SUPPORTING STATEMENT

REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF

DRUGS IN COMMERCIAL DISTRIBUTION

Docket No. 00N-1567

OMB No. 0910-0045

A. [Justification]{.underline}

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

Under section 510 of the Federal Food, Drug, and Cosmetic Act (the act),
(21 U.S.C. 360), FDA is authorized to establish a system for
registration of producers of drugs and for listing of drugs in
commercial distribution. To implement Section 510 of the act, FDA issued
part 207 (21 CFR part 207). Under 21 CFR 207.20, manufacturers,
repackers, and relabelers that engage in the manufacture, preparation,
propagation, compounding, or processing of human or veterinary drugs and
biological products, including bulk drug substances and bulk drug
substances for prescription compounding, and drug premixes as well as
finished dosage forms, whether prescription or over-the-counter (OTC),
are required to register their establishment. In addition,
manufacturers, repackers, and relabelers are required to submit a
listing of every drug or biological product in commercial distribution.
Owners or operators of establishments that distribute, under their own
label or trade name, a drug product manufactured by a registered
establishment are not required either to register or list. However,
distributors may elect to submit drug listing information in lieu of the
registered establishment that manufactures the drug product. Foreign
drug establishments must also comply with the establishment registration
and product listing requirements if they import or offer for import
their products into the United States.

Under §§ 207.21 and 207.22, establishments must register with FDA by
submitting Form FDA-2656 (Registration of Drug Establishment) within 5
days after beginning the manufacture of drugs or biologicals, or within
5 days after the submission of a drug application or biological license
application. In addition, establishments must register annually by
returning, within 30 days of receipt from FDA, Form FDA-2656e (Annual
Update of Drug Establishment). Changes in individual ownership,
corporate or partnership structure location, or drug-handling activity
must be submitted as amendments to registration under § 207.26 within 5
days of such changes. Distributors that elect to submit drug listing
information must submit a Form FDA-2656 to FDA and a copy of the
completed form to the registered establishment that manufactured the
product to obtain a labeler code. Establishments must, within 5 days of
beginning the manufacture of drugs or biologicals, submit to FDA a
listing for every drug or biological product in commercial distribution
at that time by using Form FDA-2657 (Drug Product Listing). Private
label distributors may elect to submit to FDA a listing of every drug
product they place in commercial distribution. Registered establishments
must submit to FDA drug product listing for those private label
distributors who do not elect to submit listing information by using
Form FDA-2658 (Registered Establishments\' Report of Private Label
Distributors).

Under § 207.25, product listing information submitted to FDA must,
depending on the type of product being listed, include any new drug
application number or biological establishment license number, copies of
current labeling and a sampling of advertisements, a quantitative
listing of the active ingredient for each drug or biological product not
subject to an approved application or license, the NDC number, and any
drug imprinting information.

In addition to the product listing information required on Form
FDA-2657, FDA may also require, under § 207.31, a copy of all
advertisements and a quantitative listing of all ingredients for each
listed drug or biological product not subject to an approved application
or license; the basis for a determination, by the establishment, that a
listed drug or biological product is not subject to marketing or
licensing approval requirements; and a list of certain drugs or
biological products containing a particular ingredient. FDA may also
request, but not require, the submission of a qualitative listing of the
inactive ingredients for all listed drugs or biological products, and a
quantitative listing of the active ingredients for all listed drugs or
biological products subject to an approved application or license.

Under § 207.30, establishments must update their product listing
information by using Form FDA-2657 and/or Form FDA-2658 every June and
December or, at the discretion of the establishment, when any change
occurs. These updates must include the following information: A listing
of all drug or biological products introduced for commercial
distribution that have not been included in any previously submitted
list; all drug or biological products formerly listed for which
commercial distribution has been discontinued; all drug or biological
products for which a notice of discontinuance was submitted and for
which commercial distribution has been resumed; and any material change
in any information previously submitted. No update is required if no
changes have occurred since the previously submitted list.

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

The information obtained from the establishment registration forms FDA
2656 and FDA 2656e is used by FDA and other government agencies to keep
an accurate and current list of all human and animal drug manufacturers,
repackers, relabelers and other drug processors located in this country.
This list is used by FDA for inspectional purposes as required by the
Act. In addition, the data is used by the public and private sector as a
listing of the names and locations of drug firms.

