[Federal Register Volume 69, Number 113 (Monday, June 14, 2004)]
[Notices]
[Pages 33035-33040]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-13212]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0034]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Devices; 
Current Good Manufacturing Practice Quality System Regulation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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

[[Page 33036]]

(OMB) for review and clearance under the Paperwork Reduction Act of 
1995.

DATES:  Fax written comments on the collection of information by July 
14, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, 
Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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 (CGMP) Quality 
System (QS) Regulations--21 CFR Part 820 (OMB Control Number 0910-
0073)--Extension

    Under section 520(f) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 360j(f)), the Secretary of the Department of 
Health and Human Services (the Secretary) has the authority to 
prescribe regulations requiring that the methods used in, and the 
facilities and controls used for, the manufacture, pre-production 
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 
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/QS regulation implementing the authority provided by this 
statutory provision is found at 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 the 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 requirements for product acceptance activities quality data 
evaluations and corrections of nonconforming product/quality problems. 
Requirements are compatible with specifications in international 
quality standards, ISO (International Organization for Standardization) 
9001 entitled ``Quality Systems Model for Quality Assurance in Design/
Development, Production, Installation, and Servicing.'' CGMP/QS 
information collections will assist FDA inspections of manufacturer 
compliance with quality system 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 these topics: The 
quality policy, the organizational structure, the quality plan, and the 
quality system procedures of the organization. Section 820.22 requires 
the conduct and documentation of quality system 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 the following 
respective order, the establishment, maintenance, and/or documentation 
of these 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 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), and (h) and (i) requires the establishment, 
maintenance, and/or documentation of these 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) and (b)(1) and (b)(2) and 820.75(a) through (c) 
require, respectively, the establishment, maintenance, and/or 
documentation of these 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 these topics: 
(1) Procedures for incoming acceptance by inspection, test or other 
verification; (2) procedures for ensuring that in-process

[[Page 33037]]

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), (b)(2), and 820.100 require, 
respectively, the establishment, maintenance and/or documentation of 
these 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 these 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 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: (1) That are 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) that are contained or referenced in a 
DMR consisting of device, process, quality assurance, packaging and 
labeling, and installation, maintenance, and servicing specifications 
and procedures; (3) that are contained in DHRs, demonstrate the 
manufacture of each unit, lot or batch of product in conformance with 
DMR and regulatory requirements, and include manufacturing and 
distribution dates and quantities, acceptance documents, labels and 
labeling, and control numbers; and (4) that are 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) and (d), 
respectively, require the establishment, maintenance and/or 
documentation of these 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, that 
are written and based on a 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 at part 820. It adds design and purchasing 
controls; modifies previous critical device requirements; revises 
previous validation and other requirements; and harmonizes device CGMP 
requirements with quality system specifications in the international 
standard, ISO 9001:1994 entitled ``Quality Systems--Model for Quality 
Assurance in Design, Development Production, Installation and 
Servicing.'' The regulation applies neither 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 Sec.  820.30(a)(2).
    The regulation imposes burdens upon finished device manufacturer 
firms, which are subject to all recordkeeping requirements, and also 
upon finished device contract manufacturer, specification developer, 
repacker and relabeler, and contract sterilizer firms, which are 
subject only to requirements applicable to their activities. Due to 
modifications to the guidance given for remanufacturers of hospital 
single-use devices, reusers of hospital single-use devices 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.
    If FDA did not impose these recordkeeping requirements, it 
anticipates that design-related device failures would continue to occur 
in the same numbers as before and continue to result in a significant 
number of device recalls and preventable deaths and serious injuries. 
Moreover, manufacturers would be unable to take advantage of 
substantial savings attributable to reduced recall costs, improved 
manufacturing efficiency, and improved access to international markets 
through compliance with CGMP requirements that are harmonized with 
international quality system standards.
    The CGMP/QS regulation applies to some 8,254 respondents. These 
recordkeepers consist of 8,188 original respondents and an estimated 66 
hospitals which remanufacture or reuse single use medical devices. They 
include manufacturers, subject to all requirements and contract

