**SUPPORTING STATEMENT**

**PREMARKET NOTIFICATION FOR A NEW DIETARY INGREDIENT**

**21 CFR Section 190.6**

**0910-0330**

**A. JUSTIFICATION**

**1. Circumstances That Make Collection of Information Necessary.**

> The Dietary Supplement Health and Education Act (DSHEA) amended the
> Federal Food, Drug, and Cosmetic Act (the act) by adding section
> 413(a) (21 U.S.C. 350b(a)). Section 413(a) of the act (Attachment A)
> provides that a manufacturer or distributor must notify the Secretary
> (and by delegation FDA) at least 75 days before the introduction or
> delivery for introduction into interstate commerce of a new dietary
> ingredient or a dietary supplement containing it. This notification
> must include an explanation of the manufacturer's or distributor's
> basis for concluding that the new dietary ingredient or a dietary
> supplement containing it will reasonably be expected to be safe.
>
> FDA established Federal regulations at 21 CFR §190.6 (Attachment B)
> that provide the details of the administrative procedures associated
> with a new dietary ingredient pre-market notification. These
> regulations identify the type of information that must be submitted in
> a written notification in order to meet the requirements of section
> 413 of the act. This documentation must include copies of any
> published articles or other information the manufacturer or
> distributor cited in support of the determination that the new dietary
> ingredient or a dietary supplement containing it will reasonably be
> expected to be safe.
>
> We request the extension of the OMB approval for information
> collections contained in the following citation:
>
> **21 CFR §190.6 - Reporting**
>
> Requires submission of a pre-market notification at least 75 days
> before a new dietary ingredient or a dietary supplement that contains
> a new dietary ingredient can be introduced or delivered for
> introduction into interstate commerce.

**2. Purpose of Information Collection**

> The DSHEA required the reporting requirements that are the subject of
> this regulation. This information is used by the manufacturer or
> distributor of a dietary supplement that contains a new dietary
> ingredient, or of the new dietary ingredient to inform FDA of the
> basis on which it has concluded that the dietary supplement containing
> such dietary ingredient will reasonably be expected to be safe. FDA
> uses this information to determine whether there is any basis for
> concern about the marketing of the dietary supplement containing the
> new dietary ingredient.

**3. Use of Improved Information Technology**

> The agency is not equipped to receive these submissions
> electronically, therefore, this reporting requirement will not involve
> the use of automated, electronic, mechanical, or other technological
> collection techniques or other forms of information technology.

**4. Duplication**

> The FDA is the only Federal agency that collects this information.
> There are no similar data that can be used or modified for this use.
> This notification is only given when the manufacturer or distributor
> is introducing or delivering for introduction into interstate commerce
> a new dietary ingredient or a dietary supplement containing such new
> dietary ingredient. Therefore, the information being submitted to the
> agency will be original for each submission.

**5. Small Business**

> The reporting requirements of this regulation are those mandated by
> the DSHEA and the agency has tentatively concluded that they will not
> be a burden to small businesses.

**6. Frequency of Reporting**

> The information is only collected if a manufacturer or distributor is
> introducing or delivering for introduction into interstate commerce a
> dietary supplement that contains a new dietary ingredient. If the
> collection is not conducted or is conducted less frequently,
> manufacturers or distributors of the subject product will not be in
> compliance with section 413(a) of the Federal Food, Drug, and Cosmetic
> Act.

**7. Special Circumstance of Information Collection**

> There are no special circumstances that would cause an information
> collection.

**8. Consultation Outside the Agency**

> In accordance with 5 CFR §1320.8(d), on February 7, 2005 (70 Fr 6444)
> a 60-day notice for public comment (Attachment C) was published in the
> *Federal Register*. No comments were received.

**9. Payment of Gifts**

> There has been no decision to provide any payment or gift to
> respondents.

**10. Confidentiality Provided Respondents**

> The proposed regulation does not specify confidentiality. However, all
> information received by FDA is subject to the agency\'s regulations
> concerning confidentiality in 21 CFR §20.61.

**11. Sensitive Questions**

> There are no questions of a sensitive nature.

**12. Estimate of Burden**

[Burden Hours]{.underline}

> FDA believes that there will be minimal burden on the industry to
> generate data to meet the requirements on the pre-market notification
> program, because FDA is requesting only that information that the
> manufacturer or distributor should already be developing to satisfy
> itself that a dietary supplement containing a new dietary ingredient
> is in full compliance with the act. However, FDA estimates that
> extracting and summarizing the relevant information from the company's
> files, and presenting it in a format that will meet the requirements
> of section 413 of the act, will require a burden of approximately 20
> hours of work per submission.
>
> During the past three fiscal years, from October 1, 2002 through
> September 30, 2004, FDA received an average of 47 notifications per
> year from an average of 1 notification per submitting manufacture or
> distributor. In comparison, during the previous three fiscal years,
> from October 1, 1999 through September 30, 2001, FDA received an
> average of 23 notifications per year from an average of 1 notification
> per submitter. The annual average number of notifications FDA received
> during fiscal years 2002-2004 increased by 24 (47 - 23 = 24). Because
> the pre-market notification program for new dietary ingredients is
> relatively new, the agency anticipates that this upward trend in
> receiving more notifications will continue over the next three fiscal
> years, from October 1, 2005 through September 30, 2007. Therefore, FDA
> estimates that it will receive an annual average of 71 notifications
> (47 + 24 = 71) from an annual average of 1 notification per submitter
> during fiscal years 2005-2007.

