnostic X-ray Equipment—First Edition 

Withdrawn and re-recognize 

previous version 

12–186 12–200 IEC 60601–2–29 (1999) Medical Electrical Equipment Part 2–29: Particular 

Requirements for the Safety of Radiotherapy Simulators—Second Edition 

Withdrawn and re-recognized 

previous version 

K. Software/Informatics 

13–16 13–29 CLSI LIS01–A2 Specification for Low-Level Protocol to Transfer Messages 

Between Clinical Laboratory Instruments and Computer Systems 

Withdrawn and replaced with 

newer version 

L. Sterility 

14–55 ANSI/AAMI/ISO 14160:1998/(R) 2008 Sterilization of Single-use Medical 

Devices Incorporating Materials of Animal Origin—Validation and Routine 

Control of Sterilization by Liquid Chemical Sterilants 

Reaffirmation 

14–88 ANSI/AAMI/ ISO 14937:2000 Sterilization of Health Care Products—General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for 

Medical Devices. 

Contact person 

14–116 ANSI/AAMI ST72:2002 Bacterial Endotoxins—Test Methodologies, Routine 

Monitoring, and Alternatives to Batch Testing 

Relevant guidance and Extent 

of recognition 

14–135 ANSI/AAMI ST63:2002 Sterilization of Health Care Products—Requirements for the Development, Validation, and Routine Control of an Industrial Sterilization Process for Medical Devices—Dry Heat Relevant Guidance 

14–164 ANSI/AAMI ST81:2004 Sterilization of Medical Devices—Information to be 

Provided by the Manufacturer for the Processing of Resterilizable Medical 

Devices 

Contact Person 

14–195 ANSI/AAMI/ISO 11140–1:2005 Sterilization of Health Care Products— 

Chemical Indicators—Part 1: General Requirements 

Relevant Guidance, Extent of 

Recognition and Contact 

person 


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TABLE 2.—Continued 

Old Recognition 

No. 

Replacement 

Recognition 

No. 

Standard Change 

14–220 14–263 ANSI/AAMI ST79:2006/A1:2008 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities Withdrawn and replaced with 

newer version 

14–223 ANSI/AAMI/ISO 11138–1:2006 Sterilization of Health Care Products—Biological Indicators—Part 1: General Requirements Relevant Guidance 

14–224 ANSI/AAMI/ISO 11137–1:2006 Sterilization of Health Care Products—Radiation—Part 1: Requirements for Development, Validation, and Routine 

Control of a Sterilization Process for Medical Devices 

Relevant Guidance 

14–225 ANSI/AAMI/ISO 11137–2:2006 Sterilization of Health Care Products—Radiation—Part 2: Establishing the Sterilization Dose Relevant Guidance 

14–226 ANSI/AAMI/ISO 11137–3:2006 Sterilization of Health Care Products—Radiation—Part 3: Guidance on Dosimetric Aspects Relevant Guidance 

14–228 ANSI/AAMI/ISO 11135–1:2007 Sterilization of Health Care Products—Ethylene oxide—Part 1: Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical Devices Relevant Guidance 

14–261 ANSI/AAMI/ISO 17665–1:2006 Sterilization of Health Care Products—Moist 

Heat—Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices 

Relevant Guidance 

14–119 ANSI/AAMI ST55:2003/(R)2008 Table-top Steam Sterilizers Reaffirmation 

14–71 14–264 ANSI/AAMI ST8:2008 Hospital Steam Sterilizers Withdrawn and replaced with 

newer version 

14–249 14–265 USP 32:2009 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests Withdrawn and replaced with 

newer version 

14–250 14–266 USP 32:2009 <71> Sterility Tests Withdrawn and replaced with 

newer version 

14–251 14–267 USP 32:2009 <85> Bacterial Endotoxins Test Withdrawn and replaced with 

newer version 

14–252 14–268 USP 32:2009 <151> Pyrogen Test (USP Rabbit Test) Withdrawn and replaced with 

newer version 

14–253 14–269 USP 32:2009 <161> Transfusion and Infusion Assemblies and Similar Medical Devices Withdrawn and replaced with 

newer version 

14–254 14–270 USP 32:2009 Biological Indicator for Steam Sterilization—Self Contained Withdrawn and replaced with 

newer version 

14–246 14–271 USP 32:2009 Biological Indicator for Dry-Heat Sterilization, Paper Carrier Withdrawn and replaced with 

newer version 

14–247 14–272 USP 32:2009 Biological Indicator for Ethylene Oxide Sterilization, Paper 

Carrier 

Withdrawn and replaced with 

newer version 

14–248 14–273 USP 32:2009 Biological Indicator for Steam Sterilization, Paper Carrier Withdrawn and replaced with 

newer version 

14–238 ANSI/AAMI/ISO 11140–5:2007 Sterilization of Health Care Products— 

Chemical Indicators—Part 5: Class 2 Indicators for Bowie and Dick-type 

Air Removal Tests 

Contact person and Relevant 

guidance 

14–171 14–274 ANSI/AAMI/ISO 15882:2008 Chemical Indicators—Guidance on the Selection, Use, and Interpretation of Results Withdrawn and replaced with 

newer version 

14–49 14–275 ANSI/AAMI ST41:2008 Ethylene oxide Sterilization in Health Care Facilities: 

Safety and Effectiveness 

Withdrawn and replaced with 

newer version 

14–136 ANSI/AAMI ST67:2003/(R) 2008 Sterilization of Health Care Products—Requirements for Products Labeled ‘‘STERILE’’ Reaffirmation and Relevant 

guidance 


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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: 022. 

TABLE 3. 

