**Supporting Statemen**t

**Agency Information Collection**

**Transmittal of Advertisements and Promotional Labeling for Drugs and
Biologics**

**For Human Use (Form FDA 2253)**

**OMB No. 0910-0376**

**Docket No. 00N-1637**

**[Justification]{.underline}**

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

The Food and Drug Administration (FDA) is requesting Office of
Management and Budget (OMB) approval of the information collection
requirements contained in 21 CFR 314.82(b)(3)(i).

These requirements are listed below:

314.81(b)(3)(i) Reporting Other Reporting-Advertisements and promotional
labeling. The applicant shall submit specimens of mailing pieces and any
other labeling or advertising devised for promotion of the drug product
at the time of initial dissemination of the labeling and at the time of
initial publication of the advertisement for a prescription drug
product.

Statutory authority for the collection of this information for drugs is
provided by section 505(k) of the Federal Food, Drug, and Cosmetic Act
(the Act) (21 U.S.C. 355(k)). Additionally, FDA regulations require the
submission of advertisements and promotional labeling for drugs and
biologics with the transmittal Form FDA 2253 under 21 CFR
314.81(b)(3)(i).

Statutory authority for the collection of this information for biologics
is provided by Sec. 351 of the PHS act (42 U.S.C. 262) and by the Final
Rule published in the [Federal Register]{.underline} (Vol. 62, Num. 142,
p. 300-3) (Advertisements and promotional labeling may be submitted to
the Center for Biologics Evaluation and Research using either Form FDA
2253 or Form FDA 2567 (Transmittal of Labels and Circulars).

**2. [How, By Whom, and for What Purpose]{.underline}**

The Act requires that FDA protect the public health by assuring that
prescription drug information is truthful, balanced, and accurately
communicated to physicians, health care providers, and to the public.
Thus, manufacturers, packers, and distributors (sponsors) who advertise
prescription human drugs, including biological products for humans, must
disclose in advertisements and promotional labeling certain information
about the advertised products uses and risks. For example, for
prescription drugs, the Act requires advertisements to contain
information in brief summary relating to side effects,
contraindications, and effectiveness (21 U.S.C. 352(n)).

**3. [Considerations of Information Technology]{.underline}**

Sponsors currently submit specimens of promotional advertising and
labeling in hard copy. Both CDER and CBER currently have programs for
accepting electronic submissions of new drug and biologic product
license application data. Both centers published in January 2001, a
Draft Guidance for Industry\--Providing Regulatory Submissions in
Electronic Format\--Prescription Drug Advertising and Promotional
Labeling. This draft guidance is intended to show Industry that CDER and
CBER are ready to pilot the submission and review of promotional
materials, including those submitted by Form FDA 2253, and to show a
format that the agency considers effective for submitting and reviewing
promotional materials. In addition, the agency currently provides many
forms on the Internet using the World Wide Web (WWW) including Form FDA
2253 at
[http://www.fda.gov/opacom/morechoices/fdaforms/fdaforms.html.]{.underline}

4\. **[Identification of Duplication]{.underline}**

There are currently no other federal regulations that require
manufacturers of biological products licensed under Sec. 351 of the PHS
act (42 U.S.C. 262) or for manufacturers of drug products licensed under
Sec. 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) to
submit the information requested by this regulations.

5\. **[Small Business]{.underline}**

FDA believes that its duty requires the equal application of the
regulations to all enterprises. While FDA does not believe that it can
apply different standards with respect to statutory requirements, FDA
does provide special help to small businesses. A small business
coordinator has been assigned to the Commissioners staff to ensure that
small businesses have an adequate opportunity to express their concerns
and to keep the FDA management appraised of how regulatory decisions
might impact the small business community. The Center for Biologics
Evaluation and Research, Office of Communication, Training and
Manufacturers Assistance; and the Center for Drug Evaluation and
Research, Office of Training and Communication, Division of
Communications Management also provides assistance to small businesses
in dealing with FDA regulatory requirements. FDA anticipates that the
revisions to the combined form, the change to allow manufacturers of
both drugs and biologics to use one form versus two different form, and
changes to the submission procedures for multiple product submissions
will reduce burdens on all manufacturers including small businesses

6\. **[Consequences of Less Frequent Information
Collection]{.underline}**

Under the regulations, sponsors are required to submit specimens of
mailing pieces and any other labeling or advertising devised for
promotion of the drug product at the time of initial dissemination of
the labeling and at the time of initial publication of the advertisement
for a prescription drug product. Less frequent submissions of
promotional materials would not allow the FDA to review promotional
materials in a timely manner to fulfill its statutory requirement to
assure that prescription drug information is truthful, balanced, and
accurately communicated.

There are no technical or legal obstacles to reducing the reporting
burden.

