16214 Federal Register / Vol. 74, No. 67 / Thursday, April 9, 2009 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

ACF–196TR ..................................................................................................... 3 4 8 96 

Estimated Total Annual Burden 

Hours: 96. 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: April 06, 2009. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E9–8058 Filed 4–8–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Financial Status Reporting Form 

for State Councils on Developmental 

Disabilities Program. 

OMB No.: 0980–0212. 

Description: For the program of the 

State Councils on Developmental 

Disabilities, funds are awarded to State 

agencies contingent on fiscal 

requirements in subtitle B of the 

Developmental Disabilities Assistance 

and Bill of Rights Act. The SF–269, 

ordinarily mandated in the revised OMB 

Circular A–102, provides no accounting 

breakouts necessary for proper 

stewardship. Consequently, the 

proposed streamlined form will 

substitute for the SF–269 and will allow 

compliance monitoring and proactive 

compliance maintenance and technical 

assistance. 

Respondents: State Councils and 

Designated State Agencies. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Financial Status Reporting Form for State Councils on Developmental Disabilities Program .......................................................................................... 55 3 5.10 841.50 

Estimated Total Annual Burden 

Hours: 841.50. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–6974, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: April 6, 2009. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E9–8123 Filed 4–8–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–M–0101] 

Medical Devices; Order for Certain 

Class III Devices; Submission of Safety 

and Effectiveness Information 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order requiring manufacturers of 

remaining preamendments class III 

devices for which regulations requiring 

submission of premarket approval 

applications (PMAs) have not been 

issued to submit to FDA a summary of, 


dwashington3 on PROD1PC60 with NOTICES
Federal Register / Vol. 74, No. 67 / Thursday, April 9, 2009 / Notices 16215 

and a citation to, any information 

known or otherwise available to them 

respecting such devices, including 

adverse safety or effectiveness 

information concerning the devices 

which has not been submitted under the 

Federal Food, Drug, and Cosmetic Act 

(the act). FDA is requiring the 

submission of this information in order 

to determine, for each device, whether 

the classification of the device should 

be revised to require the submission of 

a PMA or a notice of completion of a 

Product Development Protocol (PDP), or 

whether the device should be 

reclassified into class I or II. 

DATES: Summaries and citations must be 

submitted by August 7, 2009. 

ADDRESSES: Submit paper copies of 

summaries and citations to the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, rm. 1061, Rockville, MD 

20852. Submit electronic copies of 

summaries and citations to http:// 

www.regulations.gov. Identify 

summaries and citations with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Sarah K. Morabito, Center for Devices 

and Radiological Health (HFZ–402), 

Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–3975. 

SUPPLEMENTARY INFORMATION: 

I. Background—Regulatory Authorities 

The act (21 U.S.C. 301 et seq.), as 

amended by the Medical Device 

Amendments of 1976 (the 1976 

amendments) (Public Law 94–295), the 

Safe Medical Devices Act (SMDA) 

(Public Law 101–629), the Food and 

Drug Administration Modernization Act 

of 1997 (Public Law 105–115), the 

Medical Device User Fee and 

Modernization Act of 2002 (Public Law 

107–250), the Medical Devices 

Technical Corrections Act (Public Law 

108–214), and the Food and Drug 

Administration Amendments Act of 

2007 (Public Law 110–85), establishes a 

comprehensive system for the regulation 

of medical devices intended for human 

use. Section 513 of the act (21 U.S.C. 

360c) requires the classification of 

medical devices into one of three 

regulatory classes: Class I (general 

controls), class II (special controls), or 

class III (premarket approval). 

Generally, devices that were on the 

market before May 28, 1976, the date of 

enactment of the 1976 amendments, and 

devices marketed on or after that date 

that are substantially equivalent to such 

devices, have been classified by FDA. 

This order refers to both the class III 

devices that were on the market before 

May 28, 1976, and the devices found to 

be substantially equivalent to them that 

were marketed on or after that date, as 

‘‘preamendments devices.’’ 

Section 515(b)(1) of the act (21 U.S.C. 

