**SUPPORTING STATEMENT**

**State Petitions for Exemption from Preemption (21 CFR 100.1(d))**

**OMB No. 0910-0277**

**A. JUSTIFICATION**

**1. Necessity for the Information Collection**

> The Nutrition Labeling and Education Act of 1990 (the 1990 amendments)
> amended the Federal Food, Drug, and Cosmetic Act (the act) by adding
> section 403A(a) (21 U.S.C. 343-1(a)) to provide for national uniform
> nutrition labeling by providing for the preemption of certain types of
> State and local labeling requirements that are not identical to
> applicable Federal requirements; e.g., food standards, nutrition
> labeling, health claims, and ingredient declaration requirements
> (Attachment A).
>
> The 1990 amendments also added section 403A(b)(21 U.S.C. 343-1(b))
> that permits the States to petition the Food and Drug Administration
> (FDA) for exemption of State requirements from Federal preemption of
> State food labeling and standard of identity requirements. FDA may
> grant the petition for exemption if the State shows that the State
> requirement: (1) would not cause any food to be in violation of any
> applicable requirement under Federal law, (2) would not unduly burden
> interstate commerce, and (3) is designed to address a particular need
> for information which need is not met by the requirements of the
> sections referred to in section 403A(a)of the act (Attachment A).
>
> FDA has established procedural regulations in 21 CFR Part 100
> pertaining to the submission of State petitions requesting exemption
> from Federal preemption. These procedural regulations address the
> content and substance of the information that the State is required to
> supply to meet the statutory requirements for obtaining an exemption
> from preemption.
>
> This is a request for extension by OMB of its approval of the
> information collection requirements in the following citation
> (Attachment B):
>
> **21 CFR 100.1(d)- Reporting**
>
> Sets forth data requirements for State petitions requesting exemption
> from Federal preemption.

**2. How, by Whom, and for What Purpose the Information is Used**

> Under section 403A(b) of the act (21 U.S.C. 343-1(b)), States may
> petition FDA for exemption from Federal preemption of State food
> labeling and standard of identity requirements. Section 100.1(d) (21
> CFR 100.1(d)) sets forth the information a State is required to submit
> in such a petition. The information required under §100.1(d) enables
> FDA to determine whether the State food labeling or standard of
> identify requirement satisfies the criteria of section 403A(b) for
> granting exemption from preemption. The consequences of not specifying
> in §100.1(d) the information to be collected would be a reduced
> likelihood that a petition for exemption from preemption would meet
> the statutory requirements for obtaining an exemption.
>
> In the last three years, FDA has received no petitions from State
> agencies seeking exemption from preemption of Federal provisions for
> certain local requirements.

**3. Consideration of Information Technology**

> The regulation for State petitions for exemption from preemption does
> not prescribe the use of automated, electronic, mechanical, or other
> technological techniques of other forms of information technology as
> necessary for use by the States. States are free to use whatever form
> of information technology may best assist them in the development of
> their petition.

**4. Identification of Duplication and Similar Information Already
Available**

> An exemption granted under §100.1 is granted only to the petitioning
> State. Exemption from preemption is largely based on an evaluation of
> a unique situation within a State. It is possible that a situation
> could arise that is more national in scope that would require
> duplicate petitions pertaining to the same subject submitted by one or
> more States. In such a case, the agency would consider amendment of
> the Federal requirement because the action requested would be more
> universal than that envisioned by Congress in providing the exemption.
> Because the preemption provisions of section 403A(a) apply only to
> statutes and regulations administered by FDA, there is no likelihood
> of Federal duplication of effort.

**5. Small Business**

> The provisions of this regulation are specific to State and local
> governments and are not applicable to small businesses.

**6. Describe the Consequences If the Data Were Collected less
Frequently**

> There are no consequences to Federal program or policy activities if
> the information is not collected or is collected less frequently.

**7. Special Circumstances**

> None of the requirements are inconsistent with the guidelines in 5 CFR
> 1320.5.

