Guidance for Industry on Formal Dispute Resolution; Appeals above the Division Level
0910‑0430
SUPPORTING STATEMENT
Terms of Clearance: None.
A. Justification
Circumstances Making the Collection of Information Necessary
This information collection approval request is for an FDA guidance on the process for formally resolving scientific and procedural disputes in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) that cannot be resolved at the division level. The guidance describes procedures for formally appealing such disputes to the office or center level and for submitting information to assist center officials in resolving the issue(s) presented. The guidance provides information on how the agency will interpret and apply provisions of the existing regulations regarding internal agency review of decisions (§ 10.75) and dispute resolution during the investigational new drug (IND) process (§ 312.48) and the new drug application/abbreviated new drug application (NDA/ANDA) process (§ 314.103). In addition, the guidance provides information on how the agency will interpret and apply the specific Prescription Drug User Fee Act (PDUFA) goals for major dispute resolution associated with the development and review of PDUFA products.
Existing regulations, which appear primarily in parts 10, 312, and 314 (21 CFR parts 10, 312, and 314), establish procedures for the resolution of scientific and procedural disputes between interested persons and the agency, CDER, and CBER. All agency decisions on such matters are based on information in the administrative file (§ 10.75(d)). In general, the information in an administrative file is collected under existing regulations in parts 312 (OMB Control No.0910‑0014), 314 (OMB Control No. 0910‑0001), and part 601 (21 CFR part 601) (OMB Control No. 0910‑0338), which specify the information that manufacturers must submit so that FDA may properly evaluate the safety and effectiveness of drugs and biological products. This information is usually submitted as part of an IND, NDA, or biologics license application (BLA), or as a supplement to an approved application. While FDA already possesses in the administrative file the information that would form the basis of a decision on a matter in dispute resolution, the submission of particular information regarding the request itself and the data and information relied on by the requestor in the appeal would facilitate timely resolution of the dispute. The guidance describes the following collection of information not expressly specified under existing regulations: The submission of the request for dispute resolution as an amendment to the application for the underlying product, including the submission of supporting information with the request for dispute resolution.
Agency regulations (§§ 312.23(11)(d), 314.50, 314.94, and 601.2) state that information provided to the agency as part of an IND, NDA, ANDA, or BLA is to be submitted in triplicate and with an appropriate cover form. Form FDA 1571 must accompany submissions under INDs and Form FDA 356h must accompany submissions under NDAs, ANDAs, and BLAs. Both forms have valid OMB control numbers as follows: FDA Form 1571 - OMB Control No. 0910‑0014, and FDA Form 356h - OMB Control No. 0910‑0338.
In the guidance document, CDER and CBER ask that a request for formal dispute resolution be submitted as an amendment to the application for the underlying product and that it be submitted to the agency in triplicate with the appropriate form attached, either Form FDA 1571 or Form FDA 356h. The agency recommends that a request be submitted as an amendment in this manner for two reasons: To ensure that each request is kept in the administrative file with the entire underlying application and to ensure that pertinent information about the request is entered into the appropriate tracking databases. Use of the information in the agency's tracking databases enables the appropriate agency official to monitor progress on the resolution of the dispute and to ensure that appropriate steps will be taken in a timely manner.
CDER and CBER have determined and the guidance recommends that the following information should be submitted to the appropriate center with each request for dispute resolution so that the Center may quickly and efficiently respond to the request: (1) A brief but comprehensive statement of each issue to be resolved, including a description of the issue, the nature of the issue (i.e., scientific, procedural, or both), possible solutions based on information in the administrative file, whether informal dispute resolution was sought prior to the formal appeal, whether advisory committee review is sought, and the expected outcome; (2) a statement identifying the review division/office that issued the original decision on the matter and, if applicable, the last agency official that attempted to formally resolve the matter; (3) a list of documents in the administrative file, or additional copies of such documents, that are deemed necessary for resolution of the issue(s); and (4) a statement that the previous supervisory level has already had the opportunity to review all of the material relied on for dispute resolution. The information that the agency suggests submitting with a formal request for dispute resolution consists of: (1) Statements describing the issue from the perspective of the person with a dispute, (2) brief statements describing the history of the matter, and (3) the documents previously submitted to FDA under an OMB approved collection of information.
Purpose and Use of the Information Collection
The document is intended to provide guidance for industry on procedures that will be adopted by CDER and CBER for resolving scientific and procedural disputes that cannot be resolved at the division level. As explained above, CDER and CBER have determined that the information specified in the guidance should be submitted to the appropriate center with each request for dispute resolution so that the Center may quickly and efficiently respond to the request.