360e(b)(1)) establishes the requirement 

that a preamendments device that FDA 

has classified into class III is subject to 

premarket approval. However, 

submission of a PMA (or a notice of 

completion of a PDP) is not required 

until 90 days after FDA promulgates a 

final rule requiring premarket approval 

for the device, or 30 months after final 

classification of the device, whichever is 

later. See section 501(f)(2)(B) of the act 

(21 U.S.C. 351(f)(2)(B)). The device may, 

however, be distributed only for 

investigational use if the manufacturer, 

importer, or other sponsor of the device 

complies with the investigational device 

exemption (IDE) requirements. 

The SMDA changed the definition of 

class II devices from those for which a 

performance standard is necessary to 

provide reasonable assurance of safety 

and effectiveness to those for which 

there is sufficient information to 

establish special controls to provide 

such assurance. Special controls include 

performance standards, postmarket 

surveillance, patient registries, 

guidelines (including guidelines for the 

submission of clinical data in premarket 

notification submissions in accordance 

with section 510(k) of the act (21 U.S.C. 

360(k))), recommendations, and other 

appropriate actions the agency deems 

necessary to provide such assurance. 

Thus, the SMDA modified the definition 

of class II devices to permit reliance on 

special controls, rather than 

performance standards alone, to provide 

reasonable assurance of safety and 

effectiveness. 

The SMDA also added section 515(i) 

(21 U.S.C. 360e(i)) to the act. This 

section requires FDA to order 

manufacturers of preamendments class 

III devices for which no final regulation 

has been issued requiring the 

submission of PMAs to submit to the 

agency a summary of, and a citation to, 

any information known or otherwise 

available to them respecting such 

devices, including adverse safety and 

effectiveness information that has not 

been submitted under section 519 of the 

act (21 U.S.C. 360i). Section 519 of the 

act requires manufacturers, importers, 

and distributors to maintain records and 

to report information that reasonably 

suggests that one of its marketed devices 

may have caused or contributed to a 

death or serious injury or that a 

malfunction of the device is likely to 

cause death or serious injury on 

recurrence. Section 515(i) of the act also 

directs FDA to either revise the 

classification of the device into class I 

or class II or require the device to 

remain in class III; and for devices 

remaining in class III, to establish a 

schedule for the promulgation of a rule 

requiring the submission of PMAs for 

the device. 

In the Federal Register of May 6, 1994 

(59 FR 23731), FDA announced the 

availability of a notice setting forth its 

strategy for addressing the remaining 

class III preamendments devices. Of the 

approximately 149 preamendments 

devices FDA initially classified or 

proposed to classify into class III (48 FR 

40272, September 6, 1983), FDA has 

either reclassified into class I or II, or 

issued regulations requiring the 

submission of PMAs for, all but 27 

devices. Of the 27 devices, 25 are the 

subject of this notice. The two 

remaining devices, Herpes simplex 

virus serological assays (21 CFR 

866.3305) and Topical oxygen chamber 

for extremities (21 CFR 878.5650), will 

be addressed in separate orders. 

II. Statutory Authority and 

Enforcement 

In addition to the provisions of 

section 515(i) of the act described in 

section I of this document, this order is 

issued under section 519 of the act, as 

implemented by § 860.7(g)(2) (21 CFR 

860.7(g)(2)). Section 860.7(g)(2) 

authorizes FDA to require reports or 

other information bearing on the 

classification of a device. Section 519 of 

the act also requires the reporting of any 

death or serious injury caused by a 

device or by its malfunction. 

Failure to comply with this order 

results in the device being misbranded 

under section 502(t) of the act (21 U.S.C. 

352(t)) and is a prohibited act under 

sections 301(a) and (q) of the act (21 

U.S.C. 331(a) and (q)). The agency will 

use its enforcement powers to deter 

noncompliance. Violations of section 

301 of the act may be subject to seizure 

or injunction under sections 302(a) and 

304(a) of the act (21 U.S.C. 332(a) and 

334(a)). In addition, violations under 

section 301 of the act may be subject to 

civil penalties under section 303(f) of 

the act (21 U.S.C. 333(f)) and criminal 

prosecution under section 303(a) of the 

act (21 U.S.C. 333(a)). 