The information obtained from the listing forms FDA-2657 and FDA-2658 is
used, through assignment of the National Drug Code numbers, for third
party reimbursement payment in Medicare and Medicaid as well as other
health care insurance firms. Use of the assigned NDC numbers on
insurance reimbursement forms is essential for payment. The NDC numbers
also help industry, retailers, wholesalers and so on, as well as large
government purchasing agencies such as the Defense Department, to
maintain an accurate list of drug products for inventory purposes. The
data obtained from the listing forms is also used by FDA to determine
which products containing certain drug ingredients may be found to be
unsafe or not effective. In addition, the data is used to produce a
National Drug Code Directory to meet demands of the drug and health care
industry for a complete list of prescription drugs marketed in the
United States. The listing information is also used for the assessment
of certain user fees. If the collection of this information were not
conducted, there would be no third-party reimbursement for drugs. Also,
many systems which rely on drug inventories would be hindered as well as
FDA\'s efforts to regulate the drug industry. Concerning the drug
imprint information, poison control centers use imprinted drug codes to
help identify drug products in overdose emergencies. Consumers and
health professionals use imprinted drug codes to recognize whether a
different manufacturer\'s product has been dispensed or whether a
prescription has been incorrectly filled. Imprinting can also aid in the
prevention of emergencies caused by tampering. It can also assist law
enforcement, regulatory, and other public officials to trace counterfeit
and defective drug products.

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

FDA is currently developing and plans to propose rulemaking that would
require the electronic submission via the Internet of all registration
and listing information.

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

Although several systems do exist in FDA that have related data, they
exist for different uses. This information is not already submitted to
the agency, and thus, there is no duplicate reporting.

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

Data collection for purposes of this regulation may include small
businesses. FDA has established a Division of Small Manufacturers
Assistance to provide workshops, onsite evaluations, and other technical
assistance to small manufacturers. Each FDA Field Office has small
business representatives which help small businesses fill out forms,
discuss regulatory requirements, and provide clarification to firm
registration and drug listing matters.

6\. [Consequences If Information Collected Less Frequently]{.underline}

Information on the registration of drug firms and the listing of drug
products cannot be collected less frequently. FDA believes that in order
to fulfill its statutorily mandated responsibility under Section 510 of
the Act, the agency needs to keep its listing current with changes in
the industry.

7\. [Consistency with the Guidelines in 5 CFR 1320.5(d)(2)]{.underline}

None of the collection requirements are inconsistent with 5 CFR
1320.5(d)(2).

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

On December 11, 1997, in the notice (at 62 FR 65274) requesting
reinstatement of Registration of Producers of Drugs and Listing of Drugs
in Commercial Distribution, FDA-Forms 2656, 2656e, 2657, and 2658, FDA
invited comments on the collection of information concerning: (1)
whether the proposed collection of information is necessary for the
proper performance of FDA's functions, (2) the accuracy of FDA's
estimate of the burden of the proposed collection of information;
including the validity of the methodology and assumptions used; (3) ways
to enhance the quality, utility, and clarity of the information to be
collected; and (4) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques, when appropriate, and other forms of information
technology. There were no significant comments received.

The Information Management Team works continuously to improve its drug
listing and registration system by consulting with persons both inside
and outside the agency to obtain their views on the availability of
data, frequency of collection, the clarity of instructions, disclosure,
or reporting format and on the data elements to be disclosed or
reported.

The Team has been very active in the National Council for Prescription
Drug Program (NCPDP). Monthly contacts are made with members of this
council regarding ways to improve the drug listing program. NCPDP has
over 450 members from third party reimbursement insurance companies,
such as Blue Cross/Blue Shield, medicare, medicaid, wholesale druggists,
retail druggists, drug manufacturers, health care industry, chain
pharmacists and State and Federal governments. In addition, the Team
consults regularly with the Drug Enforcement Administration (DEA) and
other government agencies regarding drug listing data collection and
other information.

FDA is currently developing and will propose rulemaking to reorganize,
consolidate, and revise 21 CFR part 207, and to require the electronic
submission of all registration and listing information. The public will
have the opportunity to comment on the proposed rule.

