46008 Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices 

Dated: July 30, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–18128 Filed 8–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0056] (formerly 

Docket No. 2004N–0234) 

Annual Guidance Agenda 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing its 

annual guidance document agenda. This 

list is being published under FDA’s 

good guidance practices (GGPs) 

regulations. It is intended to seek public 

comment on possible topics for future 

guidance document development or 

revisions of existing ones. 

DATES: Submit comments on this list 

and on any agency guidance documents 

at any time. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2004–N–

0056, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal, as 

described previously, in the ADDRESSES

portion of this document under 

Electronic Submissions. 

Instructions: All submissions received 

must include the agency name and 

docket number for this notice. All 

comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: For 

general information regarding FDA’s 

GGP policy contact: Lisa Helmanis, 

Office of Policy (HF–26), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–3480. 

For information regarding specific 

topics or guidances: Please see contact 

persons listed in the table in the 

SUPPLEMENTARY INFORMATION section. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of September 

19, 2000 (65 FR 56468), FDA issued its 

final rule on GGPs (21 CFR 10.115). 

GGPs are intended to ensure 

involvement of the public in the 

development of guidance documents 

and to enhance understanding of the 

availability, nature, and legal effect of 

such guidance documents. 

As part of FDA’s effort to ensure 

meaningful interaction with the public 

regarding guidance documents, the 

agency committed to publishing an 

annual guidance document agenda of 

possible guidance topics or documents 

for development or revision during the 

coming year. The agency also 

committed to soliciting public input 

regarding these and additional ideas for 

new topics or revisions to existing 

guidance documents (65 FR 56468 at 

56477; 21 CFR 10.115(f)(5)). 

The agency is neither bound by this 

list of possible topics nor required to 

issue every guidance document on this 

list or precluded from issuing guidance 

documents not on the list set forth in 

this document. 

The following list of guidance topics 

or documents represents possible new 

topics or revisions to existing guidance 

documents that the agency is 

considering. The agency solicits 

comments on the topics listed in this 

document and also seeks additional 

ideas from the public. 

The guidance documents are 

organized by the issuing Center or 

Office within FDA, and are further 

grouped by topic categories. The 

agency’s contact persons for each 

specific area are listed in the tables that 

follow. 

II. Center for Biologics Evaluation and 

Research (CBER) 

Title/Topic of Guidance Contact 

CATEGORY—BLOOD AND BLOOD COMPONENTS Stephen Ripley, Center for Biologics Evaluation and Research 

(HFM–17), Food and Drug Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448, 301–

827–6210 

Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion Same as above (Do) 

Assessment of Donors of Blood and Blood Components for Transfusion Transmitted Malaria Risk Do 

Use of Serological of Tests on Samples from Donors of Whole Blood and Blood Components for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) to Reduce the Risk of Transmission of Trypanosoma cruzi Infection Do 

CATEGORY—VACCINES AND ALLERGENICS 

Considerations for the Development of Vaccines to Protect Against Global Infectious Diseases Do 


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Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices 46009 

Title/Topic of Guidance Contact 

Considerations for the Development of Products that Contain Whole, Live Microorganisms with an Intended Therapeutic or Preventive Effect in Humans Do 

CATEGORY—CELLULAR, TISSUE, AND GENE THERAPY 

Potency Tests for Cell and Gene Therapy Products Do 

Characterization and Qualification of Cell Banks Used in the Production of Cellular and Gene Therapy 

Products 

Do 

Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments Do 

Preparation of INDs for Certain Unlicensed Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Products (HPC-C) Do 

Clinical Study Design for Early Phase Studies of Cellular and Gene Therapies Do 

Clinical Study Design Considerations for Cancer Vaccine Development Do 

Somatic Cell Therapy for Cardiac Disease Do 

Determination of Homologous Use Designation Do 

Devices Involved in Manufacture, Storage and Administration of Cellular Products and Tissues Do 

Preparation of Investigational Device Exemptions and Investigational New Drugs for Tissue Engineered 

and Regenerative Medicine Products 

Do 

III. Center for Drug Evaluation and 

Research (CDER) 

Title/Topic of Guidance Contact 

CATEGORY—ADVERTISING 

Amendment of the Brief Summary Emily T. Thakur, Center for Drug 

Evaluation and Research (HFD–

7), Food and Drug Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 

301–796–3601 

Presentation of Risk Information in Prescription Drug and Medical Device Promotion Do 

CATEGORY—CHEMISTRY 

Assay Development for Immunogenicity Testing Do 

CMC Post-Approval Changes Reportable in an Annual Report Do 

Immunogenicity Assessment for Therapeutic Protein Products Do 

Incorporation of Physical-chemical Indentifiers (PCID) into Solid Oral Dosage Form Drug Products for 

