CURRENT GOOD MANUFACTURING PRACTICES

FOR FINISHED PHARMACEUTICALS

OMB CONTROL NO. 0910-0139

Docket No. 02N-0007

Expiration Date: August 31, 2005

A **[Justification]{.underline}**

1\. **[Circumstances of Information Collection]{.underline}**

Under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 351(a)(2)(B)), a drug is adulterated if the methods
used in, or the facilities or controls used for, its manufacture,
processing, packing, or holding do not conform to or are not operated or
administered in conformity with CGMPs to ensure that such drug meets the
requirements of the act as to safety and has the identity and strength,
and meets the quality and purity characteristics, which it purports or
is represented to possess.

FDA has the authority under section 701(a) of the act (21 U.S.C. 371(a))
to issue regulations for the efficient enforcement of the act regarding
CGMP procedures for manufacturing, processing, and holding drugs and
drug products. The CGMP regulations help ensure that drug products meet
the statutory requirements for safety and have their purported or
represented identity, strength, quality, and purity characteristics. The
information collection requirements in the CGMP regulations provide FDA
with the necessary information to perform its duty to protect public
health and safety. CGMP requirements establish accountability in the
manufacturing and processing of drug products, provide for meaningful
FDA inspections, and enable manufacturers to improve the quality of drug
products over time. The CGMP recordkeeping requirements also serve
preventive and remedial purposes and provide crucial information if it
is necessary to recall a drug product.

The general requirements for recordkeeping under part 211 (21 CFR part
211) are set forth in 211.180. Any production, control, or distribution
record associated with a batch and required to be maintained in
compliance with part 211 must be retained for at least 1 year after the
expiration date of the batch and, for certain OTC drugs, 3 years after
distribution of the batch ( 211.180(a)). Records for all components,
drug product containers, closures, and labeling are required to be
maintained for at least 1 year after the expiration date and 3 years for
certain OTC products ( 211.180(b)).

All part 211 records must be readily available for authorized
inspections during the retention period ( 211.180(c)), and such records
may be retained either as original records or as true copies (
211.180(d)). In addition, 21 CFR 11.2(a) provides that \"for records
required to be maintained but not submitted to the agency, persons may
use electronic records in lieu of paper records or electronic signatures
in lieu of traditional signatures, in whole or in part, provided that
the requirements of this part are met.\" To the extent this electronic
option is used, the burden of maintaining paper records should be
substantially reduced as should any review of such records.

In order to facilitate improvements and corrective actions, records must
be maintained so that data can be used for evaluating, at least
annually, the quality standards of each drug product to determine the
need for changes in drug product specifications or manufacturing or
control procedures. ( 211.180(e)). Written procedures for these
evaluations are to be established and include provisions for a review of
a representative number of batches and, where applicable, records
associated with the batch, and provisions for a review of complaints,
recalls, returned or salvaged drug products, and investigations
conducted under 211.192 for each drug product.

The specific recordkeeping requirements provided in the table below are
as follows:

21 CFR 211.34 - Consultants advising on the manufacture, processing,
packing, or holding of drug products must have sufficient education,
training, and experience to advise on the subject for which they are
retained. Records must be maintained stating the name, address, and
qualifications of any consultants and the type of service they provide.

21 CFR 211.67(c) - Records must be kept of maintenance, cleaning,
sanitizing, and inspection as specified in 211.180 and 211.182.

21 CFR 211.68 - Appropriate controls must be exercised over computer or
related systems to assure that changes in master production and control
records or other records are instituted only by authorized personnel.

21 CFR 211.68(a) - Records must be maintained of calibration checks,
inspections, and computer or related system programs for automatic,
mechanical, and electronic equipment.

21 CFR 211.68(b) - All appropriate controls must be exercised over all
computers or related systems and control data systems to assure that
changes in master production and controls records or other records are
instituted only by authorized persons.

21 CFR 211.72 - Filters for liquid filtration used in the manufacture,
processing, or packing of injectable drug products intended for human
use must not release fibers into such products.

21 CFR 211.80(d) - Each container or grouping of containers for
components or drug product containers or closures must be identified
with a distinctive code for each lot in each shipment received. This
code must be used in recording the disposition of each lot. Each lot
must be appropriately identified as to its status.

21 CFR 211.100(b) - Written production and process control procedures
must be followed in the execution of the various production and process
control functions and must be documented at the time of performance. Any
deviation from the written procedures must be recorded and justified.