Recognition No. Title of Standard Reference No. & Date 

A. Biocompatibility 

2–152 Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-type 

Hypersensitivity Amendment 1 

ISO 10993 10:2002/ 

Amd.1:2006(E) 

B. General 

5–46 Sampling Procedures for Inspection by Attributes—Part 1: Sampling Schemes Indexed by 

Acceptance Quality Limit (AQL) for Lot-by-lot Inspection 

ISO 2859–1:1999/Cor 1:2001 

5–50 Medical Devices—Application of Usability Engineering to Medical Devices IEC 62366:2007 

C. In Vitro Diagnostics 

7–204 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts CLSI M27–A3 

D. Materials 

8–186 Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene 

(UHMWPE) Used in Orthopedic and Spinal Devices 

ASTM F 2759—09 

8–187 Implants for Surgery—Hydroxyapatite—Part 1: Ceramic Hydroxyapatite ISO 13779–1:2008(E) 

8–188 Implants for Surgery—Hydroxyapatite—Part 2: Coatings of Hydroxyapatite ISO 13779–2:2008(E) 

E. Neurology 

17–8 Implants for Surgery—Active Implantable Medical Devices Part 3: Implantable 

Neurostimulators (Neurology) 

ISO 14708–3 2008–11–15 

F. OB-GYN/Gastroenterology 

9–59 Hemodialysis Systems ANSI/AAMI RD5:2003/(R) 

2008 

G. Orthopedics 

11–218 Implants for surgery—Wear of Total Knee-joint Prostheses—Part 3: Loading and Displacement Parameters for Wear-testing Machines with Displacement Control and Corresponding Environmental Conditions for Test ISO 14243–3:2004 Technical 

Corrigendum 1 

H. Sterility 

14–276 Sterilization of Health Care Products—Moist Heat—Part 2: Guidance on the Application of 

ISO 17665–1 

ISO/TS 17665–2:2009 

14–277 Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms USP32:2009 <62> 

14–278 Biological Evaluation of Medical Devices—Part 7: Ethylene Oxide Sterilization Residuals ANSI/AAMI/ISO 10993– 

7:2008 

I. Tissue Engineering 

15–14 Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds ASTM F2603–06 

15–15 Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy ASTM F2259–03 (Reapproved 2008) 

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.access

data.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. 


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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: 022’’ 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: 

022. These modifications to the list or 

recognized standards are effective upon 

publication of this document in the 

Federal Register. 

Dated: August 26, 2009. 

Catherine M. Cook, 

Associate Director for Regulation and Policy. 

[FR Doc. E9–21609 Filed 9–4–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention (CDC) 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel: Capacity Building 

Assistance (CBA) To Improve the 

Delivery and Effectiveness of Human 

Immunodeficiency Virus (HIV) 

Prevention Services for High-Risk and/ 

or Racial/Ethnicity Minority 

Populations, Program Announcement 

Number PS09–906, Initial Review 

DATES: August 28, 2009. 

Correction: This notice was published 

in the Federal Register on August 6, 

2009, Volume 74, Number 150, page 

39333. The date on the original notice 

has changed. 

CONTACT PERSON FOR MORE INFORMATION: 

Monica Farmer, M.Ed., Public Health 

Analyst, Strategic Science and Program 

Unit, Office of the Director, 

Coordinating Center for Infectious 

Diseases, CDC, 1600 Clifton Road, NE., 

Mailstop E–60, Atlanta, GA 30333. 

Telephone (404) 498–2277. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both CDC 

and the Agency for Toxic Substances 

and Disease Registry. 

Dated: August 25, 2009. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E9–21510 Filed 9–4–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

2009 Parenteral Drug Association and 

Food and Drug Administration Joint 

Regulatory Conference 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting. 

SUMMARY: The Food and Drug 

Administration (FDA) in co-sponsorship 

with the Parenteral Drug Association 

(PDA), is announcing a conference 

entitled ‘‘Securing the Future of Medical 

Product Quality: A 2020 Vision.’’ The 

workshop helps to achieve objectives set 

forth in the FDA Modernization Act of 

1997, which include working closely 

with stakeholders and maximizing the 

availability and clarity of information to 

stakeholders and the public. 

Date and Time: The conference will 

be held on Monday, September 14, 2009 

from 8 a.m. to 6 p.m.; Tuesday, 

September 15, 2009 from 7:15 a.m. to 

5:45 p.m.; and Wednesday, September 

16 from 7:15 a.m. to 1:15 p.m. 

Location: The public workshop will 

be held at the Renaissance Hotel, 999 

9th St., Washington, D.C., 20001; 1– 

202–898–9000; FAX: 1–202–289–0947. 

Contact: Regarding the conference: 

Wanda Neal, Parenteral Drug 

Association, PDA Global Headquarters, 

Bethesda Towers, 4350 East-West Hwy., 

suite 200, Bethesda, MD 20814. 

Regarding this document: Ken Nolan, 

Office of External Relations, Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 15–05, Rockville, MD 20857, 

301–827–3376. 

Registration: You are encouraged to 

register at your earliest convenience. 

The PDA registration fees cover the cost 

of facilities, materials, and breaks. Seats 

are limited; please submit your 

registration as soon as possible. 

Conference space will be filled in order 

of receipt of registration. Those accepted 

in to the conference will receive 

confirmation. Registration will close 

after applicable conference is filled. 

Onsite registration will be available on 

a space-available basis on the day of the 

public conference, beginning at 7 a.m. 

on Monday, September 14, 2009. 

The cost of registration is as follows: 

PDA Members ......... $1850.00 

PDA Non-members $2099.00 

Government ............ $700.00 

PDA Member Academic/Health Authority.$700.00 


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