63834 Federal Register / Vol. 75, No. 200 / Monday, October 18, 2010 / Notices 

TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS

Instrument(s) tested Frequency of 

response 

Average time per 

response 

(minutes/hour) 

Number of 

respondents 

Annual hour 

burden 

Read Invitation (Attachments 3) .............................................. 1.00 1/60 (0.017) 16,667.00 278 

Pre-Enrollment (Attachment 6) ................................................ 1.00 10/60 (0.167) 2,312.00 385 

Enrollment Process (Attachment 7) ......................................... 1.00 5/60 (0.083) 2,288.00 191 

ASA24 (Attachments 4–1) ....................................................... 2.00 30/60 (0.500) 1,944.00 1,944 

ACT–24 (Attachments 4–2) ..................................................... 2.00 15/60 (0.250) 1,944.00 972 

LHQ (Attachments 4–3) ........................................................... 1.00 20/60 (0.333) 1,944.00 648 

DHQ (Attachments 4–4) .......................................................... 1.00 45/60 (0.750) 1,944.00 1,458 

Web Re-entry (Attachment 8) .................................................. 6.00 5/60 (0.083) 1,944.00 972 

Evaluation Survey (Attachment 9) ........................................... 1.00 1/60 (0.017) 2,288.00 38 

Totals ................................................................................ .............................. .............................. 33,275.00 6,886 

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) Evaluate 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) Evaluate 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) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) 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: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Arthur Schatzkin, 

M.D., Dr.P.H, Chief, Nutritional 

Epidemiology Branch, Division of 

Cancer Epidemiology and Genetics, 

National Cancer Institute, NIH, DHHS, 

Executive Plaza South, Room 3040, 

6120 Executive Blvd., EPS–MSC 7242, 

Bethesda, MD 20892–7335 or call nontoll-free number 301–594–2931 or email your request, including your 

address to: schatzka@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: October 12, 2010. 

Vivian Horovitch-Kelley, 

NCI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2010–26187 Filed 10–15–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0273] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practice Quality System 

Regulations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by November 

17, 2010. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0073. Also 

include the FDA 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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Medical Devices: Current Good 

Manufacturing Practice Quality System 

Regulations—21 

CFR Part 820 (OMB Control Number 

0910–0073)—Extension 

Under section 520(f) of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C act) (21 U.S.C. 360j(f)), the 

Secretary of the Department of Health 

and Human Services has the authority 

to prescribe regulations requiring that 

the methods used in, and the facilities 

and controls used for, the manufacture, 

preproduction design validation 

(including a process to assess the 

performance of a device but not 

including an evaluation of the safety 

and effectiveness of a device), packing, 

storage, and installation of a device 

conform to current good manufacturing 

practice (CGMP), as described in such 

regulations, to assure that the device 

will be safe and effective and otherwise 

in compliance with the act. 

The CGMP/quality system (QS) 

regulation implementing authority 

provided by this statutory provision is 

found under part 820 (21 CFR part 820) 

and sets forth basic CGMP requirements 

governing the design, manufacture, 

packing, labeling, storage, installation, 

and servicing of all finished medical 

devices intended for human use. The 

authority for this regulation is covered 

under sections 501, 502, 510, 513, 514, 

515, 518, 519, 520, 522, 701, 704, 801, 

and 803 of the FD&C act (21 U.S.C. 351, 

352, 360, 360c, 360d, 360e, 360h, 360i, 

360j, 360l, 371, 374, 381, and 383). The 

CGMP/QS regulation includes 

requirements for purchasing and service 

controls, clarifies recordkeeping 

requirements for device failure and 

complaint investigations, clarifies 

requirements for verifying/validating 

production processes and process or 

product changes, and clarifies 

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Federal Register / Vol. 75, No. 200 / Monday, October 18, 2010 / Notices 63835 

requirements for product acceptance 

activities quality data evaluations and 

corrections of nonconforming product/ 

quality problems. 