21 CFR 211.105(b) - Major equipment must be identified by a distinctive
identification number or code that must be recorded in the batch
production record to show the specific equipment used in the manufacture
of each batch of a drug product. In cases where only one of a particular
type of equipment exists in a manufacturing facility, the name of the
equipment may be used in lieu of a distinctive identification number or
code.

21 CFR 211.122(c) - Records must be maintained for each shipment
received of each different labeling and packaging material indicating
receipt, examination, or testing.

21 CFR 211.130(e) - Inspection of packaging and labeling facilities must
be made immediately before use to assure that all drug products have
been removed from previous operations. Inspection must also be made to
assure that packaging and labeling materials not suitable for subsequent
operations have been removed. Results of inspection must be documented
in the batch production records.

21 CFR 211.132(c) - Certain retail packages of OTC drug products must
bear a statement that is prominently placed so consumers are alerted to
the specific tamper-evident feature of the package. The labeling
statement is required to be so placed that it will be unaffected if the
tamper-resistant feature of the package is breached or missing. If the
tamper-evident feature chosen is one that uses an identifying
characteristic, that characteristic is required to be referred to in the
labeling statement.

21 CFR 211.132(d) - A request for an exemption from packaging and
labeling requirements by a manufacturer or packer is required to be
submitted in the form of a citizen petition under 21 CFR 10.30*.*

21 CFR 211.137 - Requirements regarding product expiration dating and
compliance with 201.17.

21 CFR 211.160(a) - The establishment of any specifications, standards,
sampling plans, test procedures, or other laboratory control mechanisms,
including any change in such specifications, standards, sampling plans,
test procedures, or other laboratory control mechanism, must be drafted
by the appropriate organizational unit and reviewed and approved by the
quality control unit. These requirements must be followed and documented
at the time of performance. Any deviation from the written
specifications, standards, sampling plans, test procedures, or other
laboratory control mechanisms must be recorded and justified.

21 CFR 211.165(e) - The accuracy, sensitivity, specificity, and
reproducibility of test methods employed by a firm must be established
and documented. Such validation and documentation may be accomplished in
accordance with 211.194(a)(2).

21 CFR 211.166(c) - Specifies homeopathic drug product requirements.

21 CFR 211.173 - Animals used in testing components, in-process
materials, or drug products for compliance with established
specifications must be maintained and controlled in a manner that
assures their suitability for their intended use. They must be
identified, and adequate records must be maintained showing the history
of their use.

21 CFR 211.180(e) - Written records required by this part must be
maintained so that data can be used for evaluating, at least annually,
the quality standards of each drug product to determine the need for
changes in drug product specifications or manufacturing or control
procedures. Written procedures must be established and followed for such
evaluations and must include provisions for a representative number of
batches, whether approved or unapproved or rejected, and a review of
complaints, recalls, returned or salvaged drug products, and
investigations conducted under 211.192 for each drug product.

21 CFR 211.180(f) - Procedures must be established to assure that the
responsible officials of the firm, if they are not personally involved
in or immediately aware of such actions, are notified in writing of any
investigations, conducted under 211.198, 211.204, or 211.208, any
recalls, reports of inspectional observations issued, or any regulatory
actions relating to good manufacturing practices brought by FDA.

21 CFR 211.182 - Specifically explains equipment cleaning and the use
log.

21 CFR 211.184 - Specifies component, drug product container, closure,
and labeling records.

21 CFR 186 - Specifies master production and control records.

21 CFR 211.188 - Specifies batch production and control records.

21 CFR 211.192 - Specifies the information that must be maintained on
the investigation of discrepancies found in the review of all drug
product production and control records by the quality control staff.

21 CFR 211.194 - Explanation and description of laboratory records that
must be retained.

21 CFR 211.196 - Specifies the information that must be included in
records on the distribution of the drug.

21 CFR 211.198 - Specifies and describes the handling of all complaint
files received by the applicant.

21 CFR 211.204 - Specifies that records be maintained of returned and
salvaged drug product and describes the procedures involved.