Anticounterfeiting 

Do 

Standards Recognition Do 

Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug 

Products Terminally Sterilized by Moist Heat Processes 

Do 

CATEGORY—CLINICAL/MEDICAL 

Adaptive Trial Designs Do 

Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention Do 

Oncology Endpoints: Non-Small Cell Lunch Cancer Do 

Pain Management: Developing Drug and Biological Products Do 

Risk Management of Highly Suspect or Known Human Teratogens: Pregnancy Prevention Strategies Do 


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Title/Topic of Guidance Contact 

CATEGORY—CLINICAL/PHARMACOLOGY 

End of Phase 2a Meeting Do 

CATEGORY—CLINICAL/STATISTICAL 

Non-Inferiority Trials Do 

CATEGORY—COMBINATION PRODUCTS 

Drug Diagnostic Co-Development Do 

CATEGORY—COMPLIANCE 

Active Pharmaceutical Ingredient (API) Do 

Medical Gas Do 

Non-Penicillin Beta-Lactam Contamination Do 

Pharmacy Compounding of Human Drugs: Compliance Policy Guide, Section 460.200 Do 

Penicillins and Their Definition Do 

PET CGMPs Do 

Pre-Launch Activities Importation Request (PLAIR) Do 

Process Validation: General Principles and Practices Do 

CATEGORY—DRUG SAFETY INFORMATION 

Contents of a Complete Submission Package for a Proposed Proprietary Drug or Biologic Name Do 

Dear Healthcare Professional Letters Do 

Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During Pandemic Influenza Do 

CATEGORY—ELECTRONIC SUBMISSIONS 

Providing Regulatory Submissions in Electronic Format—Analysis Datasets and Documentation Do 

CATEGORY—GENERICS 

Submission of Summary Bioequivalence Data for ANDAs Do 

CATEGORY—IND 

Consumer Product Safety Commission—Tamper Resistant Packaging for INDs Do 

Determining Whether Human Research Studies Can Be Conducted Without an IND Do 

CATEGORY—LABELING 

Content and Format of the Clinical Pharmacology Section Do 

Drug Names and Dosage Forms Do 

Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims Do 

Labeling Dietary Supplements for Women Who are or Could be Pregnant Do 

Labeling Guidance for Inclusion and Placement of Safe Handling Statements in Package Inserts for 

Human Pharmaceuticals 

Do 

CATEGORY—OTC 

Label Comprehension Studies for OTC Drug Products Do 

Labeling of OTC Skin Protectant Drug Products Do 

CATEGORY—PHARMACOLOGY/TOXICOLOGY 

Biotechnology-Derived Pharmaceuticals: Nonclinical Safety Evaluation Do 


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Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices 46011 

Title/Topic of Guidance Contact 

Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches Do 

Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration 

by an Alternate Route 

Do 

CATEGORY—PROCEDURAL 

Assessment of Abuse Potential of Drugs Do 

Determining Whether Human Research With a Radioactive Drug Can Be Conducted Under a Radioactive Drug Research Committee (RDRC) Do 

Formal Meeting Between CDER/CBER Staff and Sponsors Do 

Integrated Summary of Effectiveness Do 

IV. Center for Devices and Radiological 

Health (CDRH) 

Title Contact Person 

Office of Compliance 

Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007 (FDAAA) Tim Ulatowski, Center for Devices 

and Radiological Health (HFZ–

300), 2094 Gaither Rd., Rockville, MD 20850, 240–276–0100 

Surveillance and Detention Without Physical Examination of Condoms Do 

Surveillance and Detention Without Physical Examination of Surgeons’ and/or Patient Examination 

Gloves 

Do 

Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Do 

Manufacturing Site Change Supplements: Content and Inspectional Considerations Do 

Using the Global Harmonization Task Force (GHTF) Clinical Evaluation Guidance (SG5/N2R8:2007) for 

Medical Devices 

Do 

Using the Global Harmonization Task Force (GHTF) Quality Management System—Process Validation 

SG3/N99–10:2004 for Medical Devices 

Do 

Guidance on the Third Party Inspection Program for Medical Devices (FDAAA) Do 

Guidance on Submitting International Standards Organization (ISO) 13485 Audits to FDA for Medical 

Devices Under the Food and Drug Administration Amendments Act of 2007 (FDAAA) 

Do 

30-Day Notices and 135-Day PMA Supplements (FDAAA) Do 

Regulatory Requirements for Foreign and Domestic Dental Laboratories Do 

Using the Global Harmonization Task Force (GHTF) SG1/N041:2005 Essential Principles of Safety & 