Requirements are compatible with 

specifications in the international 

standards ‘‘ISO 9001: Quality Systems 

Model for Quality Assurance in Design/ 

Development, Production, Installation, 

and Servicing.’’ The CGMP/QS 

information collections will assist FDA 

inspections of manufacturers for 

compliance with QS requirements 

encompassing design, production, 

installation, and servicing processes. 

Section 820.20(a) through (e) requires 

management with executive 

responsibility to establish, maintain, 

and/or review the following topics: 

(1) The quality policy, (2) the 

organizational structure, (3) the quality 

plan, and (4) the quality system 

procedures of the organization. 

Section 820.22 requires the conduct 

and documentation of QS audits and reaudits. Section 820.25(b) requires the 

establishment of procedures to identify 

training needs and documentation of 

such training. 

Section 820.30(a)(1) and (b) through 

(j), requires in respective order, the 

establishment, maintenance, and/or 

documentation of the following topics: 

(1) Procedures to control design of class 

III and class II devices and certain class 

I devices as listed therein; (2) plans for 

design and development activities and 

updates; (3) procedures identifying, 

documenting, and approving design 

input requirements; (4) procedures 

defining design output, including 

acceptance criteria, and documentation 

of approved records; (5) procedures for 

formal review of design results and 

documentation of results in the design 

history file (DHF); (6) procedures for 

verifying device design and 

documentation of results and approvals 

in the DHF; (7) procedures for validating 

device design, including documentation 

of results in the DHF; (8) procedures for 

translating device design into 

production specifications; (9) 

procedures for documenting, verifying, 

and validating approved design changes 

before implementation of changes; and 

(10) the records and references 

constituting the DHF for each type of 

device. 

Section 820.40 requires manufacturers 

to establish and maintain procedures 

controlling approval and distribution of 

required documents and document 

changes. 

Section 820.40(a) and (b) requires the 

establishment and maintenance of 

procedures for the review, approval, 

issuance, and documentation of 

required records (documents) and 

changes to those records. 

Section 820.50(a)(1), (a)(2), (a)(3), and 

(b) requires the establishment and 

maintenance of procedures and 

requirements to ensure service and 

product quality, records of acceptable 

suppliers, and purchasing data 

describing specified requirements for 

products and services. 

Sections 820.60 and 820.65 require, 

respectively, the establishment and 

maintenance of procedures for 

identifying all products from receipt to 

distribution and for using control 

numbers to track surgical implants and 

life-sustaining or supporting devices 

and their components. 

Section 820.70(a)(1) through (a)(5), (b) 

through (e), (g)(1) through (g)(3), (h), and 

(i) requires the establishment, 

maintenance, and/or documentation of 

the following topics: (1) Process control 

procedures; (2) procedures for verifying 

or validating changes to specification, 

method, process, or procedure; (3) 

procedures to control environmental 

conditions and inspection result 

records; (4) requirements for personnel 

hygiene; (5) procedures for preventing 

contamination of equipment and 

products; (6) equipment adjustment, 

cleaning, and maintenance schedules; 

(7) equipment inspection records; (8) 

equipment tolerance postings, 

procedures for utilizing manufacturing 

materials expected to have an adverse 

effect on product quality; and (9) 

validation protocols and validation 

records for computer software and 

software changes. 

Sections 820.72(a), (b)(1), and (b)(2) 

and 820.75(a) through (c) require, 

respectively, the establishment, 

maintenance, and/or documentation of 

the following topics: (1) Equipment 

calibration and inspection procedures; 

(2) national, international or in-house 

calibration standards; (3) records that 

identify calibrated equipment and next 

calibration dates; (4) validation 

procedures and validation results for 

processes not verifiable by inspections 

and tests; (5) procedures for keeping 

validated processes within specified 

limits; (6) records for monitoring and 

controlling validated processes; and (7) 

records of the results of revalidation 

where necessitated by process changes 

or deviations. 

