32476 Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices 

TABLE 1—ESTIMATED HOUR BURDEN AND COST FOR RECRUITMENT SUBSTUDY RESPONDENTS—STAGE 1—Continued 

[July 2010 to December 2010] 

Recruitment strategy/activity Type of respondent Number of 

respondents 

Responses 

per respondent 

Hours per 

response 

Annual hour 

burden 

Low-intensity CATI Questionnaire ........ Age-Eligible Women ............ 10,057 1 0 .5 5,028 

PPG Follow Up Script .......................... Age-Eligible Women ............ 10,057 6 0 .1 6,034 

Pregnancy Activities 

Low-intensity CATI Questionnaire ........ Pregnant Women ................. 518 1 0 .5 259 

Birth-Related Activities 

Low-intensity CATI Questionnaire ........ Mother/Baby ........................ 166 1 0 .5 83 

Total—Stage 1 .............................. .............................................. 97,598 ........................ .......................... 37,709 

Two Tier (High): 10 Study Locations Across Both Tiers—Projected for Stage 1 (July 2010–December 2010) 

Screening Activities 

Pregnancy Screening ........................... Age-Eligible Women ............ 15,840 1 0 .42 6,653 

Preconception Activities 

Pre-Pregnancy Interview ...................... Age-Eligible Women ............ 761 1 0 .75 571 

PPG Follow Up Script .......................... Age-Eligible Women ............ 761 6 0 .1 456 

Pregnancy Activities 

Women’s Informed Consent Form ....... Pregnant Women ................. 9,504 1 0 .67 6,368 

First Pregnancy Interview ..................... Pregnant Women ................. 3,552 1 1 3,552 

Second Pregnancy Interview ............... Pregnant Women ................. 3,552 1 0 .75 2,664 

Birth-Related Activities 

Birth Visit Interview ............................... Mother/Baby ........................ 1,857 1 0 .4 743 

Total—Stage 1 .............................. .............................................. 35,826 ........................ .......................... 21,006 

Grand Total, Recruitment 

Substudy.

.............................................. 334,308 ........................ .......................... 176,876 

The estimated annualized cost to 

respondents is $1,782,053 based on the 

differential hourly rate estimates in the 

above table. There are no Capital Costs 

to report. There are no Operating or 

Maintenance Costs to report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) Ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

Ways to minimize the burden of the 

collection of information on those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: 

Written comments and/or suggestions 

regarding the item(s) contained in this 

notice, especially regarding the 

estimated public burden and associated 

response time, should be directed to the: 

Office of Management and Budget, 

Office of Regulatory Affairs, New 

Executive Office Building, Room 10235, 

Washington, DC 20503, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact: Sarah L. 

Glavin, Ph.D., National Institute of 

Child Health and Human Development, 

31 Center Drive, Room 2A18, Bethesda, 

Maryland, 20892, or call non-toll free 

number (301) 496–1877, or e-mail your 

request, including your address to 

glavins@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30-days of the date of 

this publication. 

Dated: June 2, 2010. 

Sarah L. Glavin, 

NICHD Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2010–13705 Filed 6–7–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0250] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Premarket 

Approval of Medical Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

requirements for premarket approval of 

medical devices. 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 9, 2010. 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices 32477 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301 796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Premarket Approval of Medical 

Devices—21 CFR Part 814 /Food and 

Drug Administration Modernization 

Act of 1997 (FDAMA) Sections 201, 202, 

205, 208, and 209 (OMB Control 

Number 0910–0231)—Extension 

Section 515 of the Federal Food, Drug, 

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

360e) sets forth the requirements for 

premarket approval of certain class III 

medical devices. Class III devices are 

either pre-amendments devices that 

have been classified into class III, or 

post-amendments devices which are not 

substantially equivalent to a preamendments device, or transitional 

devices. Class III devices are devices 

such as implants, life sustaining or life 

supporting devices, and/or devices 

which otherwise present a potentially 

unreasonable risk of illness or injury, 

and/or are of substantial importance in 

preventing impairment of human 

health. Most premarket approval 

applications (PMAs) are for postamendments class III devices. 