ESTIMATED ANNUAL REPORTING BURDEN^1^

  ----------- ------------- ------------ ----------- ----------- -----------
  21 CFR      No. of        Annual       Total       Hours per   Total Hours
  Section     Respondents   Frequency    Annual      Response    
                            per          Response                
                            Respondent                           

  190.6       71            1            71          20          1420
  ----------- ------------- ------------ ----------- ----------- -----------

> ^1^There are no capital costs or operating and maintenance costs
> associated with this collection of information.
>
> [Estimated Annualized Cost for the Burden Hours]{.underline}
>
> The total estimated annualized hour burden costs for the collection of
> an annual average of 47 notifications over the last three fiscal years
> 2002-2004 was \$26,762. This increased cost was due to a doubling of
> the total annual average number notifications industry submitted to
> FDA compared to the previous three fiscal years 1999-2001 (i.e.,
> increased from 23 to 47). Therefore, the cost to industry to prepare
> the notifications during fiscal years 2002-2004 approximately doubled
> as well compared to the three earlier fiscal years 1999-2001 (i.e.,
> increased from \$11,500 to \$26,762). The estimated costs during
> fiscal years 1999-2001 were based upon an industry employee making a
> salary equivalent to a GS-12 step 3 level in the locality pay area of
> Washington-Baltimore at \$28.47/hr in 2002 (\$28.47/hr x 20 hrs x 47
> respondents = \$26,762).
>
> The total estimated annualized hour burden costs for the collection of
> an anticipated annual average of 71 notifications over the next three
> fiscal years 2005-2007 is \$45,639. This estimate is based upon an
> industry employee making a salary equivalent to a GS-12 step 3 level
> in the locality pay area of Washington-Baltimore at \$32.14/hour in
> 2005 (\$32.14/hr x 20 hrs x 71 respondents = \$45,639).

**13. Cost to the Respondents**

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

**14. Cost to the Federal Government**

> The estimated cost to the federal government is approximately \$
> 75,699/yr (\$152,552/yr + \$35,348/yr = \$ 187,900/yr). This is based
> on the 2005 salaries of four (4) staff at the GS-13 step 5 level,
> three of whom spend an estimated 0.50 man-years and another who spends
> an estimated 0.30 man-years (0.50 FTE + 0.50 FTE + 0.50 FTE + 0.30 FTE
> = 1.80 FTE x \$84,751/yr = \$152,552/yr) for a total burden of 3244
> hrs/yr (2080 hrs/yr x 1.80 FTE = 3244 hrs/yr); and two (2) staff at
> the GS-14 step 1 level, each of whom spends an estimated 0.20
> man-years (0.20 FTE + 0.20 FTE = 0.40 FTE x \$88,369/yr = \$35,348/yr)
> for a total burden of 832 hrs/yr (2080 hrs/yr x 0.40 FTE = 832
> hrs/yr).
>
> An increase in the number of FDA staff involved with notifications is
> mainly due to two factors: an increase in the number of notifications
> the agency has received in the past and will likely receive in the
> next three fiscal years and an increase in the diversity of the types
> of new dietary ingredient substances that are the subject of
> pre-market notifications. During the last three fiscal years, the
> notifications FDA received addressed more novel ingredients compared
> to earlier years. FDA anticipates that this trend will continue in
> fiscal years 2005-2007, and will include staff with specialized
> expertise to assist in the review of safety data submitted in the
> notifications. Typically, FDA's review of a notification will involve
> staff from several disciplines, as appropriate, e.g., nutrition,
> pharmacy, chemistry, toxicology, medicine, microbiology, and botany.

**15. Change in Burden**

> The total hourly burden for manufacturers or distributors increased
> from 460 during fiscal years 1999-2001 to 700 during fiscal years
> 2002-2004 due to a doubling of the number of notifications industry
> submitted to FDA. FDA estimates that the total hourly burden for
> manufactures or distributors over the next three fiscal years
> 2005-2007 will increase from 700 to 1420, following a similar upward
> trend in the number of notifications industry is anticipated to submit
> to FDA.

**16. Publication of Collected Information**

> The information from this collection will not be published.

**17. Approval for Not Displaying Expiration Date**

> No approval requested.

**18. Exception to the Certification Statement; Item 19, OMB Form
830-I**

> No exception is requested to the certification statement identified in
> ITEM 19, \"Certification for Paperwork Reduction Act Submissions\" of
> OMB Form 830-I.

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

> This collection of information does not employ statistical methods.