Sections 820.80(a) through (e) and 

820.86, respectively, require the 

establishment, maintenance, and/or 

documentation of the following topics: 

(1) Procedures for incoming acceptance 

by inspection, test, or other verification; 

(2) procedures for ensuring that in 

process products meet specified 

requirements and the control of product 

until inspection and tests are 

completed; (3) procedures for, and 

records that show, incoming acceptance 

or rejection is conducted by inspections, 

tests or other verifications; (4) 

procedures for, and records that show, 

finished devices meet acceptance 

criteria and are not distributed until 

device master record (DMR) activities 

are completed; (5) records in the device 

history record (DHR) showing 

acceptance dates, results, and 

equipment used; and (6) the acceptance/ 

rejection identification of products from 

receipt to installation and servicing. 

Sections 820.90(a), (b)(1), and (b)(2) 

and 820.100 require, respectively, the 

establishment, maintenance and/or 

documentation of the following topics: 

(1) Procedures for identifying, 

recording, evaluating, and disposing of 

nonconforming product; (2) procedures 

for reviewing and recording concessions 

made for, and disposition of, 

nonconforming product; (3) procedures 

for reworking products, evaluating 

possible adverse rework effect and 

recording results in the DHR; (4) 

procedures and requirements for 

corrective and preventive actions, 

including analysis, investigation, 

identification and review of data, 

records, causes, and results; and (5) 

records for all corrective and preventive 

action activities. 

Section 820.100(a)(1) through (a)(7) 

states that procedures and requirements 

shall be established and maintained for 

corrective/preventive actions, including 

the following: (1) Analysis of data from 

process, work, quality, servicing 

records; investigation of 

nonconformance causes; (2) 

identification of corrections and their 

effectiveness; (3) recording of changes 

made; and (4) appropriate distribution 

and managerial review of corrective and 

preventive action information. Section 

820.120 states that manufacturers shall 

establish/maintain procedures to control 

labeling storage/application; and 

examination/release for storage and use, 

and document those procedures. 

Sections 820.120(b) and (d), 820.130, 

820.140, 820.150(a) and (b), 820.160(a) 

and (b), and 820.170(a) and (b), 

respectively, require the establishment, 

maintenance, and/or documentation of 

following topics: (1) Procedures for 

controlling and recording the storage, 

examination, release, and use of 

labeling; (2) the filing of labels/labeling 

used in the DHR; (3) procedures for 

controlling product storage areas and 

receipt/dispatch authorizations; (4) 

procedures controlling the release of 

products for distribution; (5) 

distribution records that identify 

consignee, product, date, and control 

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63836 Federal Register / Vol. 75, No. 200 / Monday, October 18, 2010 / Notices 

numbers; and (6) instructions, 

inspection and test procedures that are 

made available, and the recording of 

results for devices requiring installation. 

Sections 820.180(b) and (c), 

820.181(a) through (e), 820.184(a) 

through (f), and 820.186 require, 

respectively, the maintenance of records 

that are: (1) Retained at prescribed 

site(s), made readily available and 

accessible to FDA and retained for the 

device’s life expectancy or for 2 years; 

(2) contained or referenced in a DMR 

consisting of device, process, quality 

assurance, packaging and labeling, and 

installation, maintenance, and servicing 

specifications and procedures; (3) 

contained in a DHR and demonstrate the 

manufacture of each unit, lot, or batch 

of product in conformance with DMR 

and regulatory requirements, include 

manufacturing and distribution dates, 

quantities, acceptance documents, 

labels and labeling, control numbers; 

and (4) contained in a quality system 

record (QSR), consisting of references, 

documents, procedures, and activities 

not specific to particular devices. 