III. Order 

The agency is hereby issuing this 

order under sections 515(i) and 519 of 

the act and § 860.7(g)(1) of the 

regulations. Under the order, the 

required information must be submitted 

by the date set forth in this document 

(see DATES) so that FDA may begin the 

process established by section 515(i) of 


dwashington3 on PROD1PC60 with NOTICES
16216 Federal Register / Vol. 74, No. 67 / Thursday, April 9, 2009 / Notices 

the act to either reclassify these devices 

into class I or II or initiate rulemaking 

to require submission of PMAs or PDPs 

for them. FDA does not anticipate 

extending the time for submitting the 

required information. 

For the following 25 devices, the 

required information must be submitted 

by August 7, 2009. 

1. 21 CFR 868.5610 Membrane lung 

for long-term pulmonary support. 

2. 21 CFR 870.3535 Intra-aortic 

balloon and control system. 

3. 21 CFR 870.3545 Ventricular 

bypass (assist) device. 

4. 21 CFR 870.3600 External 

pacemaker pulse generator. 

5. 21 CFR 870.3610 Implantable 

pacemaker pulse generator. 

6. 21 CFR 870.3680(b) Cardiovascular 

permanent pacemaker electrode. 

7. 21 CFR 870.3700 Pacemaker 

programmers. 

8. 21 CFR 870.3710 Pacemaker repair 

or replacement material. 

9. 21 CFR 870.4360 Nonroller-type 

cardiopulmonary bypass blood 

pump. 

10. 21 CFR 870.5200 External cardiac 

compressor. 

11. 21 CFR 870.5225 External counterpulsating device. 

12. 21 CFR 870.5310 Automated 

external defibrillator. 

13. 21 CFR 872.3640(b)(2) Endosseous 

dental implant (blade form). 

14. 21 CFR 872.3960 Mandibular 

condyle prosthesis (temporary 

implant). 

15. 21 CFR 876.5540(b)(1) Implanted 

blood access device. 

16. 21 CFR 876.5870 Sorbent 

hemoperfusion system. 

17. 21 CFR 882.5800 Cranial 

electrotherapy stimulator. 

18. 21 CFR 882.5940 

Electroconvulsive therapy device. 

19. 21 CFR 884.5330 Female condom. 

20. 21 CFR 888.3070(b)(2) Pedicle 

screw spinal system (certain uses). 

21. 21 CFR 888.3320 Hip joint metal/ 

metal semi-constrained, with a 

cemented acetabular component, 

prosthesis. 

22. 21 CFR 888.3330 Hip joint metal/ 

metal semi-constrained, with an 

uncemented acetabular component, 

prosthesis. 

23. 21 CFR 890.5290(b) Shortwave 

diathermy (certain uses). 

24. 21 CFR 890.5525(b) Iontophoresis 

device (certain uses). 

25. 892.1990 Transilluminator for 

breast evaluation. 

Required Contents of Submissions 

By the date listed in the DATES section 

of this document, all manufacturers 

currently marketing the preamendments 

class III devices subject to this order 

shall provide a summary of, and citation 

to, any information known or otherwise 

available to them respecting the devices, 

including adverse safety and 

effectiveness data that has not been 

submitted under section 519 of the act. 

FDA suggests that it may be in the best 

interest of submitters to summarize the 

information submitted under section 

519 of the act to facilitate FDA’s 

decisionmaking. 

The information should be submitted 

in one of the two following formats 

depending on whether the manufacturer 

is aware of information that would 

support the reclassification of the device 

into class I (general controls) or class II 

(special controls). Information that 

would support the reclassification of the 

device must consist of adequate, valid 

scientific evidence showing that general 

controls alone, or general controls along 

with special controls, will provide a 

reasonable assurance of the safety and 

effectiveness of the device. 

If a manufacturer is not aware of 

information that would support the 

reclassification of its device into class I 

or class II, the information should be 

submitted in the following format: 

1. Indications for use. A general 

description of the disease or condition 

to be diagnosed, treated, cured, 

mitigated, or prevented, including a 

description of the patient population for 

which the device is intended. 

2. Device description. An explanation 

of how the device functions, significant 

physical and performance 

characteristics of the device, and basic 

scientific concepts that form the basis 

for the device. 