Under section 515 of the act, an 

application must contain certain 

specific information, including full 

reports of all information concerning 

investigations showing whether the 

device is reasonably safe and effective. 

The application should also include a 

statement of components, ingredients, 

and properties of the principles of 

operation for such a device. In addition, 

the application should also include a 

full description of the methods used in, 

and the facilities and controls used for 

the manufacture and processing of the 

device and labeling specimens. The 

implementing regulations, contained in 

part 814 (21 CFR part 814), further 

specifies the contents of a PMA for a 

class III medical device and the criteria 

FDA sets forth in approving, denying, or 

withdrawing approval of a PMA as well 

as supplements to PMAs. The purpose 

of this regulation is to establish an 

efficient and thorough procedure for 

FDA’s review of PMAs and supplements 

to PMAs for certain class III (premarket 

approval) medical devices. The 

regulations under part 814 facilitate the 

approval of PMAs and supplements to 

PMAs for devices that have been shown 

to be reasonably safe and effective and 

otherwise meet the statutory criteria for 

approval. The regulations also ensure 

the disapproval of PMAs and 

supplements to PMAs for devices that 

have not been shown to be reasonably 

safe and effective and that do not 

otherwise meet the statutory criteria for 

approval. FDAMA (Public Law 105– 

115) was enacted on November 21, 

1997, to implement revisions to the act 

by streamlining the process of bringing 

safe and effective drugs, medical 

devices, and other therapies to the U.S. 

market. Several provisions of this act 

affect the PMA process, such as section 

515(d)(6) of the act. This section 

provided that PMA supplements were 

required for all device changes that 

affect safety and effectiveness of a 

device unless such changes are 

modifications to manufacturing 

procedures or method of manufacture. 

This type of manufacturing change now 

requires a 30-day notice, or where FDA 

finds such notice inadequate, a 135-day 

PMA supplement. 

To make the PMA process more 

efficient, in the past several years FDA 

has done the following: (1) Made 

changes to the PMA program based on 

comments received, (2) complied with 

changes to the program mandated by 

FDAMA and the Medical Device User 

Fee Modernization Act, and (3) worked 

toward completion of its PMA 

reinvention efforts. 

Respondents to this information 

collection are persons filing a PMA 

application or a PMA supplement with 

FDA for approval of certain class III 

medical devices. Part 814 defines a 

person as any individual, partnership, 

corporation, association, scientific or 

academic establishment, government 

agency or organizational unit, or other 

legal entity. These respondents include 

entities meeting the definition of 

manufacturers such as manufacturers of 

commercial medical devices in 

distribution prior to May 28, 1976 (the 

enactment date of the Medical Device 

Amendments). In addition, hospitals 

that reuse single use devices (SUDs) are 

also included in the definition of 

manufacturers. It is expected that FDA 

will receive one PMA application from 

hospitals that remanufacture SUDs 

annually. This figure has been included 

in table 1 of this document, as part of 

the reporting burden in § 814.20. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section/ 

FDAMA Section 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

814.15(b) 8 1 8 2 16 


emcdonald on DSK2BSOYB1PROD with NOTICES
32478 Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR Section/ 

FDAMA Section 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

814.20 36 1 36 668 24,048 

814.37(a) through (c) and (e) 36 1 36 167 6,012 

814.39(a) 670 1 670 60 40,200 

814.39(d) 68 1 68 6 408 

814.39(f) 505 1 505 16 8,080 

814.82(a)(9) 18 1 18 135 2,430 

814.84(b) 648 1 648 10 6,480 

Section 201 (FDAMA) Agreement 

Meeting 3 1 3 50 150 

Section 202 (FDAMA) Expedited 

Review Request 5 1 5 10 50 

Section 205 (FDAMA) Effectiveness 

Meeting 5 1 5 50 250 

Section 208 (FDAMA) Classification 

Panel Meetings 20 1 20 30 600 

Section 209 (FDAMA) 100-day 

meeting 28 1 28 10 280 

Totals 2,050 13 2,050 1,214 89,004 

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Recordkeeper Total Hours 

814.82(a)(5) and (a)(6) 698 1 698 17 11,866 

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

The industry-wide burden estimate 

for PMAs is based on an FDA actual 

average fiscal year (FY) annual rate of 

receipt of 36 PMA original applications, 

532 PMA supplements, and 505 30-day 

notices using FY 2005 through 2009 

data. The burden data for PMAs is based 

on data provided by manufacturers by 

device type and cost element in an 

earlier study. The specific burden 

elements for which FDA has data are as 

follows: 

