Federal Register / Vol. 76, No. 59 / Monday, March 28, 2011 / Notices 17135 

1All guidance titles throughout this document 

reflect the style of the published versions. 

TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN 1

Form FDA No. Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

respondents 

Average burden 

per response 

(in Hours) 2

Total hours 

3519 ....................................................... 500 1 500 1/60 50 

3520 ....................................................... 500 1 500 1/60 50 

CFP Training Plan and Log ................... 500 3 1,500 1/60 150 

Total ................................................ .............................. .............................. .............................. .............................. 250 

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

2Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’. 

FDA bases its estimates of the number 

of respondents and the hours per 

response on its experience with the 

Program Standards over the past 3 years. 

As explained previously in this 

document, FDA estimates that 500 

regulatory jurisdictions will enroll in 

the Program Standards. FDA estimates a 

total of 12 minutes annually for each 

enrolled jurisdiction to complete both 

forms. FDA bases its estimate on the 

small number of data elements on the 

two forms and the ease of availability of 

the information. FDA estimates that, 

annually, 500 regulatory jurisdictions 

will submit one Form FDA 3519 for a 

total of 500 annual responses. Each 

submission is estimated to take 0.1 hour 

per response for a total of 50 hours. FDA 

estimates that, annually, 500 regulatory 

jurisdictions will submit one Form FDA 

3520 for a total of 500 annual responses. 

Each of these submissions is estimated 

to take 0.1 hour per response for a total 

of 50 hours. FDA estimates that, 

annually, 500 regulatory jurisdictions 

will submit three requests for 

documentation of successful completion 

of staff training using the CFP Training 

Plan and Log for a total of 1,500 annual 

responses. Each submission is estimated 

to take 0.1 hour per response for a total 

of 150 hours. Thus, the total reporting 

burden for this information collection is 

250 hours. 

Dated: March 23, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–7191 Filed 3–25–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0148] 

Clarifying Edits to Existing Special 

Controls Guidance Documents; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of updated special controls 

guidance documents for class II devices, 

which contain edits that reflect the 

Agency’s effort to clarify questions and 

confusion regarding its position on the 

binding nature of special controls 

guidance documents. The revised 

language does not change the Agency’s 

position or view, but rather is intended 

to clarify its position and remedy any 

possible confusion or 

misunderstanding. 

DATES: Submit either electronic or 

written comments on this document at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: See the SUPPLEMENTARY

INFORMATION section for electronic 

access to affected documents. 

Submit electronic comments on this 

document to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Philip Desjardins, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 5452, Silver Spring, 

MD 20993–0002, 301–796–5678; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In December 2008, FDA revised the 

cover sheet and standard language in 

newly issued special controls guidance 

documents to clarify the effect of a 

guidance that has been established as a 

special control (‘‘special controls 

guidance’’). In order to comply with the 

special controls guidance, 

manufacturers must address each 

identified risk to health presented in the 

guidance for the class II device by either 

meeting the recommendations of the 

guidance or by some other means that 

provides equivalent assurances of safety 

and effectiveness. 

FDA is now updating all preDecember 2008 special controls 

guidance documents with the revised 

standard language. Revisions to the 

special controls guidance documents 

include clarifying the statement of the 

special controls guidance document’s 

effect by replacing the standard 

language with the following statement: 

‘‘The firm must show that its device 

addresses the issues of safety and 

effectiveness identified in this guidance, 

either by meeting the recommendations 

of this guidance or by some other means 

that provides equivalent assurances of 

safety and effectiveness.’’ 

Special controls guidance documents 

on the following topics have been 

affected: 1

1. Acute Upper Airway Obstruction 

Devices, 

2. Clitoral Engorgement Devices, 

3. Anti-Saccharomyces cerevisiae (S. 

cerevisiae) Antibody (ASCA) Premarket 

Notifications, 

4. Shoulder Joint Metal/Polymer/ 

Metal Nonconstrained or SemiConstrained Porous-Coated Uncemented 

Prosthesis, 

5. B-Type Natriuretic Peptide 

Premarket Notifications, 

6. Home Uterine Activity Monitors, 

7. Pharmacy Compounding Systems, 

8. Tissue Culture Media for Human ex 

vivo Tissue and Cell Culture Processing 

Applications, 

9. Indwelling Blood Gas Analyzers, 

10. Ingestible Telemetric 

Gastrointestinal Capsule Imaging 

System, 

11. Premarket Notifications for 

Automated Differential Cell Counter for 

Immature or Abnormal Blood Cells, 

12. Medical Washers and Medical 

Washer-Disinfectors, 


Emcdonald on DSK2BSOYB1PROD with NOTICES
17136 Federal Register / Vol. 76, No. 59 / Monday, March 28, 2011 / Notices 