3. Other device labeling. Other device 

labeling that includes contraindications, 

warnings and precautions and/or 

promotional materials. 

4. Risks. A summary of all adverse 

safety and effectiveness information and 

identification of the risks presented by 

the device as well as any mechanisms 

or procedures which will control the 

risk. 

5. Alternative practices and 

procedures. A description of alternative 

practices or procedures for diagnosing, 

treating, preventing, curing, or 

mitigating the disease or condition for 

which the device is intended. 

6. Summary of preclinical and 

clinical data. The summary of 

preclinical and clinical data should 

include the conclusions drawn from the 

studies that support the safety and 

effectiveness of the device, and that 

address the adverse effects of the device 

on health. The summary should include 

a brief description of the objective of the 

studies, the experimental design, how 

the data were collected and analyzed, 

and a brief description of the results of 

the studies, whether positive, negative, 

or inconclusive. The summary of the 

clinical study should also include a 

discussion of the subject inclusion and 

exclusion criteria, the study population, 

reasons for patient discontinuations, 

and results of statistical analyses. 

7. Bibliography. A copy of each key 

reference, a brief summary of the salient 

features of each key reference, and a 

brief discussion of why the reference is 

relevant to an evaluation of the safety 

and effectiveness of the device. 

Any manufacturer who is aware of 

information that would support the 

reclassification of its device into class I 

or class II may either submit 

information using the format described 

below or may submit a formal 

reclassification petition, which as 

described in 21 CFR 860.123(a)(3) and 

(a)(4), should include: 

1. Identification. A brief narrative 

identification of the device. This 

identification should be specific enough 

to distinguish a particular device from 

a generic type of device. Where 

appropriate, this identification should 

include a listing of the materials, and 

the component parts, and a description 

of the intended use of the device. 

2. Risks to health. An identification of 

the risks to health. This section should 

summarize all adverse safety and 

effectiveness information that has not 

been submitted under section 519 of the 

act, particularly the most significant 

information. The mechanisms or 

procedures that will control the risk 

should be described. A list of the 

general hazards associated with the 

device and a bibliography with copies of 

the referenced material should be 

provided. 

3. Recommendation. A statement 

whether the manufacturer believes the 

device should be reclassified into class 

I or class II. 

4. Summary of reasons for 

recommendation. Each manufacturer 

should include a summary of the 

reasons for requesting reclassification of 

its device and an explanation of why it 

believes the device meets the statutory 

criteria for reclassification into class I or 

class II. Each manufacturer should also 

identify the special controls that it 

believes would be sufficient to provide 

reasonable assurance of the safety and 

effectiveness of its device if it believes 

the device should be reclassified into 

class II. 

5. Summary of valid scientific 

evidence on which the recommendation 

is based. Manufacturers are advised 

that, when considering a formal 

reclassification petition, FDA will rely 


dwashington3 on PROD1PC60 with NOTICES
Federal Register / Vol. 74, No. 67 / Thursday, April 9, 2009 / Notices 16217 

1OCRA Student Rate applies to those individuals 

enrolled in a Regulatory or Quality related 

academic program at an accredited institution. 

Proof of enrollment required. 

only upon valid scientific evidence to 

determine whether there is reasonable 

assurance of the safety and effectiveness 

of the device, if regulated by general 

controls alone (class I) or by general 

controls and special controls (class II). 

Valid scientific evidence consists of 

evidence from well-controlled 

investigations, partially controlled 

studies, studies and objective trials 

without matched controls, welldocumented case histories conducted by 

qualified experts, and reports of 

significant human experience with a 

marketed device, from which it can 

fairly and responsibly be concluded by 

qualified experts that there is reasonable 

assurance of the safety and effectiveness 

of a device under its conditions of use. 

The evidence required may vary 

according to the characteristics of the 

device, its conditions of use, the 

existence and adequacy of warnings and 

other restrictions, and the extent of 

experience with its use. Isolated case 

reports, random experience, reports 

lacking sufficient details to permit 

scientific evaluation, and 

unsubstantiated opinions are not 

regarded as valid scientific evidence to 

show safety or effectiveness (see 

§ 860.7(c)(2)). 

