80 FR 31386 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 105 (June 2, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 105 (June 2, 2015)
| Page Range | 31386-31388 | |
| FR Document | 2015-13386 |
[Federal Register Volume 80, Number 105 (Tuesday, June 2, 2015)] [Notices] [Pages 31386-31388] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-13386] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0248] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in the guidance for industry on formal dispute resolution. DATES: Submit either electronic or written comments on the collection of information by August 3, 2015. ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. [[Page 31387]] ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level (OMB Control Number 0910-0430)--Extension This information collection approval request is for 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 (Sec. 10.75 (21 CFR 10.75)) and dispute resolution during the investigational new drug (IND) process (Sec. 312.48 (21 CFR 312.48)) and the new drug application/abbreviated new drug application (NDA/ANDA) process (Sec. 314.103 (21 CFR 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 (Sec. 10.75(d)). In general, the information in an administrative file is collected under existing regulations in part 312 (OMB control number 0910-0014), part 314 (OMB control number 0910-0001), and part 601 (21 CFR part 601) (OMB control number 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 (Sec. Sec. 312.23(a)(11) and (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 number 0910-0014, and FDA Form 356h--OMB control number 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. 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 [[Page 31388]] the Agency under the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act who requests formal resolution of a scientific or procedural dispute. Burden Estimate: Provided in this document 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 eight sponsors and applicants (respondents) submit requests for formal dispute resolution to CDER annually and approximately one 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 \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average Requests for formal dispute Number of responses per Total annual burden per Total hours resolution respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- CDER............................ 8 2 31 8 248 CBER............................ 1 1 1 8 8 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 256 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: May 27, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-13386 Filed 6-1-15; 8:45 am] BILLING CODE 4164-01-P
![31386 Federal Register / Vol. 80, No. 105 / Tuesday, June 2, 2015 / Notices
• facilitate, identify, and prioritize • Step 6: Register With Electronic Dated: May 28, 2015.
technical assistance and development Research Administration (eRA) Leslie Kux,
needs, develop strategic and project Commons Associate Commissioner for Policy.
plans, and allocate resources to Steps 1 through 5, in detail, can be [FR Doc. 2015–13337 Filed 6–1–15; 8:45 am]
coordinate FDA training program found at http://www07.grants.gov/ BILLING CODE 4164–01–P
components for U.S. teachers actively applicants/organization_
incorporating FDA’s food safety and registration.jsp. Step 6, in detail, can be
nutrition curriculum in their found at https://commons.era.nih.gov/ DEPARTMENT OF HEALTH AND
classrooms, as specified in the various commons/registration/ HUMAN SERVICES
training components of this proposed registrationInstructions.jsp. After you
cooperative agreement. have followed these steps, submit Food and Drug Administration
C. Eligibility Information electronic applications to: http:// [Docket No. FDA–2012–N–0248]
www.grants.gov.
The following organization is eligible Agency Information Collection
to apply: Graduate School USA. Dated: May 28, 2015.
Activities; Proposed Collection;
Leslie Kux,
II. Award Information/Funds Available Comment Request; Guidance for
Associate Commissioner for Policy.
Industry on Formal Dispute
A. Award Amount [FR Doc. 2015–13330 Filed 6–1–15; 8:45 am] Resolution; Appeals Above the
BILLING CODE 4164–01–P Division Level
The number of awards is contingent
upon FDA appropriations and the AGENCY: Food and Drug Administration,
submission of a sufficient number of HHS.
DEPARTMENT OF HEALTH AND
meritorious applications. Future year
HUMAN SERVICES ACTION: Notice.
amounts will depend on annual
appropriations, availability of funding Food and Drug Administration SUMMARY: The Food and Drug
and awardee performance. Administration (FDA) is announcing an
FDA/CFSAN intends to fund up to [Docket No. FDA–2015–N–1805]
opportunity for public comment on the
$452,700.00 for fiscal year 2015 in proposed collection of certain
Retrospective Review of Premarket
support of this grant program. information by the Agency. Under the
Approval Application Devices; Striking
Application budgets need to reflect the Paperwork Reduction Act of 1995 (the
the Balance Between Premarket and
actual needs of the proposed project and PRA), Federal Agencies are required to
Postmarket Data Collection; Correction
should not exceed the following in total publish notice in the Federal Register
costs (direct and indirect): AGENCY: Food and Drug Administration, concerning each proposed collection of
YR 1: $452,700 HHS. information, including each proposed
YR 2: $500,000 ACTION: Notice; request for comments; extension of an existing collection of
YR 3: $500,000 correction. information, and to allow 60 days for
YR 4: $500,000 public comment in response to the
YR 5: $500,000 SUMMARY: The Food and Drug notice. This notice solicits comments on
Administration is correcting a notice the information collection contained in
B. Length of Support entitled ‘‘Retrospective Review of the guidance for industry on formal
The scope of the proposed project Premarket Approval Application dispute resolution.
