Ss-fdama 116

SUPPORTING STATEMENT

 

SUPPLEMENTS AND OTHER CHANGES TO APPROVED NEW ANIMAL DRUG APPLICATIONS

FINAL RULE (FDAMA 116)

 

A.  JUSTIFICATION

 

1.  Circumstances Necessitating Information Collection

 

This information collection approval request is for a Food and Drug Administration (FDA) final rule to amend our regulations on supplements and other changes to an approved NADA or ANADA.  We are amending our regulations on supplements and other changes to approved new animal drug applications (NADAs) or abbreviated new animal drug applications (ANADAs) to implement the manufacturing changes provision of Section 116 of the Food and Drug Administration Modernization Act of 1997 (FDAMA).  The final rule requires manufacturers to assess the effect of a manufacturing change on the identity, strength, quality, purity, and potency of a drug as those factors relate to the safety or effectiveness of the drug.  It also sets forth requirements for changes requiring submission and approval of a supplement before the distribution of the drug made using the change, changes requiring the submission of a supplement at least 30 days prior to the distribution of the drug, changes requiring the submission of a supplement at the time of distribution of the drug, and changes to be described in an annual report.

This is a request of the reporting requirements for making manufacturing changes to approved new animal drug applications. The FDA currently requires all changes to a new animal drug application be reported in either 1) annual reports, 2) changes being effected supplements or 3) supplements requiring approval prior to distribution of the product made with the changes. FDAMA specifies that only major manufacturing changes must be reported in supplemental applications and require FDA approval prior to distributing the product made with the changes. Manufacturing changes not considered as major manufacturing changes may be reported in 1) annual reports, 2) 30-day changes being effected supplements, and 3) immediate changes being effected supplements. The following revisions in the reporting requirements, codified under proposed 21 CFR 514.8(b)(1-4) and (c)(1-4), are required to address Section 116 of FDAMA:

 Section 514.8(b)(2) of the regulation describes reporting procedures for submission and approval of a supplement prior to distribution of the drug.

 

Section 514.8(b)(3)(i) describes reporting requirements for submission of a supplement at least 30 days prior to distribution of the drug made using the change.

 

Section 514.8 (b)(3)(vi) describes requirements for a category of supplemental changes designated by the agency which allows the holder of an approved application to commence distribution of the drug involved upon receipt by the agency of a supplement for the change.

 

Section 514.8(b)(4)(iii) provides requirements for changes and updated stability data to be submitted in an annual report.

 

Section 514.8(c)(2)(ii) describes disclosure requirements for labeling changes requiring submission and approval of a supplement prior to distribution of the drug made using the change.

Section 514.8 (c)(3)(iii) provides disclosure requirements for labeling changes to be placed in effect prior to receipt of written notice of approval of a supplemental application. 

 

Section 514.8(c)(4) describes reporting requirements for changes providing for additional distributors to be reported under Records and reports (21 CFR 514.80) concerning experience with drug products for which an approved application is in effect. 

 

2. How, By Whom, Purpose of Collection

 

We use the information required in accordance with section 512(b) of the Federal Food, Drug, and Cosmetic Act to determine whether a change to an approved NADA will alter the labeling, safety, effectiveness, identity, strength, quality or purity of the new animal drug or the adequacy of the manufacturing methods, facilities or controls to preserve them.  The requested change will be approved or denied.

 

3.  Consideration Given to Information Technology

 

We encourage the submission of data electronically, and will consider any such electronic submissions which will be more efficient for industry and facilitate review by the Agency.

 

4. Identification of Information

 

The information provided is unique to the particular product or application cited. There are no other regulations that require the submission of this same information.

 

5. Small Business

 

Because of the critical nature of the products, their uses and the impact on the consumer or user, any filing of supplements for approval of an animal drug product from a small business concern is treated with the same rigorous scientific and technical review as that submitted by a large pharmaceutical firm. A small business coordinator has been established on the Commissioner's staff to ensure that small businesses have an adequate opportunity to express their concerns and to keep our management apprised of how its regulatory decisions may impact the small business community. Furthermore, we encourage sponsors, whether small or large businesses, to meet with us to discuss questions concerning submissions.

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6. Less Frequent Information Collection

 

FDA has no control over the frequency of submitting manufacturing changes in supplemental new animal drug applications. That is the prerogative of the drug sponsor. However, all minor manufacturing changes implemented during a one year period, or a statement that no manufacturing changes have been made during the year, must be reported in the next annual report to the FDA.

 

7. Information Collection Circumstances

  Required reports are consistent with 5 CFR 1320.5.

 

8.  Consultations with Persons Outside FDA

 

This regulation was subject to public comment under the Administrative Procedures Act, and public comments were addressed as part of the public rule making process. No changes have been made in the regulatory requirements as a result of comments submitted on the information collection in response to the Federal Register of October 1, 1999 (64 FR 53281). Comments are addressed in the preamble to the Final Rule.