According to § 860.7(d)(1), there is 

reasonable assurance that a device is 

safe when it can be determined, based 

upon valid scientific evidence, that the 

probable benefits to health from use of 

the device for its intended uses and 

conditions of use, when accompanied 

by adequate directions and warnings 

against unsafe use, outweigh any 

probable risks. The valid scientific 

evidence used to determine the safety of 

a device shall adequately demonstrate 

the absence of unreasonable risk of 

illness or injury associated with the use 

of the device for its intended uses and 

conditions for use. Moreover, under 

§ 860.7(e)(1), there is reasonable 

assurance that a device is effective when 

it can be determined, based upon valid 

scientific evidence, that in a significant 

portion of the target population, the use 

of the device for its intended uses and 

conditions of use, when accompanied 

by adequate directions for use and 

warnings against unsafe use, will 

provide clinically significant results. 

IV. Submission of Required Information 

The summary of, and citation to, any 

information required by the act must be 

submitted by the dates listed in the 

DATES section of this document to the 

Division of Dockets Management (see 

ADDRESSES). 

V. Paperwork Reduction Act of 1995 

This order refers to collections of 

information necessary to comply with 

the requirements found in sections 

510(k) of the act (21 U.S.C. 360(k)) and 

21 CFR part 807, subpart E or the 

requirements of 515(b) of the act (21 

U.S.C. 360e(b)), 21 CFR part 860, and 21 

CFR part 814. These collections of 

information are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

collections of information in 21 CFR 

860.123 have been approved under 

OMB control number 0910–0138; the 

collections of information in 21 CFR 

part 814, have been approved under 

OMB control number 0910–0231; and 

the collections of information in 21 CFR 

part 807, subpart E have been approved 

under OMB control number 0910–0120. 

Dated: April 2, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–8022 Filed 4–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

The 12th Annual Food and Drug 

Administration-Orange County 

Regulatory Affairs Educational 

Conference; ‘‘Regulatory Affairs: The 

Challenges of Ensuring Product 

Safety’’ 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting. 

The Food and Drug Administration 

(FDA) is announcing the following 

conference: 12th Annual Educational 

Conference co-sponsored with the 

Orange County Regulatory Affairs 

Discussion Group (OCRA). The 

conference is intended to provide the 

Drug, Device, and Biologics industries 

with an opportunity to interact with 

FDA reviewers and compliance officers 

from the Centers and District Offices, as 

well as other industry experts. The main 

focus of this interactive conference will 

be product approval, compliance, and 

risk management in the three medical 

product areas. Industry speakers, 

interactive questions and answers, and 

workshop sessions will also be included 

to assure open exchange and dialogue 

on the relevant regulatory issues. 

Date and Time: The conference will 

be held on June 9 and 10, 2009, from 

7:30 a.m. to 5 p.m. 

Location: The conference will be held 

at the Irvine Marriott Hotel, 18000 Von 

Karman Ave., Irvine, CA 92612. 

Contact: Linda Hartley, Food and 

Drug Administration, 19701 Fairchild, 

Irvine, CA 92612, 949–608–4413, FAX: 

949–608–4417, or OCRA, Attention to 

Detail, 5319 University Dr., suite 641, 

Irvine, CA 92612, 949–387–9046, FAX: 

949–387–9047, Web site: http:// 

www.ocra-dg.org. 

Registration and Meeting Information: 

See OCRA Web site, http://www.ocradg.org. Contact Attention to Detail at 

949–387–9046. 

Before May 8, 2009, registration fees 

are as follows: $675.00 for members, 

$725.00 for nonmembers and $475.00 

for FDA/Govt/Students.1 After May 8, 

2009, $725.00 for members, $775.00 for 

nonmembers, and $475.00 for FDA/ 

Govt/Students.1

The registration fee will cover actual 

expenses including refreshments, lunch, 

materials, parking, and speaker 

expenses. 

If you need special accommodations 

due to a disability, please contact Linda 

Hartley at least 10 days in advance. 

Dated: April 6, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–8135 Filed 4–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Office on (301) 443– 

1129. 

The following request has been 

submitted to the Office of Management 


dwashington3 on PROD1PC60 with NOTICES