**8. Outside Consultation**

In accordance with 5 CFR 1320.8(d), on January 13, 2005 (70 FR 2412), a
60-day notice for public comment (Attachment C) was published in the
Federal Register. One comment was received.  The comment expresses
concern that it is unnecessary for FDA to maintain a "program" whereby
States may petition the FDA to request exemption from preemption because
States are not asking for exemptions.  The comment asserts that the
"program" wastes taxpayer dollars and suggests that FDA abolish it. 

>  

Under section 403A(b) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 343-1(b)), States may petition FDA for exemption from
Federal preemption of State food labeling and standard of identity
requirements.  FDA's regulations at § 100.1(d) (21 CFR 100.1(d)), the
subject matter of this information collection, sets forth the
information a State is required to submit in such a petition.  Section
100.1(d) implements a statutory information collection requirement.
Therefore, FDA cannot abolish the regulations unless the statute is
changed.

**9. Gifts**

> This information collection does not provide for payment or gifts to
> respondents.

**10. Confidentiality**

> No assurance of confidentiality is given to petitioners. The
> regulation provides in §100.1(e) that public disclosure of State
> petitions will be governed by the rules specified in 21 CFR 10.20(j).

**11.** **Sensitive Questions**

> This information collection does not involve any questions of a
> sensitive nature.

**12. Respondent Hour Burden and Annualized Burden Hour Costs**
**Estimates**

> [Burden Hours]{.underline}.

+------------+-----------+---------------+-----------+---------+------+
| *          |           |               |           |         |      |
| *Estimated |           |               |           |         |      |
| Annual     |           |               |           |         |      |
| Reporting  |           |               |           |         |      |
| B          |           |               |           |         |      |
| urden^1^** |           |               |           |         |      |
+============+===========+===============+===========+=========+======+
| ^21\ CF    | ^No.\ of^ | ^Annua        | ^Total    | ^Hour   | ^To  |
| \ Section^ |           | l\ Frequency^ | \ Annual^ | s\ per^ | tal^ |
|            | ^Res      |               |           |         |      |
|            | pondents^ | ^p            | ^R        | ^Re     | ^Ho  |
|            |           | er\ Response^ | esponses^ | sponse^ | urs^ |
+------------+-----------+---------------+-----------+---------+------+
| ^100.1(d)^ | ^1^       | ^1^           | ^1^       | ^40^    | ^40^ |
+------------+-----------+---------------+-----------+---------+------+

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

> FDA expects that the burden hours for this information collection in
> the future will be insignificant. In the last three years, FDA has
> received no petitions from State agencies seeking exemption from
> preemption of Federal provisions for certain local requirements.
> Although FDA believes that the burden will be insignificant, it
> believes these information collection provisions should be extended to
> provide for the potential future need of a State or local government
> to petition for an exemption from preemption under the provisions of
> section 403(A)(b) of the act.

[Estimated Annualized Cost for the Burden Hours]{.underline}.

> FDA estimates annualized hour burden cost to respondents for
> completion and submission will be insignificant.

**13. Estimated Costs Burden to Respondents**

> There are no capital costs or operating and maintenance costs
> associated with this collection.

**14. Annualized Costs to Government**

> The annualized cost to the Federal government for the review and
> evaluation of petitions submitted under §100.1(d) is \$1,384. The cost
> is estimated as being equivalent to 40 hours of review and evaluation
> per year at a GS-13/Step-1 salary rate of \$34.61/hr for the
> Washington-Baltimore locality pay area for the year 2004. The
> estimated cost of \$1,384.40 (40 hrs x \$34.61/hr) is rounded to
> approximately \$1,384/yr.

**15. Changes in Burden**

> The hour burden is unchanged.

**16. Statistical Analysis, Publication Plans, and Schedule**

> The information obtained from this data collection will not be
> published.

**17. Approval Not to Display Expiration Date**

No approval is requested.

**18. Exception to Certification Statement**

> No exceptions requested.

**B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS**

This collection of information does not employ statistical methods.