Performance for Medical Devices 

Do 

Using the Global Harmonization Task Force (GHTF) SG1 PD/N0011 Summary Technical Documentation 

(STED) for Demonstrating Conformity to the Essential Principles for Medical Devices 

Do 

Using the Global Harmonization Task Force (GHTF) SG3N17 (Proposed) Quality Management System 

Medical Devices management of procured products, outsourced processes and their suppliers 

Do 

Using the Global Harmonization Task Force (GHTF) SG3 (Proposed) Criteria for Characterizing the Significance of Quality Management System Deficiencies for Medical Devices Do 

Using the Global Harmonization Task Force (GHTF) SG1 (Proposed) Multi-site Audits and Audits of 

Suppliers (Suppl 1. to Guidelines for Regulatory Auditing of Quality Management Systems of Medical 

Device Manufacturers—Part 2: Regulatory Auditing Strategy) 

Do 

Office of Communication, Education, and Radiation Programs (OCER) 


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Title Contact Person 

Guidance Regarding Hand-Held X-Ray Equipment Sean Boyd, Center for Devices and 

Radiological Health (HFZ–240), 

1350 Piccard Dr., Rockville, MD 

20850, 240–276–3287 

Impact Resistant Lenses Q&A John Stigi, Center for Devices and 

Radiological Health (HFZ–220), 

1350 Piccard Dr., Rockville, MD 

20850, 240–276–3150 

Office of Science and Engineering Laboratories (OSEL) 

Medical Device Electromagnetic Compatibility Guidance Joel Myklebust, Center for Devices 

and Radiological Health, 10903 

New Hampshire Ave., Silver 

Spring, MD 20933, 301–796–

2491 

Bone Sonometers Keith Wear, Center for Devices and 

Radiological Health, 10903 New 

Hampshire Ave., Silver Spring, 

MD 20933, 240–796–2538 

Risk Management Information in Premarket Submissions William Midgette, Center for Devices and Radiological Health, 

10903 New Hampshire Ave., Silver Spring, MD 20933, 301–796–

2583 

Application of IEC 60601–1 Third Edition in Premarket Applications Alford Taylor, Jr. Center for Devices and Radiological Health, 

10903 New Hampshire Ave., Silver Spring, MD 20933, 301–796–

2583 

Premarket Clearance of Diagnostic Ultrasound Imaging Systems Larry Grossman, Center for Devices and Radiological Health, 

10903 New Hampshire Ave., Silver Spring, MD 20933, 301–796–

2502 

Guidance on the use of the IEC standard(s) for ultrasound therapy systems in lieu of older BRH mandatory standard Do 

Stereotactic Devices Alford Taylor, Jr., Center for Devices and Radiological Health, 

10903 New Hampshire Ave., Silver Spring, MD 20933, 301–796–

2583 

Electroconvulsive Therapy Device Class III Premarket Notification (510k) and Investigational Device Exemption Submissions Joel Myklebust, Center for Devices 

and Radiological Health, 10903 

New Hampshire Ave., Silver 

Spring, MD 20933, 301–796–

2491 

Office of Surveillance and Biometrics 

Bayesean Statistics Gerry Grey, Center for Devices and 

Radiological Health (HFZ–530), 

1350 Piccard Dr., Rockville, MD 

20850, 240–276–3451 

Electronic Premarket Statistical Data Submission Do 

Electronic Medical Device Reporting Howard Press, Center for Devices 

and Radiological Health (HFZ–

530), 1350 Piccard Dr., Rockville, 

MD 20850, 240–276–3457 

CDRH Postmarket Problem Codes Do 


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Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices 46013 

Title Contact Person 

Global Harmonization Task Force (GHTF) Guidance on How to Handle Information Concerning Vigilance 

Reporting Related to Medical Devices 

Do 

FDA’s Use of Global Harmonization Task Force (GHTF) Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form for Medical Devices Do 

Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) 

Invasive Portable Blood Glucose Monitoring System Pat Bernhardt, Center for Devices 

and Radiological Health (HFZ–

440), 2098 Gaither Rd., Rockville 

MD 20850, 240–276–0397 

Class II Special Control Guidance Document: Human Metapneumovirus (hMPV) Nucleic Acid Assays Sally Hojvat, Center for Devices 

and Radiological Health (HFZ–

440), 2098 Gaither Rd., Rockville 

MD 20850, 240–276–0711 

Class II Special Control Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay Do 

Class II Special Controls Guidance Document: Nucleic Acid Assay for Detection and Differentiation of Influenza A Virus Subtypes Do 

Special Controls Guidance Document: Bacillus spp. Serological Reagents; Guidance for Industry and 