[[Page 33038]]

manufacturers, specification developers, repackers/relabelers and 
contract sterilizers, subject only to requirements applicable to their 
activities. Hospital remanufacturers of single use medical devices 
(SUDs) are now defined to be manufacturers under guidelines issued by 
FDA's Center for Devices and Radiological Health's (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 the remanufacture 
of single use medical devices. The estimates for burden are derived 
from those incremental tasks that were determined when the new CGMP/QS 
regulation became final as well as those carry-over requirements. The 
carry-over requirements are based on decisions made by the agency on 
July 16, 1992, under OMB control number 0910-0073. This still provides 
valid baseline data.
    FDA estimates respondents will have a total annual recordkeeping 
burden of approximately 2,833,020 hours. This figure also consists of 
approximately 143,052 hours spent on a startup basis by 650 new firms. 
FDA estimates information collection burdens imposed as follows:

                                                    Table 1.--Estimated Annual Recordkeeping Burden1
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                                                                                                                                        Total Operating
              CFR Section                   Number of       Annual Frequency     Total Annual        Hours per         Total Hours      and Maintenance
                                          Recordkeepers     of Recordkeeping        Hours           Recordkeeper                              Cost
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820.20(a)                                        8,254                  1              8,254                  6.58          54,311          ---------
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820.20(b)                                        8,254                  1              8,254                  4.43          36,565          ---------
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820.20(c)                                        8,254                  1              8,254                  6.17          50,927          ---------
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820.20(d)                                        8,254                  1              8,254                  9.89          81,632          ---------
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820.20(e)                                        8,254                  1              8,254                  9.89          81,632          ---------
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820.22                                           8,254                  1              8,254                 32.72         270,071          ---------
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820.25(b)                                        8,254                  1              8,254                 12.68         104,661          ---------
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820.30(a)(1)                                     8,254                  1              8,254                  1.75          14,445          ---------
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820.30(b)                                        8,254                  1              8,254                  5.95          49,111          ---------
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820.30(c)                                        8,254                  1              8,254                  1.75          14,445          ---------
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820.30(d)                                        8,254                  1              8,254                  1.75          14,445          ---------
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820.30(e)                                        8,254                  1              8,254                 23.39         193,061          ---------
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820.30(f)                                        8,254                  1              8,254                 37.42         308,865          ---------
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820.30(g)                                        8,254                  1              8,254                 37.42         308,865          ---------
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820.30(h)                                        8,254                  1              8,254                  3.34          27,568          ---------
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820.30(i)                                        8,254                  1              8,254                 17.26         142,464          ---------
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820.30(j)                                        8,254                  1              8,254                  2.64          21,791          ---------
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820.4                                            8,254                  1              8,254                  8.91          73,543          ---------
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820.40(a)-(b)                                    8,254                  1              8,254                  2.04          16,838          ---------
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820.50(a)(1)-(a)(3)                              8,254                  1              8,254                 21.9          180,763         $1,181,925
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820.50(b)                                        8,254                  1              8,254                  6.02          49,689          ---------
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820.60                                           8,254                  1              8,254                  0.32           2,641          ---------
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820.65                                           8,254                  1              8,254                  0.67           5,530          ---------
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820.70(a)(1)-(a)(5)                              8,254                  1              8,254                  1.85          15,270          ---------
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820.70(b)-(c)                                    8,254                  1              8,254                  1.85          15,270          ---------
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820.70(d)                                        8,254                  1              8,254                  2.87          23,689          ---------
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820.70(e)                                        8,254                  1              8,254                  1.85          15,270          ---------
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[[Page 33039]]