• Clinical investigations—67 percent 

of total burden estimate; 

• Submission of additional data or 

information to FDA during a PMA 

review—12 percent; 

• Additional device development cost 

(e.g., testing)—10 percent; and 

• PMA and PMA supplement 

preparation and submissions, and 

development of manufacturing and 

controls data—11 percent. 

Reporting Burden 

The reporting burden can be broken 

out by certain sections of the PMA 

regulation as follows: 

• § 814.15—Research Conducted 

Outside the United States 

Approximately 20 percent of the 

clinical studies submitted in support of 

a PMA application are conducted 

outside the United States. Each study 

should be performed in accordance with 

the ‘‘Declaration of Helsinki’’ or the laws 

and regulations of the country in which 

the study was conducted. If the study 

was conducted in accordance with the 

laws of the country, the PMA applicant 

is required to explain to FDA in detail 

the differences between the laws of the 

country and the ‘‘Declaration of 

Helsinki.’’ Based on the number of 

PMAs received that contained studies 

from overseas, FDA estimates that the 

burden estimate necessary to meet this 

requirement is 20 hours. 

• Application in § 814.20(a) through 

(c) and (e) 

The majority of the 24,048 hourly 

burden estimate is due in part to this 

requirement. Included in this 

requirement are the conduct of 

laboratory and clinical trials as well as 

the analysis, review, and physical 

preparation of the PMA application. 

FDA estimates that 36 manufacturers, 

including hospital re-manufacturers of 

SUDs, will be affected by these 

requirements which are based on the 

actual average of FDA receipt of new 

PMA applications in FY 2005 through 

2009. FDA’s estimate of the hours per 

response (668) was derived through 

FDA’s experience and consultation with 

industry and trade associations. In 

addition, FDA also based its estimate on 

the results of an earlier study which 

accounts for the bulk of the hourly 

burden for this requirement, which is 

identified by manufacturers. 

• § 814.37—PMA Amendments and 

Resubmitted PMAs 

As part of the review process, FDA 

often requests PMA applicant to submit 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices 32479 

additional information regarding the 

device necessary for FDA to file the 

PMA or to complete its review and 

make a final decision. The PMA 

applicant may, also on their own 

initiative, submit additional information 

to FDA during the review process. 

These amendments contain information 

ranging from additional test results, reanalysis of the original data set to 

revised device labeling. Almost all 

PMAs received by the Agency have 

amendments submitted during the 

review process. FDA estimates that 

6,012 burden hours are necessary to 

satisfy this requirement. 

• PMA Supplements in § 814.39(a) 

FDA believes that the amendments 

mandated by FDAMA for § 814.39(f), 

permitting the submission of the 30-day 

notices in lieu of regular PMA 

supplements, will result in an 

approximate 20 percent reduction in the 

total number of hours as compared to 

regular PMA supplements. As a result, 

FDA estimates that 40,200 hours of 

burden are needed to complete the 

requirements for regular PMA 

supplements. 

• Special PMA Supplements— 

Changes Being Affected in § 814.39(d) 

These types of supplements are 

intended to enhance the safety of the 

device or the safe use of the device. The 

number of PMA supplements received 

that fit this category averaged 68 per 

year based on the numbers received 

from FY 2005 through FY 2009. Because 

of the minimal data required to be 

included in this type of supplement, 

FDA estimates that the burden hours 

necessary to satisfy this requirement are 

408 hours. 