13. Endolymphatic Shunt Tube with 

Valve, 

14. Hip Joint Metal/Polymer 

Constrained Cemented or Uncemented 

Prosthesis, 

15. Apnea Monitors, 

16. Polymethylmethacrylate (PMMA) 

Bone Cement, 

17. Cyclosporine and Tacrolimus 

Assays, 

18. Transcutaneous Air Conduction 

Hearing Aid System (TACHAS), 

19. Intraoral Devices for Snoring and/ 

or Obstructive Sleep Apnea, 

20. Cutaneous Carbon Dioxide and 

Oxygen Monitors, 

21. Knee Joint Patellofemorotibial and 

Femorotibial Metal/Polymer PorousCoated Uncemented Prostheses, 

22. Optical Impression Systems for 

Computer Assisted Design and 

Manufacturing (CAD/CAM) of Dental 

Restorations, 

23. Resorbable Calcium Salt Bone 

Void Filler Device, 

24. Surgical Sutures, 

25. Breath Nitric Oxide Test, 

26. Breast Lesion Documentation 

System, 

27. Arrhythmia Detector and Alarm, 

28. Serological Reagents for the 

Laboratory Diagnosis of West Nile Virus, 

29. Endotoxin Assay, 

30. Dental Sonography and Jaw 

Tracking Devices, 

31. Human Dura Mater (applicable to 

dura mater recovered before May 25, 

2005), 

32. Hepatitis A Virus Serological 

Assays, 

33. Factor V Leiden DNA Mutation 

Detection Systems, 

34. Immunomagnetic Circulating 

Cancer Cell Selection and Enumeration 

System, 

35. Root-form Dental Implants and 

Endosseous Dental Implant Abutments, 

36. Dental Base Metal Alloys, 

37. Dental Noble Metal Alloys, 

38. Serological Assays for the 

Detection of Beta-Glucan, 

39. Sirolimus Test Systems, 

40. Newborn Screening Test Systems 

for Amino Acids, Free Carnitine, and 

Acylcarnitines Using Tandem Mass 

Spectrometry, 

41. Implantable Radiofrequency 

Transponder System for Patient 

Identification and Health Information, 

42. External Penile Rigidity Devices, 

43. Assisted Reproduction Laser 

Systems, 

44. Vascular and Neurovascular 

Embolization Devices, 

45. Drug Metabolizing Enzyme 

Genotyping System, 

46. Instrumentation for Clinical 

Multiplex Test Systems, 

47. Automated Fluorescence in situ 

Hybridization (FISH) Enumeration 

Systems, 

48. Dental Bone Grafting Material 

Devices, 

49. RNA Preanalytical Systems (RNA 

Collection, Stabilization and 

Purification Systems for RT–PCR used 

in Molecular Diagnostic Testing), 

50. Oral Rinse to Reduce the 

Adhesion of Dental Plaque, 

51. AFP–L3% Immunological Test 

Systems, 

52. CFTR Gene Mutation Detection 

System, 

53. Low Energy Ultrasound Wound 

Cleaner, 

54. Tinnitus Masker Devices, 

55. Labeling for Male Condoms Made 

of Natural Rubber Latex, 

56. Implantable Intra-Aneurysm 

Pressure Measurement System, 

57. Reagents for Detection of Specific 

Novel Influenza A Viruses, 

58. Topical Oxygen Chamber for 

Extremities, 

59. Olfactory Test Device, 

60. Fecal Calprotectin Immunological 

Test Systems, 

61. Absorbable Hemostatic Device, 

62. Quality Control Material for Cystic 

Fibrosis Nucleic Acid Assays, 

63. Oxygen Pressure Regulators and 

Oxygen Conserving Devices, 

64. Herpes Simplex Virus Types 1 and 

2 Serological Assays, 

65. Computerized Labor Monitoring 

Systems, 

66. Gene Expression Profiling Test 

System for Breast Cancer Prognosis, 

67. Intervertebral Body Fusion Device, 

68. Filtering Facepiece Respirator for 

Use by the General Public in Public 

Health Medical Emergencies, 

69. Absorbable Poly(hydroxybutyrate) 

Surgical Suture Produced by 

Recombinant DNA Technology, 

70. In Vitro Human 

Immunodeficiency Virus (HIV) Drug 

Resistance Genotype Assay, 

71. Electrocardiograph Electrodes, 

72. Remote Medication Management 

System, 

73. Automated Blood Cell Separator 

Device Operating by Centrifugal or 

Filtration Separation Principle, 

74. Plasmodium Species Antigen 

Detection Assays, 

75. Full Field Digital Mammography 

System, 

76. Certain Percutaneous 

Transluminal Coronary Angioplasty 

(PTCA) Catheters, 

77. Tissue Adhesive for the Topical 

Approximation of Skin, 

78. Bone Sonometers, 

79. Tissue Expander, 

80. Cord Blood Processing System and 

Storage Container. 

II. Electronic Access 

Persons interested in obtaining a copy 

of any revised special controls guidance 

document may do so by using the 

Internet. A search capability for all 

CDRH guidance documents is available 

at http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. To 

receive any affected CDRH guidance you 

may either send an email request to 

dsmica@fda.hhs.gov to receive an 

electronic copy of the document or send 

a fax request to 301–847–8149 to receive 

a hard copy. 

For CBER guidances, you may send a 

request to the Office of Communication, 

Outreach and Development (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448. 

The guidance may also be obtained by 

mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. In addition, 

CBER guidance documents are available 

at http://www.fda.gov/Biologics

BloodVaccines/GuidanceCompliance

RegulatoryInformation/default.htm. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Authority: 21 U.S.C. 371(h). 

Dated: March 23, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–7211 Filed 3–25–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2010–M–0519, FDA– 

2010–M–0556, FDA–2010–M–0558, FDA– 

2010–M–0557, and FDA–2010–M–0591] 

Medical Devices; Availability of Safety 

and Effectiveness Summaries 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 


Emcdonald on DSK2BSOYB1PROD with NOTICES