**SUPPORTING STATEMENT FOR**

**COLOR ADDITIVE CERTIFICATION**

**REQUESTS AND RECORDKEEPING**

**OMB No. 0910-0216**

**SECTION A ‑ Justification**

**1. Necessity for the Information Collection**

> **Section 721(a) of the Federal Food, Drug and Cosmetic Act (the act)
> (Attachment A) provides that a color additive be deemed unsafe unless
> the color additive and its use are in conformity with a regulation
> that describes the conditions under which the color additive may be
> safely used, or unless the color additive and its use conform to the
> terms of an exemption for investigational use. If a regulation
> prescribing safe conditions of use has been issued, the color additive
> must be from a batch certified by FDA to conform to the requirements
> of that regulation and other applicable regulations, unless the color
> additive has been exempted from the certification requirement.**
>
> **Section 721(c) of the act instructs the Secretary of Health and
> Human Services (through FDA) to issue regulations providing for batch
> certification of color additives for which he finds such requirement
> to be necessary in the interest of protecting the public health. FDA's
> implementing regulations in 21 CFR part 80 specify the information
> that must accompany a request for certification of a batch of color
> additive and require certain records to be kept pending and after
> certification. FDA requires batch certification for all color
> additives listed in 21 CFR part 74 and for all color additives
> provisionally listed in 21 CFR part 82. Color additives listed in 21
> CFR part 73 are exempted from certification.**
>
> **The color additive regulations listed in 21 CFR part 80 (Attachment
> A) are summarized as follows:**
>
> **21 CFR 80.21 Request for certification.**
>
> **A request for certification must include: Name of color additive,
> manufacturer's batch number and weight in pounds, name and address of
> manufacturer, storage conditions, statement of use(s), certification
> fee, and signature of person requesting certification.**
>
> **21 CFR 80.22 Samples to accompany requests for certification.**
>
> **The request for certification must include a sample of the batch of
> color additive that is the subject of the request. The sample must be
> labeled to show: Name of color additive, manufacturer's batch number
> and weight in pounds, and name and address of the person requesting
> certification. The sample must be accompanied by a copy of the label
> or labeling to be used for the batch when it is sold.**
>
> **21 CFR 80.39 Records of distribution.**
>
> **The person to whom a certificate is issued must keep complete
> records showing the disposal of all the color additive covered by the
> certificate. Such records are to be made available upon request to any
> accredited representative of FDA until at least 2 years after disposal
> of all of the color additive.**

**2. Uses of the Information**

> **The request for certification of a batch of color additive is
> reviewed by FDA's Office of Cosmetics and Colors to verify that all of
> the required information has been included. Since the information
> required in the request for certification is unique to the specific
> batch of color additive involved, it must be generated for each batch.
> The information submitted with the request helps FDA to ensure that
> only safe color additives will be used in foods, drugs, cosmetics, and
> medical devices sold in the United States. The batch number assigned
> by the manufacturer is a means of temporary identification until a
> certification lot number has been issued by FDA. After certification,
> the manufacturer\'s batch number helps ensure that the proper batch of
> color is indeed being used under the certification lot number issued
> by FDA. In the case of a batch that has been refused certification for
> noncompliance with the regulations, the manufacturer\'s batch number
> aids in tracing the ultimate disposal of that batch of color additive.
> The batch weight serves to account for the disposal of the entire
> batch. For example, it might be used in determining whether
> uncertified color has been sold under the lot number assigned to the
> batch by FDA or, in the event of a recall after certification, to
> determine whether all unused color has been recalled. In addition, the
> batch weight is the basis for assessing the certification fee. The
> name and address of the manufacturer of the color additive being
> submitted for certification allows FDA to contact the person
> responsible for its manufacture should a question arise concerning
> compliance with the regulations. Information on storage conditions
> pending certification is used to evaluate the possibility that the
> batch could have been inadvertently or intentionally altered in a
> manner that would make the sample submitted for certification analysis
> no longer representative of the batch. It is also used when an FDA
> investigator is sent to the site; the veracity of the storage
> statements is checked during normal plant inspections. Information on
> the uses is needed to ensure that all of the proposed uses are within
> the limits of the listing regulation for which the person seeking
> certification proposes that the color be certified. The statement of
> the fee on the certification request is for accounting purposes so
> that the person seeking certification can be promptly notified if any
> discrepancies appear. The information requested on the label of the
> sample submitted with the certification request is used to identify
> the sample. The regulations require an accompanying copy of the label
> or labeling to be used for the batch so that FDA can verify that the
> batch will be labeled appropriately when it enters commerce.**