FDA 

Do 

Adverse Event Reporting for IVD’s (with appendix on glucose meters) Claudia Gaffey, Center for Devices 

and Radiological Health (HFZ–

440), 2098 Gaither Rd., Rockville 

MD 20850, 240–276–0718 

Class II Special Control Guidance Document: Enterovirus Nucleic Acid Assays Uwe Scherf, Center for Devices 

and Radiological Health (HFZ–

440), 2098 Gaither Rd., Rockville 

MD 20850, 240–276–0725 

Therapeutic Drug Monitoring Assays: Zonisamide and Lamotrigine Avis Danishefsky, Center for Devices and Radiological Health 

(HFZ–440), 2098 Gaither Rd., 

Rockville MD 20850, 240–276–

0687 

Assay Migration Studies for IVD’s Sally Hojvat, Center for Devices 

and Radiological Health (HFZ–

440), 2098 Gaither Rd., Rockville 

MD 20850, 240–276–0711 

Administrative Procedures for CLIA Categorization Procedures Carol Benson, Center for Devices 

and Radiological Health (HFZ–

440), 2098 Gaither Rd., Rockville 

MD 20850, 240–276–0396 

Class II Special Control Guidance Document: Plasmodium Species Antigen Detection Assays Freddie Poole, Center for Devices 

and Radiological Health (HFZ–

440), 2098 Gaither Rd., Rockville 

MD 20850, 240–276–0712 

IVD Multivariate Index Assays Courtney Harper, Center for Devices and Radiological Health 

(HFZ–440), 2098 Gaither Rd., 

Rockville MD 20850, 240–276–

0694 

Office of Device Evaluation (ODE) 

Pediatric HDEs—Guidance for IRBs Stephen Rhodes, Center for Devices and Radiological Health 

(HFZ–403), 9200 Corporate 

Blvd., Rockville, MD 20850, 240–

276–4036 


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46014 Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices 

Title Contact Person 

Sex Differences in Clinical Evaluation of Cardiovascular Devices Bram Zuckerman, Center for Devices and Radiological Health 

(HFZ–450), 9200 Corporate 

Blvd., Rockville, MD 20850, 240–

276–4038 

Condom Labeling, Special Controls Nancy Brogdon, Center for Devices 

and Radiological Health (HFZ–

470), 9200 Corporate Blvd., 

Rockville, MD 20850, 240–276–

3650 

ECG Electrodes SCGD Bram Zuckerman, Center for Devices and Radiological Health 

(HFZ–450), 9200 Corporate 

Blvd., Rockville, MD 20850, 240–

276–4038 

Dental Amalgam Susan Runner, Center for Devices 

and Radiological Health (HFZ–

480), 9200 Corporate Blvd., 

Rockville, MD 20850, 240–276–

3776 

Antimicrobial Agent Devices; Premarket Notification Submissions Chiu Lin, Center for Devices and 

Radiological Health (HFZ–480), 

9200 Corporate Blvd., Rockville, 

MD 20850, 240–276–3742 

Absorbable Hemostatic Devices Mark Melkerson, Center for Devices and Radiological Health 

(HFZ–410), 9200 Corporate 

Blvd., Rockville, MD 20850, 240–

276–3737 

FDA and Industry Actions on Premarket Notification Submissions Samie Niver Allen, Center for Devices and Radiological Health 

(HFZ–402), 9200 Corporate 

Blvd., Rockville, MD 20850, 240–

276–4013 

Annual Reports for PMAs Do 

MDUFMA: Disputes Concerning Payment or Refund of Medical Device User Fees Les Weinstein, Center for Devices 

and Radiological Health (HFZ–5), 

9200 Corporate Blvd., Rockville, 

MD 20850, 240–276–3962 

Topical Oxygen Chamber for Extremities Mark Melkerson, Center for Devices and Radiological Health 

(HFZ–410), 9200 Corporate 

Blvd., Rockville, MD 20850, 240–

276–3737 

MDUFMA: User Fees and Refunds for Premarket Notification Submissions Heather Rosecrans, Center for Devices and Radiological Health 

(HFZ–404), 9200 Corporate 

Blvd., Rockville, MD 20850, 240–

276–4021 

Pulse Oximeters; Submissions Chiu Lin, Center for Devices and 

Radiological Health (HFZ–480), 

9200 Corporate Blvd., Rockville, 

MD 20850, 240–276–3742 

Tracking Pediatric Device Approvals Sec. 302 FDAAA Barbara Buch, Center for Devices 

and Radiological Health (HFZ–

410), 9200 Corporate Blvd., 

Rockville, MD 20850, 240–276–

4000 


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Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices 46015 