Written procedures, referred to here as standard operating procedures
(SOPs), are required for many part 211 records. The current SOP
requirements were initially provided in a final rule published in the
*Federal Register* of September 29, 1978 (43 FR 45014), and are now an
integral and familiar part of the drug manufacturing process. The major
information collection impact of SOPs results from their creation.
Thereafter, SOPs need to be periodically updated. A combined estimate is
provided in the table below for routine maintenance of SOPs. The 25 SOP
provisions under part 211 in the combined maintenance estimate include:

\(1\) 211.22(d) - Responsibilities and procedures of the quality control
unit;

\(2\) 211.56(b) - Sanitation procedures;

\(3\) 211.56(c) - Use of suitable rodenticides, insecticides,
fungicides, fumigating agents, and cleaning and sanitizing agents;

\(4\) 211.67(b) - Cleaning and maintenance of equipment;

\(5\) 211.68(a) - Proper performance of automatic, mechanical, and
electronic equipment;

\(6\) 211.80(a) - Receipt, identification, storage, handling, sampling,
testing, approval or rejection of components and drug product containers
or closures;

\(7\) 211.94(d) - Standards or specifications, methods of testing, and
methods of cleaning, sterilizing, and processing to remove pyrogenic
properties for drug product containers and closures;

\(8\) 211.100(a) - Production and process control;

\(9\) 211.110(a) - Sampling and testing of in-process materials and drug
products;

\(10\) 211.113(a) - Prevention of objectionable microorganisms in drug
products not required to be sterile;

\(11\) 211.113(b) - Prevention of microbiological contamination of drug
products purporting to be sterile, including validation of any
sterilization process;

\(12\) 211.115(a) -System for reprocessing batches that do not conform
to standards or specifications, to insure that reprocessed batches
conform with all established standards, specifications, and
characteristics;

\(13\) 211.122(a) - Receipt, identification, storage, handling,
sampling, examination and/or testing of labeling and packaging
materials;

\(14\) 211.125(f) - Control procedures for the issuance of labeling;

\(15\) 211.130 - Packaging and label operations, prevention of mixup and
cross contamination, identification and handling of filed drug product
containers that are set aside and held in unlabeled condition,
identification of the drug product with a lot or control number that
permits determination of the history of the manufacture and control of
the batch;

\(16\) 211.142 - Warehousing;

\(17\) 211.150 - Distribution of drug products;

\(18\) 211.160 - Laboratory controls;

\(19\) 211.165(c) - Testing and release for distribution;

\(20\) 211.166(a) - Stability testing;

\(21\) 211.167 - Special testing requirements;

\(22\) 211.180(f) - Notification of responsible officials of
investigations, recalls, reports of inspectional observations, and any
regulatory actions relating to good manufacturing practice;

\(23\) 211.198(a) - Written and oral complaint procedures, including
quality control unit review of any complaint involving specifications
failures, and serious and unexpected adverse drug experiences;

\(24\) 211.204 - Holding, testing, and reprocessing of returned drug
products; and

\(25\) 211.208 - Drug product salvaging.

Although most of the CGMP provisions covered in this document were
created many years ago, there will be some existing firms expanding into
new manufacturing areas and start-up firms that will need to create
SOPs. As provided in the table below, FDA is assuming that approximately
100 firms will have to create up to 25 SOPs for a total of 2,500
records, and the agency estimates that it will take 20 hours per
recordkeeper to create 25 new SOPs for a total of 50,000 hours.

**2. [Purpose and Use of Information]{.underline}**

The purpose of these recordkeeping requirements is to enable a
manufacturer and FDA to identify and investigate any problems that may
arise with a drug product. Failure to have these records available for
an investigation could prevent resolution of undesirable conditions that
can seriously compromise public health. FDA is authorized to inspect
these records under the mandatory inspection authority of section 704 of
the act (21 U.S.C. 374) (and its enforcement section under section
301(f) of the act 21 U.S.C. 331(f)).

**3. [Use of Improved Information Technology]{.underline}**

Records required by CGMP regulations are designed and maintained by drug
manufacturers. Because the CGMP regulations provide great latitude on
how these requirements are to be achieved, manufacturers are allowed to
establish their own methods of recordkeeping. FDA accepts any
recordkeeping method which meets the objectives of the 21 CFR Part 211.
For example, drug manufacturing establishments may use automatic,
mechanical, or electronic equipment or other types of equipment,
including computers, or related systems that will perform a function
satisfactorily, to comply with these recordkeeping requirements.
Computer tapes, microfiche, or microfilm or copies may be used in lieu
of hard copy records to collect, retrieve, and store information. In
addition, in accordance with the requirements of 21 CFR Part 11, FDA
considers electronic records to be trustworthy, reliable, and generally
equivalent to paper records.