**3. Use of Improved Information Technology**

> **The FDA continually seeks ways to reduce reporting burden through
> advances in information technology. Because the information being
> submitted is in the form of a letter, OCAC/DPEP has found that many
> respondents compile and arrange their submissions by personal computer
> using word processing software. Submission capability by this medium
> reduces the reporting burden for respondents.**

**4. Efforts to Avoid Duplication and Unavailability of Similar
Information**

> **To the best of our knowledge, no other federal government agency is
> engaged in the collection of this information. No other government
> agency has either the necessity or the authority to request the
> information required in a request for certification of a color
> additive.**

**5. Methods to Minimize Burden on Small Businesses**

> **This information collection may include small businesses. The
> information needed to assure the safety of certifiable color additives
> is established by the act, and there is no authority to abrogate the
> information criteria based on the size of a business. However, data
> collection and recordkeeping are expected to increase with the size of
> a color additive manufacturer and the number of batches of color
> additive certified. Large manufacturers with large production capacity
> submit the vast majority of requests for certification. Small
> manufacturers submit correspondingly smaller numbers of requests. FDA
> aids small businesses in complying with certification requirements
> through the Office of Small Manufacturers Assistance and through its
> scientific and administrative staffs.**

**6. Consequences if Data Were Not Collected or Collected Less
Frequently**

> **The information in the request for color additive certification is
> required by the act and by regulations and is necessary to assure the
> safety of a batch of color additive. Certification of batches of color
> additives without the required information would be illegal and would
> have the potential for jeopardizing the public health.**

**7. Special Circumstances Involving Information Collection**

> **There are no special circumstances involving this information
> collection. Submission of the information is required by the act and
> by regulations. Therefore compliance is mandatory.**

**8. Consistency with 5 CFR 1320.8(d)**

> In accordance with the Paperwork Reduction Act of 1995, FDA published
> a 60-day notice in the Federal Register of April 13, 2001 (66 FR
> 19174) (Attachment C), in which the agency requested comments on the
> Color Additive Certification Program. No comments were received from
> the public.
>
> **The regulations governing the information submitted in requests for
> color additive certification were established by the notice and
> comment rulemaking process approximately 25 years ago. Since then, FDA
> personnel in OCAC/DPEP have been in continous communication with
> representatives of the regulated industry by mail, telephone, and
> occasional personal visits. In addition, FDA has conducted regular
> inspections of domestic certifiable color manufacturers, usually every
> 3 years. An integral part of these inspections is a discussion period
> in which manufacturer personnel and the FDA inspectors exchange
> questions and viewpoints. During this time, FDA has received no
> complaints about the format or the content of the required requests
> for certification. Although FDA has not asked industry representatives
> about their attitudes toward the information required in the request
> for certification, no FDA personnel have ever heard any objections to
> furnishing this information and FDA has received no written
> communications or requests for formal sessions regarding this
> information collection. FDA personnel have found that industry
> representatives generally ask about FDA's certification analytical
> procedures and regulatory decisions and not about the information
> required in the certification requests. In addition, FDA receives
> questions from new companies seeking help with first time
> certification requests.**

**9. Payment or Gift to Respondents**

> **There are no payments or gifts provided to respondents.**

**10. Assurance of Confidentiality**

> **Because information that could be considered of competitive interest
> is collected in both the requests for color additive certification and
> in the chemical analysis of submitted samples, all color additive
> certification files are maintained in a secured area. Only information
> found releasable under FDA compliance with the Freedom of Information
> Act is released to the public. The information is also safeguarded by
> Section 301(j) of the act.**