Title Contact Person 

Trial Considerations for Hip Joint Replacement Systems Mark Melkerson, Center for Devices and Radiological Health 

(HFZ–410), 9200 Corporate 

Blvd., Rockville, MD 20850, 240–

276–3737 

Replacement Heart Valves; IDE & PMA Applications Bram Zuckerman, Center for Devices and Radiological Health 

(HFZ–450), 9200 Corporate 

Blvd., Rockville, MD 20850, 240–

276–4038 

Retina Prostheses; Preclinical & Clinical Recommendations Malvina Eydelman, Center for Devices and Radiological Health 

(HFZ–400), 9200 Corporate 

Blvd., Rockville, MD 20850, 240–

276–3783 

Bone Graft SCGD Adding Intra-Oral Barrier Membrane Indication Chiu Lin, Center for Devices and 

Radiological Health (HFZ–480), 

9200 Corporate Blvd., Rockville, 

MD 20850, 240–276–3742 

Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities Do 

Pacing Leads Guidance Bram Zuckerman, Center for Devices and Radiological Health 

(HFZ–450), 9200 Corporate 

Blvd., Rockville, MD 20850, 240–

276–3783 

Powered Wheelchairs Mark Melkerson, Center for Devices and Radiological Health 

(HFZ–410), 9200 Corporate 

Blvd., Rockville, MD 20850, 240–

276–3737 

Tissue Adhesive for the Topical Approximation of Skin Do 

FDA and Industry Actions on Premarket Approval Application Samie Niver Allen, Center for Devices and Radiological Health 

(HFZ–402), 9200 Corporate 

Blvd., Rockville, MD 20850, 240–

276–4013 

Pacemaker Lead Adaptor 510(k) Submissions Bram Zuckerman, Center for Devices and Radiological Health 

(HFZ–450), 9200 Corporate 

Blvd., Rockville, MD 20850, 240–

276–4038 

510(k) Paradigm Heather Rosecrans, Center for Devices and Radiological Health 

(HFZ–404), 9200 Corporate 

Blvd., Rockville, MD 20850, 240–

276–4021 

Urinary Incontinence Devices; Clinical Recommendations Nancy Brogdon, Center for Devices 

and Radiological Health (HFZ–

470), 9200 Corporate Blvd., 

Rockville, MD 20850, 240–276–

3650 

Guidance on Dental Mouthguards Chiu Lin, Center for Devices and 

Radiological Health (HFZ–480), 

9200 Corporate Blvd., Rockville, 

MD 20850, 240–276–3742 

Tissue Expander Mark Melkerson, Center for Devices and Radiological Health 

(HFZ–410), 9200 Corporate 

Blvd., Rockville, MD 20850, 240–

276–3737 


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46016 Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices 

Title Contact Person 

PTCA Devices Bram Zuckerman, Center for Devices and Radiological Health 

(HFZ–450), 9200 Corporate 

Blvd., Rockville, MD 20850, 240–

276–4038 

TENS, Muscle Stimulator, and Conductive Gel Guidances Mark Melkerson, Center for Devices and Radiological Health 

(HFZ–410), 9200 Corporate 

Blvd., Rockville, MD 20850, 240–

276–3737 

Sterile Devices in Premarket Notification (510(k)) Submissions Chiu Lin, Center for Devices and 

Radiological Health (HFZ–480), 

9200 Corporate Blvd., Rockville, 

MD 20850, 240–276–3742 

Full Field Digital Mammography Nancy Brogdon, Center for Devices 

and Radiological Health (HFZ–

470), 9200 Corporate Blvd., 

Rockville, MD 20850, 240–276–

3650 

Coronary Drug Eluting Stents Guidance Document Ashley Boam, Center for Devices 

and Radiological Health (HFZ–

450), 9200 Corporate Blvd., 

Rockville, MD 20850, 240–276–

4222 

Modifications to PMA Devices Samie Niver Allen, Center for Devices and Radiological Health 

(HFZ–402), 9200 Corporate 

Blvd., Rockville, MD 20850, 240–

276–4013 

V. Center for Safety and Applied 

Nutrition (CFSAN) 

Title/Topic of Guidance Contact 

New Dietary Ingredient Notifications Guidance Linda Pellicore, CFSAN (HFS–

810), 5100 Paint Branch Pkwy., 

College Park, MD 20740, 301–

436–1448, 

linda.pellicore@fda.hhs.gov 

Fish and Fishery Products Hazards and Control Guidance (Edition 4) Robert Samuels, CFSAN (HFS–