Sections 820.198(a) through (c) and 

820.200(a) through (d), respectively, 

require the establishment, maintenance, 

and/or documentation of the following 

topics: (1) Complaint files and 

procedures for receiving, reviewing and 

evaluating complaints; (2) complaint 

investigation records identifying the 

device, complainant, and relationship of 

the device to the incident; (3) complaint 

records that are reasonably accessible to 

the manufacturing site or at prescribed 

sites; (4) procedures for performing and 

verifying that device servicing 

requirements are met and that service 

reports involving complaints are 

processed as complaints; and (5) service 

reports that record the device, service 

activity, and test and inspection data. 

Section 820.250 requires the 

establishment and maintenance of 

procedures to identify valid statistical 

techniques necessary to verify process 

and product acceptability; and sampling 

plans, when used, which are written 

and based on valid statistical rationale; 

and procedures for ensuring adequate 

sampling methods. The CGMP/QS 

regulation amends and revises the 

CGMP requirements for medical devices 

set out under part 820. The regulation 

adds design and purchasing controls; 

modifies previous critical device 

requirements; revises previous 

validation and other requirements; and 

harmonizes device CGMP requirements 

with QS specifications in the 

international standard ‘‘ISO 9001: 

Quality Systems Model for Quality 

Assurance in Design/Development, 

Production, Installation, and Servicing.’’ 

The rule does not apply to 

manufacturers of components or parts of 

finished devices, nor to manufacturers 

of human blood and blood components 

subject to 21 CFR part 606. With respect 

to devices classified in class I, design 

control requirements apply only to class 

I devices listed in § 820.30(a)(2) of the 

regulation. The rule imposes burden 

upon: (1) Finished device manufacturer 

firms, which are subject to all 

recordkeeping requirements; (2) 

finished device contract manufacturers, 

specification developers; and (3) 

repacker, relabelers, and contract 

sterilizer firms, which are subject only 

to requirements applicable to their 

activities. In addition, remanufacturers 

of hospital single-use devices (SUDs) 

will now be considered to have the 

same requirements as manufacturers in 

regard to this regulation. The 

establishment, maintenance and/or 

documentation of procedures, records, 

and data required by this regulation will 

assist FDA in determining whether 

firms are in compliance with CGMP 

requirements, which are intended to 

ensure that devices meet their design, 

production, labeling, installation, and 

servicing specifications and, thus are 

safe, effective and suitable for their 

intended purpose. In particular, 

compliance with CGMP design control 

requirements should decrease the 

number of design-related device failures 

that have resulted in deaths and serious 

injuries. 

The CGMP/QS regulation applies to 

approximately 8,924 respondents. These 

recordkeepers consist of 8,945 original 

respondents and an estimated 18 

hospitals that remanufacture or reuse 

SUDs. They include manufacturers, 

subject to all requirements and contract 

manufacturers, specification developers, 

repackers, relabelers, and contract 

sterilizers, subject only to requirements 

applicable to their activities. Hospital 

remanufacturers of SUDs are now 

defined to be manufacturers under 

guidelines issued by FDA’s Center for 

Devices and Radiological Health 

(CDRH), Office of Surveillance and 

Biometrics. Respondents to this 

collection have no reporting activities, 

but must make required records 

available for review or copying during 

FDA inspection. The regulation contains 

additional recordkeeping requirements 

in such areas as design control, 

purchasing, installation, and 

information relating to there 

manufacture of SUDs. The estimates for 

this burden are derived from those 

incremental tasks that were determined 

when the new CGMP/QS regulation 

became final as well as those carryover 

requirements. The carryover 

requirements are based on decisions 

made by the agency on July 16, 1992, 

under OMB Control Number 0910–0073, 

which still provides valid base line data. 

Explanation of Recordkeeping Burden 

Estimate 

FDA estimates respondents will have 

a total annual recordkeeping burden of 

approximately 3,105,552 hours. This 

figure also consists of approximately 

143,052 hours spent on a startup basis 

by 734 new firms. 