**In the Federal Register** of November 2, 2000 (65 FR 65868), the
agency requested comments on the proposed collection of information. The
agency received one comment on the 60-day notice. The comment
recommended that FDA eliminate the requirement to send a representative
label and/or carton with each Form FDA 2657 and 2658, and that, instead,
the labeling would be available and submitted to FDA upon request.

FDA appreciates the recommendation concerning labeling submissions.
However, the comment is beyond the scope of the November 2, 2000,
notice. That notice provided an opportunity for public comment on the
agency\'s estimates of the burden resulting from the information
collection requirements imposed by 21 CFR 207. In the Federal Register
of November 30, 2000 (65 FR at page 73798), FDA announced as part of the
semiannual regulatory agenda that it intends to publish a proposed rule
to revise 21 CFR 207 to clarify the requirements for registration and
listing and to consolidate and reorganize the regulations. The proposal
would also require the electronic submission of establishment
registration and product listing information. It would be more
appropriate to submit the comment to that proposed rule after it
publishes in the Federal Register

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

FDA has not provided and has no intention to provide any payment or gift
to respondents under this provision.

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

Confidential information is submitted to FDA on form FDA-2657 - inactive
ingredients and amounts. Special edits are put into certain reports so
that this type of information is expurged. This type of data is kept in
limited access areas.

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

This information collection does not contain questions pertaining to
sex, behavior, attitude, religious beliefs, or any other matters that
are commonly considered private or sensitive in nature.

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

The information collection requirements of the Drug Listing and
Establishment Registration regulations have been grouped according to
the information collection areas of the regulations. The estimates are
based upon FDA\'s Information Management Team\'s data collection and
experience in regulatory drug listing and establishment registration of
manufacturers, repackers, relabelers, and other drug processors.