325), 5100 Paint Branch Pkwy., 

College Park, MD 20740 301–

436–1418, robert.samuels@fda.hhs.gov 

Dietary Guidance Statements Kathy Ellwood, CFSAN (HFS–830), 

5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–

1450, 

kathy.ellwood@fda.hhs.gov 

Providing Regulatory Submissions in Electronic Format—Food Additive Petitions, Color Additive Petitions, 

Food Contact Notifications, Food Master Files, GRAS Notices, Biotechnology Consultations, and New 

Protein Consultations 

Berhane Girmay, CFSAN (HFS–

205), 5100 Paint Branch Pkwy., 

College Park, MD 20740, 301–

436–1194, 

berhane.girmay@fda.hhs.gov 

Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer 

Protection Act of 2004 (Edition 5) 

Rhonda Kane, CFSAN (HFS–820), 

5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–

1803, rhonda.Kane@fda.hhs.gov 


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Title/Topic of Guidance Contact 

The Seafood List—FDA’s Guide to Acceptable Market Names for Seafood Sold in Interstate Commerce Spring Randolph, CFSAN (HFS–

325), 5100 Paint Branch Pkwy., 

College Park, MD 20740, 301–

436–1421, 

spring.randolph@fda.hhs.gov 

Small Entity Compliance Guide: ‘‘Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements’’Vasilios Frankos, CFSAN (HFS–

810), 5100 Paint Branch Pkwy., 

College Park, MD 20740, 301–

436–1850, 

vasilios.frankos@fda.hhs.gov 

Pathogens in Diary Products Draft CPG Bob Childers, CFSAN (HFS–316), 

5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–

1494, bob.childers@fda.hhs.gov 

Prior Notice CPG May Nelson, CFSAN (HFS–024), 

5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–

1722, may.nelson@fda.hhs.gov 

VI. Center for Veterinary Medicine 

Title of Guidance Contact 

Regulation of Genetically Engineered (GE) Animals Containing Heritable nDNA Constructs Larisa Rudenko, Center for Veterinary Medicine (HFV–100), Food 

and Drug Administration, 7500 

Standish Pl., Rockville, MD 

20855, 240–276–8245, e-mail: 

larisa.rudenko@fda.hhs.gov 

Labeling and Marketing of Nutritional Products for Dogs and Cats Intended to Diagnose, Cure, Mitigate, 

Treat, or Prevent Diseases—Compliance Policy Guide—Final 

William J. Burkholder, Center for 

Veterinary Medicine (HFV–228), 

Food and Drug Administration, 

7519 Standish Pl., MPN–4, rm. 

2642, Rockville, MD 20855, william.burkholder@fda.hhs.gov 

Veterinary Drug Compounding Compliance Policy Guide Neal Bataller, Center for Veterinary 

Medicine (HFV–230), Food and 

Drug Administration, 7519 Standish Pl., MPN–4, rm. 143, Rockville, MD 20855, 240–276–9201, 

neal.bataller@fda.hhs.gov 

Voluntary Self Inspection of Medicated Feed Manufacturing Facilities—Compliance Policy Guide Paul Bachman, Center for Veterinary Medicine (HFV–230), Food 

and Drug Administration, 7519 

Standish Pl., MPN–4, rm. 128, 

Rockville, MD 20855, 240–276–

9225, 

paul.bachman@fda.hhs.gov 

Salmonella Contamination of Feeds Compliance Policy Guide Xin Li, Center for Veterinary Medicine (HFV–222), Food and Drug 

Administration, 7519 Standish 

Pl., MPN–4, rm. 221, Rockville, 

MD 20855, 240–453–6863, 

Xin.Lin@fda.hhs.gov 

Criteria for Evaluating Tests for Detection of Animal Proteins Prohibited in Ruminant Feed Dragan Momcilovic, Center for Veterinary Medicine (HFV–220), 

7519 Standish Pl., MPN–4, rm. 

227, Rockville, MD 20855, 240–

453–6856, 

dragan.momcilovic@fda.hhs.gov 


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46018 Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices 

Title of Guidance Contact 

Glucosamine/Chondroitin Animal Products Compliance Policy Guide Paul Bachman, Center for Veterinary Medicine (HFV–230), Food 

and Drug Administration, 7519 

Standish Pl., MPN–4, rm. 128, 

Rockville, MD 20855, 240–276–

9225, 

paul.bachman@fda.hhs.gov 

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Final Guidance for Industry on Target Animal Safety for Veterinary Pharmaceutical Products GL–43 Laura Hungerford, Center for Veterinary Medicine (HFV–143), 