• 30–Day Notice in § 814.39(f) 

Under section 515(d) of the act, 

modifications to manufacturing 

procedures or methods of manufacture 

that affect the safety and effectiveness of 

a device subject to an approved PMA do 

not require submission of a PMA 

supplement under § 814.39(a) and are 

eligible to be the subject of a 30-day 

notice. A 30-day notice shall describe in 

detail the change, summarize the data or 

information supporting the change, and 

state that the change has been made in 

accordance with the requirements of 

part 820 (21 CFR part 820). The 

manufacturer may distribute the device 

30 days after the date on which FDA 

receives the 30-day notice, unless FDA 

notifies the applicant within 30 days 

from receipt of the notice, that it is not 

adequate. FDA estimates the burden to 

satisfy this requirement is 8,080 hours. 

• Post-Approval Requirements in 

§ 814.82(a)(9) 

Post-approval requirements concern 

approved PMAs that were not 

reclassified and require a periodic 

report. After approval, all PMAs require 

a submission of an annual report. On 

average, approximately half of the 

submitted PMAs (18), require associated 

post-approval studies, i.e., followup of 

patients used in clinical trials to support 

the PMA or additional preclinical 

information, that is labor-intensive to 

compile and complete; the remaining 

PMAs require minimal information. 

Based on experience and consultation 

with industry, FDA has estimated that 

preparation of reports and information 

required by this section requires 2,430 

hours. 

• Reports in § 814.84(b) 

Post-approval requirements described 

in § 814.82(a)(7) require submission of 

an annual report for each approved 

PMA. FDA estimates that respondents 

will average about 10 hours in preparing 

their reports to meet this requirement. 

This estimate is based on FDA’s 

experience and consultation with 

industry. Thus, FDA estimates that the 

periodic reporting burden required by 

this section will take 6,480 hours. 

Statutory Reporting Burden Estimate 

(FDAMA) 

The total statutory reporting burden 

under the requirements of sections 201, 

202, 205, 208, and 209 of FDAMA is 

estimated to be 1,230 hours. This 

burden estimate was based on actual 

real and estimated FDA data tracked 

from FY 2005 through FY 2009, and an 

estimate was also derived to forecast 

future expectations with regard to this 

statutory data. 

Recordkeeping in § 814.82(a)(5) and 

(a)(6) 

The recordkeeping burden under this 

section requires the maintenance of 

records, used to trace patients and the 

organization and the indexing of records 

into identifiable files to ensure the 

device’s continued safety and 

effectiveness. These records are required 

only of those manufacturers who have 

an approved PMA and who had original 

clinical research in support of that 

PMA. For a typical year’s submissions, 

70 percent of the PMAs are eventually 

approved with 90 percent of these 

having original clinical trial data. 

Therefore, approximately 25 PMAs a 

year would be subject to these 

requirements. Also, because the 

requirements apply to all active PMAs, 

all holders of an active PMA application 

must maintain these records. 

PMAs have been required since 1976, 

and there are 698 active PMAs that 

could be subject to these requirements, 

based on actual FDA data. Each study 

has approximately 200 subjects, and at 

an average of 5 minutes per subject, 

there is a total burden per study of 1,000 

minutes, or 17 hours. The aggregate 

burden for all 698 holders of approved 

original PMAs, therefore, is 11,866 

hours. 

The applicant determines which 

records should be maintained during 

product development to document and/ 

or substantiate the device’s safety and 

effectiveness. Records required by the 

current good manufacturing practices 

for medical devices regulation (part 820) 

may be relevant to a PMA review and 

may be submitted as part of an 

application. In individual instances, 

records may be required as conditions of 

approval to ensure the device’s 

continuing safety and effectiveness. 

Dated: June 2, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–13763 Filed 6–7–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2009–E–0165 and FDA– 

2009–E–0169] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ABLAVAR 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

ABLAVAR (previously the trade name 

of the product was VASOVIST) and is 

publishing this notice of that 

determination as required by law. FDA 

has made the determination because of 

the submission of applications to the 

Director of Patents and Trademarks, 

Department of Commerce, for the 

extension of a patent which claims the 

human drug product. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

petitions along with three copies and 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 


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