Use of Improved Information Technology and Burden Reduction
FDA has issued several guidances for industry to improve the use of information technology in the submission of marketing applications for human drugs and related reports. These guidance documents are available at FDA's web site http://www.fda.gov/cder/guidance/index.htm.
Efforts to Identify Duplication and Use of Similar Information
The information collection requested under the guidance does not duplicate any other information collection.
Impact on Small Businesses or Other Small Entities
Although new drug development is typically an activity completed by large multinational drug firms, the information collection requested under the guidance applies to small as well as large companies. Under the Regulatory Flexibility Act, FDA regularly analyzes regulatory options that would minimize any significant impact on small entities. FDA also assists small businesses in complying with regulatory requirements.
Consequences of Collecting the Information Less Frequently
As explained above, CDER and CBER have determined that the information specified in the guidance should be submitted to the appropriate center with each request for dispute resolution so that the Center may quickly and efficiently respond to the request.
Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60 day notice for public comment in the FEDERAL REGISTER of June 2, 2015 (80 FR 31386). FDA received no comments on the information collection.
Explanation of Any Payment or Gift to Respondents
FDA has not provided and has no intention to provide any payment or gift to respondents under this guidance.
Assurance of Confidentiality Provided to Respondents
Confidentiality of the information submitted under this guidance is protected under 21 CFR 314.430 and under 21 CFR part 20. The unauthorized use or disclosure of trade secrets required in applications is specifically prohibited under Section 310(j) of the Act.
Justification for Sensitive Questions
There are no questions of a sensitive nature.
Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
Based on FDA's experience with dispute resolution, the agency expects that most persons seeking formal dispute resolution will have gathered the materials listed previously when identifying the existence of a dispute with the agency. Consequently, FDA anticipates that the collection of information attributed solely to the guidance will be minimal.
Description of respondents: A sponsor, applicant, or manufacturer of a drug or biological product regulated by the agency under the act or section 351 of the Public Health Service Act who requests formal resolution of a scientific or procedural dispute.
Burden Estimate: Provided below is an estimate of the annual reporting burden for requests for dispute resolution. Based on data collected from review divisions and offices within CDER and CBER, FDA estimates that approximately 8 sponsors and applicants (respondents) submit requests for formal dispute resolution to CDER annually and approximately 1 respondent submits requests for formal dispute resolution to CBER annually. The total annual responses are the total number of requests submitted to CDER and CBER in 1 year, including requests for dispute resolution that a single respondent submits more than one time. FDA estimates that CDER receives approximately 31 requests annually and CBER receives approximately 1 request annually. The hours per response is the estimated number of hours that a respondent would spend preparing the information to be submitted with a request for formal dispute resolution in accordance with this guidance, including the time it takes to gather and copy brief statements describing the issue from the perspective of the person with the dispute, brief statements describing the history of the matter, and supporting information that has already been submitted to the agency. Based on experience, FDA estimates that approximately 8 hours on average would be needed per response. Therefore, FDA estimates that 8 hours will be spent per year by respondents requesting formal dispute resolution under the guidance.
Table 1.--Estimated Annual Reporting Burden
Requests for Formal Dispute Resolution |
Number of Respondents |
Number of Responses Per Respondent |
Total Annual Responses |
Average Burden Per Response |
Total Hours
|
CDER |
8 |
3.9 |
31 |
8 |
248 |
CBER |
1 |
1 |
1 |
8 |
8 |
Total |
256 |
||||
Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
FDA estimates an average industry wage rate of $80.00 per hour for preparing and submitting the information requested under the guidance. Multiplied times the total hour burden estimated above, the total cost burden to respondents is $20,480.
Annualized Cost to the Federal Government
FDA estimates that there will be no additional costs associated with the receipt/review by FDA of the information submitted under the guidance.
Explanation for Program Changes or Adjustments
We have adjusted the currently approved burden of 152 hours to 256 hours based on actual receipts over the past 3 years.
Plans for Tabulation and Publication and Project Time Schedule
There are no tabulated results to publish for this information collection.
Reason(s) Display of OMB Expiration Date is Inappropriate
The agency is not seeking to display the expiration date of OMB approval of the information collection.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.
| File Type | application/msword |
| Author | CDER USER |
| Last Modified By | Mizrachi, Ila |
| File Modified | 2015-10-21 |
| File Created | 2015-10-21 |