 
820.70(g)(1)-(g)(3)                              8,254                  1              8,254                  1.43          11,803          ---------
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820.70(h)                                        8,254                  1              8,254                  1.85          15,270          ---------
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820.72(a)                                        8,254                  1              8,254                  4.92          40,610          ---------
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820.70(i)                                        8,254                  1              8,254                  7.5           61,905          ---------
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820.72(b)(1) to (b)(2)                           8,254                  1              8,254                  1.43          11,803          ---------
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820.75(a)                                        8,254                  1              8,254                  2.69          22,203          ---------
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820.75(b)                                        8,254                  1              8,254                  1.02           8,419          ---------
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820.75(c)                                        8,254                  1              8,254                  1.11           9,162          ---------
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820.80(a)-(e)                                    8,254                  1              8,254                  4.8           39,619          ---------
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820.86                                           8,254                  1              8,254                  0.79           6,521          ---------
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820.90(a)                                        8,254                  1              8,254                  4.95          40,857          ---------
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820.90(b)(1)-(b)(2)                              8,254                  1              8,254                  4.95          40,857          ---------
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820.100(a)(1)-(a)(7)                             8,254                  1              8,254                 12.48         103,010          ---------
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820.100(b)                                       8,254                  1              8,254                  1.28          10,565          ---------
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820.120                                          8,254                  1              8,254                  0.45           3,714          ---------
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820.120(b)                                       8,254                  1              8,254                  0.45           3,714          ---------
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820.120(d)                                       8,254                  1              8,254                  0.45           3,714          ---------
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820.130                                          8,254                  1              8,254                  0.45           3,714          ---------
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820.140                                          8,254                  1              8,254                  6.34          52,330          ---------
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820.150(a)-(b)                                   8,254                  1              8,254                  5.67          46,800          ---------
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820.160(a)-(b)                                   8,254                  1              8,254                  0.67           5,530          ---------
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820.170(a)-(b)                                   8,254                  1              8,254                  1.5           12,381          ---------
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820.180(b)-(c)                                   8,254                  1              8,254                  1.5           12,381          ---------
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820.181((a)-(e)                                  8,254                  1              8,254                  1.21           9,987          ---------
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820.184(a)-(f)                                   8,254                  1              8,254                  1.41          11,638          ---------
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820.186                                          8,254                  1              8,254                  0.4            3,302          ---------
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820.198(a)-(c)                                   8,254                  1              8,254                  4.94          40,775          ---------
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820.200(a) and (d)                               8,254                  1              8,254                  2.61          21,543          ---------
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820.250                                          8,254                  1              8,254                  0.67           5,530          ---------
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Totals                                  .................  .................  .................  .................       2,283,020         $1,181,925
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    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. These figures are still accurate. 
Additional factors considered in deriving estimates included:

[[Page 33040]]

     Establishment type: Query has been made of CDRH's 
registration/listing databank and has counted 8,188 domestic firms 
subject to CGMPs. In addition, hospitals which reuse or remanufacture 
devices are now considered manufacturers under new FDA guidance. During 
the last report, it was estimated that out of the 6,000 hospitals in 
the United States, one third of them (or 2,000 hospitals) will reuse or 
remanufacture single use medical devices. After investigations of many 
hospitals and the changes in enforcements of FDA's requirements for 
hospitals, the number of reuse or remanufactures of single-use medical 
devices have decreased from the estimated 2,000 to an estimated 66 
hospitals. Thus, the number of manufacturers will increase from 7,229 
to 8,188, but the total number of firms subject to CGMPs will decrease 
from 9,229 to 8,254.
     Potentially affected establishments: Except for 
manufacturers, not every type of firm is subject to every CGMP/QS 
requirement. For example, all are subject to FDA's quality policy 
regulations (Sec.  820.20(a)), document control regulations (Sec.  
820.40), and other requirements, whereas only manufacturers and 
specification developers are subject to FDA's design controls 
regulations (Sec.  820.30). The type of firm subject to each 
requirement was identified by 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. 
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. 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 8,254 respondents), which compensates for 
differences in methodology.
    FDA estimates that some 650 ``new'' establishments (marketing 
devices for the first time) will expend some 143,052 ``development'' 
hours on a one-time startup basis to develop records and procedures for 
the CGMP/QS regulation.
    FDA estimates that annual labor hours are apportioned as follows: 
40 percent goes to requirements dealing with manufacturing 
specifications, process controls and the DHR; 20 percent goes to 
requirements dealing with components and acceptance activities; 25 
percent goes to requirements dealing with equipment, records (the DMR 
and QSR), complaint investigations, labeling/packaging and 
reprocessing/investigating product nonconformance; and 15 percent goes 
to quality audit, traceability, handling, distribution, statistical, 
and other requirements.

    Dated: June 4, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-13212 Filed 6-10-04; 8:45 am]
BILLING CODE 4160-01-S