Burden (labor) hour and cost 

estimates were originally developed 

under FDA contract by Eastern Research 

Group, Inc. (ERG), in 1996 when the 

CGMP/QS regulation became final. 

Additional factors considered in 

deriving estimates included the 

following: 

• Establishment type: Query has been 

made of CDRH’s registration/listing 

databank and the current count was 

7,748 domestic firms subject to CGMPs. 

It was also calculated that each year, the 

number of new domestic firms subject 

to CGMPs is 734. The average amount 

of firms therefore subject to CGMPs over 

the 3 years is therefore 8,924 and this 

figure has been used to calculate the 

total burden. Because the total number 

of registered firms is not static, the 

number of respondents will fluctuate 

from year to year resulting in slight 

changes to the overall burden. 

• During the last report it was 

estimated that this number was 8,963. 

When the last set of numbers was 

calculated, FDA was still using a paper 

based system to register and list firms. 

On October 1, 2007, FDA switched to an 

electronic system for registration and 

listing. Also at that time the Food and 

Drug Administration Amendments Act 

of 2007 instituted an establishment 

registration fee for some types of 

facilities. FDA believes that during the 

fiscal year 2008 annual registration 

cycle, establishments that had 

previously registered but were not 

required to do so, removed themselves 

from inventory of active establishments. 

FDA believes that the current figures 

reported by the electronic system more 

accurately reflect the inventory of 

registered establishments. 

• Potentially affected establishments: 

Except for manufacturers, not every type 

of firm is subject to every CGMP/QS 

requirement. For example, all are 

subject to Quality Policy (§ 820.20(a)), 

Document Control (§ 820.40), and other 

requirements, whereas only 

manufacturers and specification 

developers are subject to subpart C, 

Design Controls. The type of firm 

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Federal Register / Vol. 75, No. 200 / Monday, October 18, 2010 / Notices 63837 

subject to each requirement was 

identified by the ERG. 

• FDA estimated the burden hours 

(and costs) for the previous CGMP 

regulation in 1992. That estimate was 

submitted to OMB on May 4, 1992, 

under OMB Paperwork Reduction Act 

Control Number 0910–0073. It was 

approved by OMB on July 16, 1992, and 

expired on June 30, 1995. The 

methodology used is different than that 

used by ERG in estimating incremental 

tasks when the new CGMP/QS became 

final rule. Nevertheless, the agency 

believes its 1992 estimate adequately 

represents labor hours (and costs) 

needed to comply with previous CGMP 

requirements carried over into the new 

CGMP/QS regulation. The 1992 estimate 

used 9,289 respondents (rather than 

8,924 respondents), which compensates 

for differences in methodology. 

In the Federal Register of June 24, 

2010 (75 FR 36092), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received two 

comments, however only one was 

regarding the information collection. 

One part of the comment questioned a 

technical reference found within the 60- 

day notice, stating not that the reference 

was incorrect, but that it may be 

somewhat misleading since the 

reference is updated on a regular basis 

and this was not communicated in the 

notice. While the commenter is correct 

that ISO 9001 is on version 2008 and 

ISO/DIS 13485 is on version 2003, the 

standard ISO 9001 and ISO/DIS 13485 

are referenced because they are the 

standard regardless of version. 

Another part of the comment 

maintains that the term ‘‘collect’’ is 

misleading as it pertains to 

recordkeeping requirements because 

relevant documents are only submitted 

if requested; however, the comment 

agrees that the information collection is 

necessary. Under the PRA regulations, 

records retention is considered 

‘‘information collection,’’ as defined by 

the PRA 5 CFR 1320.3 

A third part of the comment stated 

that it was not clear to whom the 

regulations applied based on the 

statement, ‘‘[e]xcept for manufacturers, 

not every type of firm is subject to every 

CGMP/QS requirement.’’ FDA believes 

the scope of the regulations found at 

part 820.1 makes it clear to whom the 

requirements are applicable. 