Food and Drug Administration, 

7500 Standish Pl., MPN–2, rm. 

E375, Rockville, MD 20855, 240–

276–8232, 

laura.hungerford@fda.hhs.gov 

Guidance for Industry, Submission of Veterinary Adverse Drug Event Reports to the Center for Veterinary 

Medicine, Form FDA 1932 

Lynn Post, Center for Veterinary 

Medicine (HFV–210), Food and 

Drug Administration, 7519 Standish Pl., MPN–4, rm. 2612, Rockville, MD 20855, 240–276–9062, 

lynn.post@fda.hhs.gov 

Guidance for Industry, Submission of Drug Experience Reports (DER) to the Center for Veterinary Medicine, Form FDA 2301 Lynn Post, Center for Veterinary 

Medicine (HFV–210), Food and 

Drug Administration, 7519 Standish Pl., MPN–4, rm. 2612, Rockville, MD 20855, 240–276–9062, 

lynn.post@fda.hhs.gov 

Draft Guidance for Industry—Documenting Statistical Analyses Bob Abugov, Center for Veterinary 

Medicine (HFV–105), Food and 

Drug Administration, 7500 Standish Pl., MPN–2, rm. N416, Rockville, MD 20855, 240–276–8168, 

robert.abugov@fda.hhs.gov 

Draft Guidance for Industry—Changes to Approved NADAs—New NADA or Supplemental NADA Suzanne Sechen, Center for Veterinary Medicine (HFV–126), Food 

and Drug Administration, 7500 

Standish Pl., MPN–2, rm. N448, 

Rockville, MD 20855, 240–276–

8108, suzanne.sechen@fda.hhs.gov 

Draft Guidance for Industry—Anesthetics for Companion Animals Germaine Connolly, Center for Veterinary Medicine (HFV–116), 

Food and Drug Administration, 

7500 Standish Pl., MPN–2, rm. 

N331, Rockville, MD 20855, 

240–276–8331, 

germaine.connolly@fda.hhs.gov 

Draft Guidance for Industry: Drug Residues Resulting From the Extralabel Use of Approved New Animal 

Drugs #186 

Deborah Cera, Center for Veterinary Medicine (HFV–235), Food 

and Drug Administration, 7519 

Standish Pl., Rockville, MD 

20855, 240–276–9209, deborah.cera@fda.hhs.gov 

Common or Usual Names for Animal Feed Ingredients and Their Use in Animal Feed (CPG 7126.08); 

Draft Compliance Policy Guide 

Sharon Benz, Center for Veterinary 

Medicine (HFV–220), Food and 

Drug Administration, 7519 Standish Pl., rm. 2648, Rockville, MD 

20855, 240–453–6864, 

esharon.benz@fda.hhs.gov 

Importation of New Animal Drugs by Licensed Veterinarians; Draft Compliance Policy Guide Nadine Steinberg, Center for Veterinary Medicine (HFV–200), 

Food and Drug Administration, 

MPN4, rm. 2658, Rockville, MD 

20855, 240–453–6846 nadine.steinberg@fda.hhs.gov 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices 46019 

Title of Guidance Contact 

Marketed Unapproved New Animal Drugs; Draft Compliance Policy Guide Nadine Steinberg, Center for Veterinary Medicine (HFV–200), 

Food and Drug Administration, 

MPN4, rm. 2658, Rockville, MD 

20855, 240–453–6846 nadine.steinberg@fda.hhs.gov 

VII. Office of the Commissioner 

Title/Topic of Guidance Contact 

Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked Questions—Statement of Investigator (Form FDA 1572) Patricia Beers Block, Office of the 

Commissioner (HF–34), Food 

and Drug Administration, 5600 

Fishers Lane, Rockville, MD 

20857, 301–827–3340, FAX: 

301–827–1169 

Guidance for Sponsors, Clinical Investigators, and IRBs; Data Retention When Subjects Voluntarily Withdraw from FDA-Regulated Clinical Trials Sara Goldkind, Office of the Commissioner (HF–34), Food and 

Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 

301–827–3340, FAX: 301–827–

1169 

Guidance for Sponsors, Clinical Investigators, and IRBs; A Guide to Informed Consent Marsha Melvin, Office of the Commissioner (HF–34), Food and 

Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 

301–827–3340, FAX: 301–827–

1169 

Guidance for Sponsors, Clinical Investigators, and IRBs; IRBs Continuing Review After Study Approval Carolyn Hommel, Office of the 

Commissioner (HF–34), Food 

and Drug Administration, 5600 

Fishers Lane, Rockville, MD 

20857, 301–827–3340, FAX: 