**11. Sensitive Questions**

> **Color additive certification requests do not contain questions
> pertaining to sexual behavior, attitude, religious beliefs, or any
> other matters that are commonly considered to be private or of a
> sensitive nature.**

**12. Respondent Hour Burden and Hour Burden Cost**

**(a) Hour Burden**

> **The estimated total annual burden for this information collection is
> 2,172 hours. The estimated total response burden for this information
> collection is 1,086 hours and the estimated total recordkeeping burden
> for this information collection is 1,086 hours. Over the period fiscal
> year (FY) 1998 to FY 2000, FDA processed an average of 4,344 requests
> each year for certification of batches of color additives.
> Approximately 41 different respondents submitted requests each year.
> FDA estimates an average of 0.25 hour per total response, for the
> length of time necessary to prepare certification requests and
> accompanying samples, and an average of 0.25 hour per response for
> recordkeeping. FDA obtained the response and recordkeeping burden
> estimates from industry program area personnel.**
>
> FDA estimates the burden of this collection of information as follows:

  ------------------------------------------------------------------------------
            Estimated                                                 
            Annual                                                    
            Reporting                                                 
            Burden                                                    
  --------- ------------- -------------- ----------- ---------------- ----------
  21 CFR    No. of        Annual         Total       Hours per        Total
  Section   Respondents   Frequency per  Annual      Response         Hours
                          Response       Responses                    

  80.21     41            106            4,346       0.2              869

  80.22     41            106            4,346       0.05             217

  Total                                              0.25             1,086
  ------------------------------------------------------------------------------

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

  -------------------------------------------------------------------------------------
  Estimated                                                                  
  Annual                                                                     
  Recordkeeping                                                              
  Burden                                                                     
  --------------- --------------- --------------- ----------- -------------- ----------
  21 CFR Section  No. of          Annual          Total       Hours per      Total
                  Recordkeepers   Frequency of    Annual      Recordkeeper   Hours
                                  Recordkeeping   Records                    

  80.39           41              106             4,346       0.25           1,086

  Total                                                                      1,086
  -------------------------------------------------------------------------------------

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

**(b) Hour Burden Cost**

> **Over the period FY 1998 to FY 2000, FDA processed an average of
> 4,346 requests for certification of batches of color additives. Over
> this period, fees averaging approximately 3 million dollars per year
> were collected to fund the program. Assuming that paper work not
> normally incurred in the course of business and required for obtaining
> certification of a color additive required ½ person hour per batch of
> color and that a person hour costs \$20, then \$43,460 was devoted to
> this task, or approximately 1.5% of the fees for obtaining
> certification.**

**13. Respondent Cost Burden**

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

**14. Estimated Costs to Federal Government**

> **Section 721(e) of the act provides that fees must be charged for
> color additive certification "as may be necessary to provide,
> maintain, and equip an adequate service for such purposes." Thus it is
> required by law that there be no cost for color additive certification
> to the federal government. The scale of fees charged for certification
> of color additives is given in 21 CFR 80.10.**

**15. Changes in Burden**

> **There is an adjustment of +126 hours difference in the current
> burden over that of the last clearance. The numbers of batches
> certified per year over the last few years has remained relatively
> steady and it is anticipated that this overall trend will continue.
> The slight increase in burden is due to an average increase in sales
> by the color additive manufacturers.**

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

> **No comprehensive tabulation of the data is planned or anticipated.**

**17. Displaying of OMB Expiration Date**

> **The agency is not seeking to not display the expiration date for OMB
> approval of the information collection.**

**18. Exceptions to the Certification Statement - Item 19**

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

**SECTION B**

**Collections of Information Employing Statistical Methods**

> **The collection of information in the Color Additive Certification
> Program does not employ statistical methods.**

**Attachment A**

**Statutes and Regulations**

**Attachment B**

**COLOR ADDITIVE CERTIFICATE**

**and**

**ANALYTICAL RESULTS**

**Attachment C**

**60 Day Notice for Public Comment**