**4.** **[Efforts to Identify Duplication]{.underline}**

As part of the retrospective review of the CGMP regulations for finished
pharmaceuticals conducted in 1983, FDA examined its other regulations
affecting drug manufacturers. As a consequence, duplicate CGMP
provisions appearing in 21 CFR 314 were removed in 1985. No significant
amendments to these regulations which affect recordkeeping have been
made since that time. The information required by the CGMP regulations
is not available from any other source except the manufacturer. No other
government agency collects these data.

**5. [Involvement of Small Entities]{.underline}**

FDA must ensure that regulated products from all manufacturers (large
and small) are safe and effective, a goal achieved through equal
application of the law. It is not possible to provide exemption or
reduce requirements for small businesses without seriously compromising
public health objectives. In order to provide assistance to small
business, FDA has a small business

coordinator and small business field representatives who exclusively
help small businesses whose products are regulated by FDA. These
individuals are expressly available to deal with the special concerns of
small firms. They provide information that clarifies how FDA laws and
regulations apply to specific circumstances and suggest methods of
meeting these requirements. They respond to inquiries, conduct or
participate in workshops and conferences, or visit plants at request to
offer assistance. In addition, each Center within FDA has an appropriate
small business contact person who can also help to set up workshops and
conferences, provide informational materials or audio visuals, or
provide speakers for professional meetings.

**6. [Consequences if Information Collected Less
Frequently]{.underline}**

The prescribed frequency for the collection of information is based upon
FDA's statutory responsibility to assure the availability of uniformly
high quality drug products to the nation. FDA assures compliance with
CGMP recordkeeping requirements by conducting drug establishment
inspections, as authorized by section 704 (21 U.S.C. 374) of the act, to
review and evaluate the adequacy of records. Drug manufacturers are, in
general, scheduled for these comprehensive on-site inspections once
every two years. Inspections are scheduled more frequently when there
have been some compliance problems. FDA investigators are authorized to
examine and to copy and verify these records in order to document
evidence of deviation should an enforcement case go to litigation. It
would be impossible to ensure compliance with section 501(a)(2)(B) of
the act (21 U.S.C.351 (a)(2)(B)) if industry were not required to
maintain these records.

**7. [Consistency with the Guidelines in 5 CFR 1320.6]{.underline}**

Data collection for applications is consistent with all the requirements
of section 1320.6.

**8. [Consultation Outside the Agency]{.underline}**

In the *Federal Register* of February 7, 2002, (63 FR 5825), the agency
requested comments on this proposed collection of information. No
comments were received that pertained to the information collection.

The agency engages in a continuous dialog with industry and all
interested parties regarding the CGMP regulations, evolving standards,
and attendant recordkeeping requirements. Formal correspondence most
relevant to CGMP recordkeeping takes the form of comments to *Federal
Register* notices, such as proposed rules. For example, 115 respondents
commented on the May 3, 1996 *Federal Register* proposal to amend the
CGMP regulations. These included pharmaceutical organizations,
individual manufacturers, industry consultants, academia, attorneys, and
others. The major respondents include:

Compressed Gas Association Arlington, VA

PhRMA (Pharm. Research & Mfgs of America) Washington DC

PDA (Parenteral Drug Assoc) Bethesda, MD

NDMA (Nonprescription Drug Mfgs Assoc)Washington, DC

CTFA (Cosmetic, Toiletry & Frag. Assoc)Washington, DC

GPIA Washington, DC

Parenteral Society Swindon, UK

Animal Health Institute Alexandria, VA

Pharmaceutical Research Institute Raritan, NJ

American Association of Blood Banks Washington, DC National Welder's
Supply Assoc. Philadelphia, PA

Abbott Laboratories Abbott Park, IL

GlaxoWellcome Zebulon, NC

Geneva Pharmaceuticals, Inc. Broomfield, CO

Ciba Geigy Corporation, Summit, NJ

Janssen Pharmaceutical Research Foundation Titusville, NJ

Becton Dickinson & Co Franklin Lakes, NJ

Schering - Plough Corporation Union, NJ

Hoffman - La Roche, Inc. Nutley, NJ

Rhone Poulenc Rorer Collegeville, PA

St. John's University Jamaica, NY

University of Iowa Iowa City, IA

Massachusetts Biotechnology Council Cambridge, MA

Department of the Army Tacoma, WA

American Red Cross Washington, DC

Paul G. King, Ph.D. Lake Hiawatha, NJ

Kemper - Masterson, Inc. Belmont, MA

AAC Consulting Group, Inc. Bethesda, MD

King & Spaulding Washington, DC

The agency also participates actively in numerous seminars and
conferences sponsored by industry and academia. At such gatherings
agency staffers engage in informal but nonetheless intensive and
extensive discussions about CGMPs; recordkeeping is almost always a
topic of discourse. The Division of Manufacturing and Product Quality
(the CDER unit having primary responsibility for the CGMP regulations)
routinely gives as many as 200 presentations annually to industry
representatives.