**ESTIMATED REPORTING BURDEN**

+---------------+----------+---------+----------+----------+----------+
| [REPORTING    | [Number  | [Number | [Total   | [Hours   | [Total   |
| ]{.underline} | of]{.un  | o       | Ann      | Per]{.un | Ho       |
|               | derline} | f]{.und | ual]{.un | derline} | urs]{.un |
|               |          | erline} | derline} |          | derline} |
|               | [        |         |          | [Respon  |          |
|               | Responde | [R      | [Respon  | ses]{.un |          |
|               | nts]{.un | esponse | ses]{.un | derline} |          |
|               | derline} | s]{.und | derline} |          |          |
|               |          | erline} |          |          |          |
|               |          |         |          |          |          |
|               |          | [Pe     |          |          |          |
|               |          | r]{.und |          |          |          |
|               |          | erline} |          |          |          |
|               |          |         |          |          |          |
|               |          | [Re     |          |          |          |
|               |          | sponden |          |          |          |
|               |          | t]{.und |          |          |          |
|               |          | erline} |          |          |          |
+---------------+----------+---------+----------+----------+----------+
| \(1\) [Form   | 15,802   | .34     | 5,438    | ½ hr.    | 2,719    |
| FDA-          |          |         |          |          |          |
| ]{.underline} |          |         |          |          |          |
|               |          |         |          |          |          |
| [2656         |          |         |          |          |          |
| ]{.underline} |          |         |          |          |          |
| Registration  |          |         |          |          |          |
| of            |          |         |          |          |          |
|               |          |         |          |          |          |
| Drug          |          |         |          |          |          |
| Establishment |          |         |          |          |          |
|               |          |         |          |          |          |
| 21 CFR 207.21 |          |         |          |          |          |
|               |          |         |          |          |          |
| 21 CFR 207.22 |          |         |          |          |          |
|               |          |         |          |          |          |
| 21 CFR 207.25 |          |         |          |          |          |
|               |          |         |          |          |          |
| 21 CFR 207.26 |          |         |          |          |          |
|               |          |         |          |          |          |
| 21 CFR 207.40 |          |         |          |          |          |
+---------------+----------+---------+----------+----------+----------+
| \(2\) [Form   | 7,226    | 1       | 7,226    | ½ hr.    | 3,613    |
| FDA-          |          |         |          |          |          |
| ]{.underline} |          |         |          |          |          |
|               |          |         |          |          |          |
| [2656e        |          |         |          |          |          |
| ]{.underline} |          |         |          |          |          |
| Annual Update |          |         |          |          |          |
| of Drug       |          |         |          |          |          |
| Establishment |          |         |          |          |          |
|               |          |         |          |          |          |
| 21 CFR 207.21 |          |         |          |          |          |
|               |          |         |          |          |          |
| 21 CFR 207.22 |          |         |          |          |          |
|               |          |         |          |          |          |
| 21 CFR 207.25 |          |         |          |          |          |
|               |          |         |          |          |          |
| 21 CFR 207.26 |          |         |          |          |          |
|               |          |         |          |          |          |
| 21 CFR 207.40 |          |         |          |          |          |
+---------------+----------+---------+----------+----------+----------+
| \(3\) [Form   | 14,381   | 2.80    | 40,270   | ½ hr.    | 20,135   |
| FDA-          |          |         |          |          |          |
| ]{.underline} |          |         |          |          |          |
|               |          |         |          |          |          |
| [2657         |          |         |          |          |          |
| ]{.underline} |          |         |          |          |          |
| Drug Product  |          |         |          |          |          |
|               |          |         |          |          |          |
| Listing       |          |         |          |          |          |
|               |          |         |          |          |          |
| 21 CFR 207.21 |          |         |          |          |          |
|               |          |         |          |          |          |
| 21 CFR 207.22 |          |         |          |          |          |
|               |          |         |          |          |          |
| 21 CFR 207.25 |          |         |          |          |          |
|               |          |         |          |          |          |
| 21 CFR 207.30 |          |         |          |          |          |
|               |          |         |          |          |          |
| 21 CFR 207.31 |          |         |          |          |          |
|               |          |         |          |          |          |
| 21 CFR 207.40 |          |         |          |          |          |
+---------------+----------+---------+----------+----------+----------+
| \(4\) [Form   | 6,221    | 2.14    | 13,289   | ½ hr.    | 6,645    |
| FDA-          |          |         |          |          |          |
| ]{.underline} |          |         |          |          |          |
|               |          |         |          |          |          |
| [2658         |          |         |          |          |          |
| ]{.underline} |          |         |          |          |          |
| Registered    |          |         |          |          |          |
|               |          |         |          |          |          |
| Est           |          |         |          |          |          |
| ablishments\' |          |         |          |          |          |
|               |          |         |          |          |          |
| Report of     |          |         |          |          |          |
| Private       |          |         |          |          |          |
|               |          |         |          |          |          |
| Label         |          |         |          |          |          |
| Distributors  |          |         |          |          |          |
|               |          |         |          |          |          |
| 21 CFR 207.21 |          |         |          |          |          |
|               |          |         |          |          |          |
| 21 CFR 207.22 |          |         |          |          |          |
|               |          |         |          |          |          |
| 21 CFR 207.25 |          |         |          |          |          |
|               |          |         |          |          |          |
| 21 CFR 207.30 |          |         |          |          |          |
|               |          |         |          |          |          |
| 21 CFR 207.31 |          |         |          |          |          |
+---------------+----------+---------+----------+----------+----------+
| Total         |          |         |          |          | 33,112   |
| Reporting     |          |         |          |          |          |
| Burden        |          |         |          |          |          |
+---------------+----------+---------+----------+----------+----------+

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

Based on an industry hourly wage average cost of \$50 per hour, the
annual cost is as follows:

Total burden hours of 33,112 @ \$50 per hour equals \$1,655,600.

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

The estimated annual operating wage costs for FDA\'s Information
Management Team is approximately \$212,000. The Branch also employs 18
contractors at an annual cost of \$1.0 million. In addition, the
Division spends approximately \$100,000 per year for computer
hardware/software and mainframe use. FDA field support for drug firm
registration and drug listing matters, including instructing firms on
how to complete forms and compliance, is estimated at \$75,000 per year.
Therefore, the total cost to FDA is approximately \$1,387,000 annually.

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

The decrease from \$1,972,000 to \$1,387,000 is because of reduced costs
for FDA personel and the private contractors, and the decrease from
40,383 to 33,112 total burden hours is because of a lower number of
registration and listing respondents and responses.

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

No comprehensive tabulation of the data is planned or anticipated.

17\. [Displaying of OMB Expiration Date]{.underline}

The FDA Forms involved in this collection will display the OMB
expiration date.

18\. [Exception to the Certification Statement - Item 19]{.underline}

There are no exceptions to the certification statement identified in
Item 19, " Certification for Paperwork Reduction Act Submission," of OMB
Form 83-I.

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