The commenter questioned the 

validity and availability of a study that 

was conducted by the ERG in 1996, 

claiming that without benefit of the 

study itself, comments regarding burden 

estimates were too difficult to make. As 

a basis for its burden estimates, the 

agency relied in part on certain pieces 

of information found in the 1996 study 

and recommends that FDA make this 

document part of the docket. The study 

was submitted to OMB as part of the 

original PRA approval and is part of the 

Federal docket. 

The commenter states that FDA 

assumes that the burden for each firm is 

the same, i.e., each of the 8,924 firms 

has exactly the same burden. The 

flexibility of the system suggests that the 

‘‘one size fits all’’ approach in the 

Federal Register is not appropriate. The 

PRA burden placed on the 8,924 firms 

is an average burden on respondents. 

The commenter believes that the 

estimates the agency provides are too 

low, but does not offer an alternative 

methodology for estimating that the 

agency may review. The comment goes 

on to suggest, however, that a new 

analysis similar to the 1996 study be 

conducted and serve as the basis for 

future burden estimates because our 

estimates have not changed in several 

years. While FDA agrees that additional 

analysis is always helpful in 

determining burden, the agency does 

perform ongoing reviews of the burden 

associated with PRA burden as required 

under the PRA for purposes of 

evaluating burden associated with its 

information collection requests, and has 

done so for purposes of renewing these 

CGMP/QS regulations. 

Finally, the commenter suggests that 

the agency’s regulation regarding 

electronic signatures found at part 11 

(21 CFR part 11) is overly cumbersome 

to many firms. Part 11 is a separate 

regulation from part 820, and it is only 

mentioned for reference purposes in the 

preamble. The record keeping for part 

11 is not within the scope of this 

paperwork analysis. 

Also, CDRH is proactive in ensuring 

that the medical device industry and 

other affected individuals are made 

aware of on-going issues relating to the 

CGMP/QS regulations. FDA’s Medical 

Device GMP/QS experts have 

participated in numerous conferences 

and seminars relating to the CGMP/QS 

regulatory requirements. During these 

sessions, our GMP/QS experts share 

information through speeches and panel 

discussions that provide a forum for 

open discussion. During these 

discussions guidance and direction is 

often given to the audience to help them 

understand their regulatory 

responsibilities under the GMP/QS 

regulation. In addition, issues are 

sometimes identified by the audience 

that provides the agency areas that we 

may need to clarify to affected 

individuals. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

CFR section Number of 

recordkeepers 

Annual 

frequency per 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

820.20(a) .......................................................... 8,924 1 8,924 7 62,468 

820.20(b) .......................................................... 8,924 1 8,924 4 35,696 

820.20(c) .......................................................... 8,924 1 8,924 6 53,544 

820.20(d) .......................................................... 8,924 1 8,924 10 89,240 

820.20(e) .......................................................... 8,924 1 8,924 10 89,240 

820.22 .............................................................. 8,924 1 8,924 33 294,492 

820.25(b) .......................................................... 8,924 1 8,924 13 116,012 

820.30(a)(1) ..................................................... 8,924 1 8,924 2 17,848 

820.30(b) .......................................................... 8,924 1 8,924 6 53,544 

820.30(c) .......................................................... 8,924 1 8,924 2 17,848 

820.30(d) .......................................................... 8,924 1 8,924 2 17,848 

820.30(e) .......................................................... 8,924 1 8,924 23 205,252 

820.30(f) ........................................................... 8,924 1 8,924 37 330,188 

820.30(g) .......................................................... 8,924 1 8,924 37 330,188 

820.30(h) .......................................................... 8,924 1 8,924 3 26,772 

820.30(i) ........................................................... 8,924 1 8,924 17 151,708 

820.30(j) ........................................................... 8,924 1 8,924 3 26,772 

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63838 Federal Register / Vol. 75, No. 200 / Monday, October 18, 2010 / Notices 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued 