301–827–1169 

Final Guidance for Sponsors, Industry, Researchers, Investigators, and FDA Staff: Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance With Section 402(j) of 

the Public Health Service Act, Added by Title VII of the Food and Drug Administration Amendments Act 

of 2007 

Jarilyn Dupont, Office of Policy 

(HF–11), Food and Drug Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–

3360 

Final Guidance on Good Reprint Practices Do 

Guidance on Good Importer Practices Sharon Mayl, Office of Policy (HF–

11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–3360 

Guidance on Private Labs Phil Chao, Office of Policy (HF–23), 

Food and Drug Administration, 

5600 Fishers Lane, Rockville, 

MD 20857, 301–827–3360 


sroberts on PROD1PC70 with NOTICES
46020 Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices 

Dated: July 30, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–18126 Filed 8–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–M–0208] 

Medical Devices Regulated by the 

Center for Biologics Evaluation and 

Research; Availability of Summaries of 

Safety and Effectiveness Data for 

Premarket Approval Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of premarket approval applications 

(PMAs) that have been approved by the 

Center for Biologics Evaluation and 

Research (CBER). This list is intended to 

inform the public of the availability 

through the Internet and FDA’s Division 

of Dockets Management of summaries of 

safety and effectiveness data of 

approved PMAs. 

ADDRESSES: Submit written requests for 

copies of summaries of safety and 

effectiveness data to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Please include the appropriate docket 

number as listed in table 1 of this 

document when submitting a written 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the summaries of safety and 

effectiveness data. 

FOR FURTHER INFORMATION CONTACT: 

Tiffany Brown, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, suite 

200N, 1401 Rockville Pike, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 30, 

1998 (63 FR 4571), FDA published a 

final rule that revised 21 CFR 814.44(d) 

and 814.45(d) to discontinue individual 

publication of PMA approvals and 

denials in the Federal Register, 

providing instead to post this 

information on the Internet at http:// 

www.fda.gov. In addition, the 

regulations provide that FDA publish a 

quarterly list of available safety and 

effectiveness summaries of PMA 

approvals and denials that were 

announced during the quarter. FDA 

believes that this procedure expedites 

public notification of these actions 

because announcements can be placed 

on the Internet more quickly than they 

can be published in the Federal 

Register, and FDA believes that the 

Internet is accessible to more people 

than the Federal Register. 

In accordance with section 515(d)(4) 

and (e)(2) of the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 

360e(d)(4) and (e)(2)), notification of an 

order approving, denying, or 

withdrawing approval of a PMA will 

continue to include a notice of 

opportunity to request review of the 

order under section 515(g) of the act. 

The 30-day period for requesting 

administrative reconsideration of an 

FDA action under § 10.33(b) (21 CFR 

10.33(b)) for notices announcing 

approval of a PMA begins on the day the 

notice is placed on the Internet. Section 

10.33(b) provides that FDA may, for 

good cause, extend this 30-day period. 

Reconsideration of a denial or 

withdrawal of approval of a PMA may 

be sought only by the applicant; in these 

cases, the 30-day period will begin 

when the applicant is notified by FDA 

in writing of its decision. 

The following is a list of PMAs 

approved by CBER for which summaries 

of safety and effectiveness data were 

placed on the Internet from April 1, 

2008, through June 30, 2008. There were 

no denial actions during this period. 

The list provides the manufacturer’s 

name, the product’s generic name or the 

trade name, and the approval date. 

TABLE 1. LIST OF SUMMARIES OF SAFETY AND EFFECTIVENESS DATA FOR APPROVED PMAS MADE AVAILABLE APRIL 1, 

2008, THROUGH JUNE 30, 2008 

PMA No./Docket No. Applicant Trade Name Approval Date 

BP050051/0/FDA–2008–M–0208 Ortho-Clinical Diagnostics, 

Inc. 

VITROS Immunodiagnostics Products AntiHIV 1+2 Calibrator, and VITROS 

Immunodiagnostics Products Anti-HIV 

1+2 Reagent Pack 

March 27, 2008 

II.Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

www.fda.gov/cber/products.htm. 

Dated: July 29, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–18125 Filed 8–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0413] 

Draft Guidance for Industry on 

Residual Solvents in Drug Products 

Marketed in the United States; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Control of Residual 

Solvents in Drug Products Marketed in 

the United States.’’ On July 1, 2008, the 

United States Pharmacopeia (USP) 

published a new test requirement for the 

control of residual solvents, General 

Chapter <467> ‘‘Residual Solvents,’’

which replaced USP General Chapter 

<467> ‘‘Organic Volatile Impurities.’’

The change affects all compendial drug 

products marketed in the United States. 

This draft guidance reflects FDA’s 

recommendations on how to comply 

with those USP changes. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 


sroberts on PROD1PC70 with NOTICES