**9. [Remuneration of Respondents]{.underline}**

No payment or gift was provided to respondents.

**10. [Assurance of Confidentiality]{.underline}**

Certain data and information collected during an inspection of a drug
manufacturing establishment for the purpose of enforcing compliance with
the CGMP regulations are considered confidential and not releasable to
the public. Confidentiality is maintained for trade secret or
confidential, commercial or financial information under 21 CFR 20.61 and
investigatory records under 21 CFR 20.64. In addition, certain
subparagraphs of 21 CFR 314.430 and 514.11 provide confidentiality of
information contained in NDAs, ANDAs, and NADAs.

**11. [Questions of a Sensitive Nature]{.underline}**

There are no questions of a sensitive nature.

**12. [Estimates of Annualized Hour Burden]{.underline}**

The burden estimates for the recordkeeping requirements in the table
below are based on FDAs institutional experience regarding creation and
review of such procedures and similar recordkeeping requirements, and
data provided to FDA to prepare an economic analysis of the potential
economic impact of the May 3, 1996, proposed rule entitled Current Good
Manufacturing Practice: Amendment of Certain Requirements for Finished
Pharmaceuticals (61 FR 20104). Annual SOP maintenance is estimated to
involve 1 hour annually per SOP, totaling 25 hours annually per
recordkeeper.

The May 3, 1996, proposed rule revising part 211 CGMP requirements would
require additional SOPs. Cost estimates for those additional SOPs were
included in the proposed rule, but are not included here. Any comments
on those estimates will be evaluated in any final rule based on that
proposal.

FDA estimates the total burden of this collection of information as
follows:

+------------+---------+------------+----------+---------+------------+
| *          |         |            |          |         |            |
| *Estimated |         |            |          |         |            |
| Annual     |         |            |          |         |            |
| Rec        |         |            |          |         |            |
| ordkeeping |         |            |          |         |            |
| Burden**   |         |            |          |         |            |
+============+=========+============+==========+=========+============+
|            |         |            |          |         |            |
+------------+---------+------------+----------+---------+------------+
| **21 CFR** | *       | **Annual   | **Total  | **Hours | **Total    |
|            | *Number | Frequency  | Annual   | per     | Hours**    |
| *          | of      | of         | R        | Re      |            |
| *Section** | Re      | Recor      | ecords** | cord-** |            |
|            | cord-** | dkeeping** |          |         |            |
|            |         |            |          | **k     |            |
|            | **ke    |            |          | eeper** |            |
|            | epers** |            |          |         |            |
+------------+---------+------------+----------+---------+------------+
| SOP        | 4,184   | 1          | 4,184    | 25      | 104,600    |
| M          |         |            |          |         |            |
| aintenance |         |            |          |         |            |
|            |         |            |          |         |            |
| (See       |         |            |          |         |            |
| previous   |         |            |          |         |            |
| list of 25 |         |            |          |         |            |
| SOPs)      |         |            |          |         |            |
+------------+---------+------------+----------+---------+------------+
| New        | 100     | 25         | 2500     | 20      | 50,000     |
| start-up   |         |            |          |         |            |
| SOPs       |         |            |          |         |            |
+------------+---------+------------+----------+---------+------------+
| 211.34     | 4,184   | .25        | 1,046    | .5      | 523        |
+------------+---------+------------+----------+---------+------------+
| 211.67(c)  | 4,184   | 50         | 209,200  | .25     | 52,300     |
+------------+---------+------------+----------+---------+------------+
| 211.68     | 4,184   | 2          | 8,368    | 1       | 8,368      |
+------------+---------+------------+----------+---------+------------+
| 211.68(a)  | 4,184   | 10         | 41,840   | .5      | 20,920     |
+------------+---------+------------+----------+---------+------------+
| 211.68(b)  | 4,184   | 5          | 20,920   | .25     | 5,230      |
+------------+---------+------------+----------+---------+------------+
| 211.72     | 4,184   | .25        | 1,046    | 1       | 1,046      |
+------------+---------+------------+----------+---------+------------+
| 211.80(d)  | 4,184   | .25        | 1,046    | .1      | 105        |
+------------+---------+------------+----------+---------+------------+
| 211.100(b) | 4, 184  | 3          | 12,552   | 2       | 25,104     |
+------------+---------+------------+----------+---------+------------+
| 211.105(b) | 4,184   | .25        | 1,046    | .25     | 262        |
+------------+---------+------------+----------+---------+------------+
| 211.122(c) | 4,184   | 50         | 209,200  | .25     | 52,300     |
+------------+---------+------------+----------+---------+------------+
| 211.130(e) | 4,184   | 50         | 209,200  | .25     | 52,300     |
+------------+---------+------------+----------+---------+------------+
| 211.132(c) | 1,698   | 20         | 33,960   | .5      | 16,980     |
+------------+---------+------------+----------+---------+------------+
| 211.132(d) | 1,698   | .2         | 340      | .5      | 170        |
+------------+---------+------------+----------+---------+------------+
| 211.137    | 4,184   | 5          | 2,0920   | .5      | 10,460     |
+------------+---------+------------+----------+---------+------------+
| 211.160(a) | 4,184   | 2          | 8,368    | 1       | 8,368      |
+------------+---------+------------+----------+---------+------------+
| 211.165(e) | 4,184   | 1          | 4,184    | 1       | 4,184      |
+------------+---------+------------+----------+---------+------------+
| 211.166(c) | 4,184   | 2          | 8,368    | .5      | 4,184      |
+------------+---------+------------+----------+---------+------------+
| 211.173    | 1.077   | 1          | 1,077    | .25     | 269        |
+------------+---------+------------+----------+---------+------------+
| 211.180(e) | 4,184   | .2         | 837      | .25     | 209        |
+------------+---------+------------+----------+---------+------------+
| 211.180(f) | 4,184   | .2         | 837      | 1       | 837        |
+------------+---------+------------+----------+---------+------------+
| 211.182    | 4,184   | 2          | 8,368    | .25     | 2,092      |
+------------+---------+------------+----------+---------+------------+
| 211.184    | 4,184   | 3          | 12,552   | .5      | 6,276      |
+------------+---------+------------+----------+---------+------------+
| 211.186    | 4,184   | 10         | 41,840   | 2       | 83,680     |
+------------+---------+------------+----------+---------+------------+
| 211.188    | 4,184   | 25         | 104,600  | 2       | 209,200    |
+------------+---------+------------+----------+---------+------------+
| 211.192    | 4,184   | 2          | 8,368    | 1       | 8,368      |
+------------+---------+------------+----------+---------+------------+
| 211.194    | 4,184   | 25         | 104,600  | .5      | 52,300     |
+------------+---------+------------+----------+---------+------------+
| 211.196    | 4,184   | 25         | 104,600  | .25     | 26,150     |
+------------+---------+------------+----------+---------+------------+
| 211.198    | 4,184   | 5          | 20,920   | 1       | 20,920     |
+------------+---------+------------+----------+---------+------------+
| 211.204    | 4,184   | 10         | 41,840   | .5      | 20,920     |
+------------+---------+------------+----------+---------+------------+
| **Total**  |         |            |          |         | 848,625    |
+------------+---------+------------+----------+---------+------------+

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

**13. [Estimates of Annualized Cost Burden to Respondents]{.underline}**

FDA\'s Economics Staff estimates that the 2001 adjusted hourly earnings
for industry compliance with 21 CFR 211 is \$31.51 (source: Occupational
Employment Statistics; 2000 National Industry-Specific Occupational
Employment and Wage Estimates; SIC 283 - Drugs). Therefore, the total
industry cost to comply with the annual burden hours estimated above is
\$26,740,173.75 (\$31.51 x 848,625).

**14. [Estimates of Annualized Cost Burden to the
Government]{.underline}**

FDA\'s Office of Compliance estimates that the current (2002) number of
FTEs (Full Time Equivalents) devoted to enforcement and oversight of the
recordkeeping burden resulting from 21 CFR 211 is 283. If each FTE
equals about \$100,000, the total cost burden to FDA would be
\$28,300,000.00.

**15. [Changes in Burden]{.underline}**

There are no changes in the burden estimates.

**16. [Time Schedule, Publication, and Analysis Plans]{.underline}**

There are no time schedules, publications, and analysis plans.

**17. [Exemption for Display of Expiration Date]{.underline}**

There is no display of the expiration date.

**18. [Certifications]{.underline}**

There are no certifications needed.

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