 

9. Payment or Gift

 

There are no payments or gifts to respondents.

 

10.   Confidentiality Provisions

 

            The Center for Veterinary Medicine and the FDA are required under 21 CFR Parts 20 and 514.11 to maintain the confidentiality of all information received in conjunction with the submissions of NADAs.  Very often under the NADA, trade secrets must be submitted by the applicant to support CVM action necessary to approve a drug for use.  Trade secrets are privileged and confidential information and are treated as such.  They are defined in 21 CFR 20.61. Any unauthorized use or disclosure of trade secrets that are presented in a NADA is specifically prohibited under Section 301(j) of the Act (21U.S. C. 311 (j)).

 

            In addition to the requirements of 21 CFR 514.11, the Center exercises security precautions in the handling of documents.  A security controlled document file room, locked files, drawers and doors are required for in-house protection.  Unused documents are destroyed by shredding.  This protection is continued after approval of the drug.

 

            The Center has a Freedom of Information Officer who is responsible for administering the policies relative to the release of information.

11.   Privacy

 

            There are no questions of a sensitive nature.

 

12. Burden of Information Collection

 

           Total estimated annual reporting burden on industry is 63,560 hours as shown in the table below. The respondents, i.e., animal drug sponsors, manufacture animal drug products and submit post-approval manufacturing or labeling changes in supplemental applications or annual reports. The number forty is obtained from the average number of respondents per year.

We believe the hourly cost of assembling and submitting supplements is comparable to that of the government’s review function. Under the following heading “Annualized Cost to the Federal Government”, we calculated the government’s average hourly personnel cost at approximately $60.00 per hour. Thus, we estimate the dollar burden on industry to be $3,813,600 (63,560 hours x $60.00 per hour = $3,813,600).

 

TABLE  1    ESTIMATED ANNUAL REPORTING BURDEN 1

 

21 CFR Section	No. Of Respondents	No. Of Responses Per Respondent	Total Annual Responses	Hours per Response	Total Hours
514.8(b)(2)	40	5.9	234	100	23,400
514.8(b)(3)(i)	40	5.0	200	40	8,000
514.8(b)(3)(vi)	40	3.6	145	40	5,800
514.8(b)(4)(iii)	40	15.2	609	40	24,360
514.8(c)(2)(ii)	40	0.3	10	100	1,000
514.8(c)(3)(iii)	40	0.5	20	40	800
514.8(c)(4)	40	0.3	10	20	200
Total					63,560

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

 

 Costs to Respondents

 

There are no additional annual cost burdens to respondents.

 

14 Costs to the Federal Government

 

To calculate the number of person hours an FTE is worth, the following calculation was used:

Hours per year	Holidays	Training hours	All type leaved used	Available hrs per FTE
2080	80	100	250	1650

The dollar amount used for budgetary purposes when converting an FTE is $99,000.

The total number of supplements expected for FY2005 is based on those received in FY2004 + 1%:

1216 x 1.01 = 1228 submissions

The 1% increase is based on the expected increase in supplemental submissions due to new animal drug approvals.

The first table below shows, for each of the 514.8(b) and (c) categories, the number of submissions expected to be received in FY2005, the time required for the government to review those submissions, and the cost to the government for reviewing. The second table shows time and cost to the government of the general administrative support needed. The amount of general support needed is independent of the number of submissions.

21 CFR	Annual Submissions		Hours per Response	Total Hours	FTEs	Cost (in $)
514.8(b)(2)	234		45	10530	6.4	631,800
514.8(b)(3)(i)	200		30	6000	3.6	360,000
514.8(b)(3)(vi)	145		20	2900	1.8	174,000
514.8(b)(4)	609		20	12180	7.4	730,800
514.8(c)(2)	10		45	450	0.3	27,000
514.8(c)(3)	20		20	400	0.3	24,000
514.8(c)(4)	10		5	50	0.1	3,000
General Administrative Support Requirements				Total Hours	FTE’s	Cost (in $)
supervisory support				413	0.3	30,975
admin. support				429	0.3	21,138
doc. tracking/control				809	0.5	39,837
electronic archive				50	0.1	2,439
			Totals for review and general administrative support	34,211	21.1	2,044,989

Total estimated cost to the government is 34,211 hours, representing 21.1 FTEs and $2,044,989.

15. Reason for Changes

 

        The reduction in the estimated burden from the 1999 proposal is based on improved metrics and administrative/review processes implemented in the last few years.

 

16. Statistical Reporting

 

There is no intent on the part of the Federal Government to publish this data, nor is any general statistical analysis by the Federal Government anticipated.