CFR section Number of 

recordkeepers 

Annual 

frequency per 

recordkeeping 

Total annual 

records 

Hours per 

record Total hours 

820.40 .............................................................. 8,924 1 8,924 9 80,316 

820.40(a) and (b) ............................................. 8,924 1 8,924 2 17,848 

820.50(a)(1) through (a)(3) .............................. 8,924 1 8,924 22 196,328 

820.50(b) .......................................................... 8,924 1 8,924 6 53,544 

820.6 ................................................................ 8,924 1 8,924 1 8,924 

820.65 .............................................................. 8,924 1 8,924 1 8,924 

820.70(a)(1) through (a)(5) .............................. 8,924 1 8,924 2 17,848 

820.70(b) and (c) ............................................. 8,924 1 8,924 2 17,848 

820.70(d) .......................................................... 8,924 1 8,924 3 26,772 

820.70(e) .......................................................... 8,924 1 8,924 2 17,848 

820.70(g)(1) through (g)(3) .............................. 8,924 1 8,924 1 8,924 

820.70(h) .......................................................... 8,924 1 8,924 2 17,848 

820.70(i) ........................................................... 8,924 1 8,924 8 71,392 

820.72(a) .......................................................... 8,924 1 8,924 5 44,620 

820.72(b)(1) and (b)(2) .................................... 8,924 1 8,924 1 8,924 

820.75(a) .......................................................... 8,924 1 8,924 3 26,772 

820.75(b) .......................................................... 8,924 1 8,924 1 8,924 

820.75(c) .......................................................... 8,924 1 8,924 1 8,924 

820.80(a) through (e) ....................................... 8,924 1 8,924 5 44,620 

820.86 .............................................................. 8,924 1 8,924 1 8,924 

820.90(a) .......................................................... 8,924 1 8,924 5 44,620 

820.90(b)(1) and (b)(2) .................................... 8,924 1 8,924 5 44,620 

820.100(a)(1) through (a)(7) ............................ 8,924 1 8,924 12 107,088 

820.100(b) ........................................................ 8,924 1 8,924 1 8,924 

820.120(b) ........................................................ 8,924 1 8,924 1 8,924 

820.120(d) ........................................................ 8,924 1 8,924 1 8,924 

820.130 ............................................................ 8,924 1 8,924 1 8,924 

820.140 ............................................................ 8,924 1 8,924 6 53,544 

820.150(a) and (b) ........................................... 8,924 1 8,924 6 53,544 

820.160(a) and (b) ........................................... 8,924 1 8,924 1 8,924 

820.170(a) and (b) ........................................... 8,924 1 8,924 2 17,848 

820.180(b) and (c) ........................................... 8,924 1 8,924 2 17,848 

820.181(a) through (e) ..................................... 8,924 1 8,924 1 8,924 

820.184(a) through (f) ...................................... 8,924 1 8,924 1 8,924 

820.186 ............................................................ 8,924 1 8,924 1 8,924 

820.198(a) through (c) ..................................... 8,924 1 8,924 5 44,620 

820.200(a) and (d) ........................................... 8,924 1 8,924 3 26,772 

820.25 .............................................................. 8,924 1 8,924 1 8,924 

Totals ........................................................ ............................ ............................ ............................ ............................ 3,105,552 

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

Dated: October 12, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–26102 Filed 10–15–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0344] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Testing 

Communications on Medical Devices 

and Radiation-Emitting Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by November 

17, 2010. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–NEW and 

the title ‘‘Testing Communications on 

Medical Devices and Radiation-Emitting 

Products.’’ Also include the FDA 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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Testing Communications on Medical 

Devices and Radiation-Emitting 

Products—(OMB Control Number 0910– 

NEW) 

FDA is authorized by section 

1003(d)(2)(D) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 

393(d)(2)(D)) to conduct educational 

and public information programs 

mstockstill on DSKH9S0YB1PROD with NOTICES