7\. **[Special Circumstances]{.underline}**

Reporting more frequently than quarterly:

> Under the regulation 21 CFR 314.81(b)(3)(i), the applicant shall
> submit specimens of mailing pieces and any other labeling or
> advertising devised for promotion of the drug product at the time of
> initial dissemination of the labeling and at the time of initial
> publication of the advertisement for a prescription drug product. The
> agency considers a submission frequency greater than quarterly to be
> necessary so that it can perform a timely review of promotional
> materials to fulfill its statutory requirement to assure that
> prescription drug information is truthful, balanced, and accurately
> communicated.

8\. **[Consultation with Outside Sources]{.underline}**

Pursuant to Executive Order 12866, FDA published a notice in the
[Federal Register,]{.underline} (Vol. 65 F.R. 80437) on December 21,
2000, that announced an opportunity for public comment on a proposed
extension of the information collection and Form FDA 2253. No comments
were received.

The CBER notes that some sponsors have submitted proposed promotional
materials to CBER for comment without the Form FDA 2567, and that this
has been, and continues to be, an acceptable method of submitting draft
promotional materials. However, from past experience, CBER considers
that the use of the Form FDA 2567 to accompany draft promotional
materials makes tracking and follow-up of the materials more efficient
and more timely. For example, the form provides a quick and efficient
way of providing comments to sponsors without the need for a formal
letter, which would require more time. CBER wants to emphasize that the
option of using either Forms FDA 2253 or 2567 to accompany draft
promotional materials to CBER, does in no way mandate or obligate drug
sponsors to use a form when submitting proposed promotional materials to
CDER for comment.

9\. **[Payment or Gifts to Respondents]{.underline}**

FDA has not provided and has no intentions to provide any payment or
gift to respondents under the provisions of section 314.81(b)(3)(i) or
provided by Sec. 351 of the PHS act (42 U.S.C. 262).

10\. **[Confidentiality of Information]{.underline}**

The promotional materials submitted under the postmarketing requirements
of 21 CFR 314.81 are promotional materials that have been submitted to
the agency because they were already publicly disseminated. Therefore,
the agency would release them pursuant to requests submitted under the
Freedom of Information Act (FOIA).

11\. **[Sensitive Questions]{.underline}**

No questions of a sensitive nature are required by these regulations.

12\. **[Burdens to Respondents]{.underline}**

See chart and explanation below:

+-----------+-----------+-----------+-----------+-----------+-----------+
| Estimated |           |           |           |           |           |
| Annual    |           |           |           |           |           |
| Reporting |           |           |           |           |           |
| Burden    |           |           |           |           |           |
+===========+===========+===========+===========+===========+===========+
| 21 CFR    | No. Of    | Annual    | Total     | Hours per | Total     |
| Section   | Re        | Frequency | Annual    | Response  | Hours     |
|           | spondents | per       | Responses |           |           |
|           |           | Response  |           |           |           |
|           | \(A\)     |           | \(C\)     |           |           |
|           |           | \(B\)     |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| CBER -    | 134       | 32        | 4,288     | 2         | 8,576     |
| None      |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| CDER      | 386       | 32        | 12,352    | 2         | 24,704    |
| 314.81    |           |           |           |           |           |
| (b)(3)(i) |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| Total     |           |           |           |           | 33,280    |
+-----------+-----------+-----------+-----------+-----------+-----------+

There are no capital or operating and maintenance cost associated with
this collection of information

> \(A\) Number of sponsors that submitted new drug applications
> (including applications for new antibiotics), abbreviated new drug
> applications, and abbreviated drug applications in the year 2000.
>
> \(B\) Average number (rounded to the nearest whole number) of
> submissions submitted annually per sponsor.
>
> \(C\) Total number of Form FDA 2253 submissions to CDER in the year
> 2000.

13\. **[Capital Costs]{.underline}**

No capital will be incurred because sponsors currently submit
advertising and promotional materials to the agency.

14\. **[Annualized Cost to the FDA]{.underline}**

Processing\--The agency has contracted staff to process the submitted
promotional materials pursuant to 21 CFR 314.81. The estimated
annualized cost of receiving and processing these promotional materials
is \$49, 373.

Review\--The agency estimated that a regulatory reviewer requires hour
to review each submission of promotional materials and that the cost per
hour for each reviewer is \$35.00 (GS-13 salary plus benefits). Thus,
the estimated annual cost to review the promotional materials is
\$431,445.

15\. **[Program Change or Adjustments]{.underline}**

The agency, in collaboration with sponsors, is pursuing the electronic
only submission of promotional materials. At this time we believe that
both sponsors and the agency will achieve a significant savings by
reducing archiving expenses when paper archiving is reduced.

16\. **[Publication of Information Collection Results]{.underline}**

The agency does not plan to publish results of the information
collection requirements that would be imposed by these regulations.

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

The agency is not seeking approval to exempt display of the OMB
expiration date on any forms that may be associated with this
information collection.

18\. **[Exceptions to Certification for Paperwork Reduction Act
Submissions]{.underline}**

There are no exceptions to the Certification for Paperwork Reduction Act
Submissions of Form OMB 83I.