should determine the project period. Devices; Striking the Balance Between
DATES: Submit either electronic or
The maximum project period is 5 years. Premarket and Postmarket Data
Collection’’ that appeared in the Federal written comments on the collection of
III. Electronic Application, Register of April 29, 2015 (80 FR information by August 3, 2015.
Registration, and Submission 23798). The document announced the ADDRESSES: Submit electronic
Only electronic applications will be progress of the Center for Devices and comments on the collection of
accepted. To submit an electronic Radiological Health on its 2014–2015 information to http://
application in response to this FOA, Strategic Priority ‘‘Strike the Right www.regulations.gov. Submit written
applicants should first review the full Balance Between Premarket and comments on the collection of
announcement located at http:// Postmarket Data Collection.’’ The information to the Division of Dockets
www.grants.gov. Search by Funding document was published with the Management (HFA–305), Food and Drug
Opportunity Number: RFA–FD–15–011. incorrect docket number. This Administration, 5630 Fishers Lane, Rm.
(FDA has verified the Web site document corrects that error. 1061, Rockville, MD 20852. All
addresses throughout this document, FOR FURTHER INFORMATION CONTACT: Lisa
comments should be identified with the
but FDA is not responsible for any Granger, Office of Policy and Planning, docket number found in brackets in the
subsequent changes to the Web sites Food and Drug Administration, 10903 heading of this document.
after this document publishes in the New Hampshire Ave., Bldg. 32, Rm. FOR FURTHER INFORMATION CONTACT: FDA
Federal Register.) For all electronically 3330, Silver Spring, MD 20993–0002, PRA Staff, Office of Operations, Food
submitted applications, the following 301–796–9115. and Drug Administration, 8455
steps are required. SUPPLEMENTARY INFORMATION: In the
Colesville Rd., COLE–14526, Silver
asabaliauskas on DSK5VPTVN1PROD with NOTICES
• Step 1: Obtain a Dun and Bradstreet Federal Register of April 29, 2015, in Spring, MD 20993–0002, PRAStaff@
(DUNS) Number FR Doc. 2015–09884, on page 23798, the fda.hhs.gov.
• Step 2: Register With System for following correction is made: SUPPLEMENTARY INFORMATION: Under the
Award Management (SAM) 1. On page 23798, in the first column, PRA (44 U.S.C. 3501–3520), Federal
• Step 3: Obtain Username & Password in the headings section of the document, Agencies must obtain approval from the
• Step 4: Authorized Organization ‘‘[Docket No. FDA–2014–D–0090]’’ is Office of Management and Budget
Representative (AOR) Authorization corrected to read ‘‘[Docket No. FDA– (OMB) for each collection of
• Step 5: Track AOR Status 2015–N–1805]’’. information they conduct or sponsor.
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![31388 Federal Register / Vol. 80, No. 105 / Tuesday, June 2, 2015 / Notices
the Agency under the Federal Food, respondent submits requests for formal accordance with this guidance,
Drug, and Cosmetic Act or section 351 dispute resolution to CBER annually. including the time it takes to gather and
of the Public Health Service Act who The total annual responses are the total copy brief statements describing the
requests formal resolution of a scientific number of requests submitted to CDER issue from the perspective of the person
or procedural dispute. and CBER in 1 year, including requests with the dispute, brief statements
Burden Estimate: Provided in this for dispute resolution that a single describing the history of the matter, and
document is an estimate of the annual respondent submits more than one time. supporting information that has already
reporting burden for requests for dispute FDA estimates that CDER receives been submitted to the Agency. Based on
resolution. Based on data collected from approximately 31 requests annually and experience, FDA estimates that
review divisions and offices within CBER receives approximately 1 request approximately 8 hours on average
CDER and CBER, FDA estimates that annually. The hours per response is the would be needed per response.
approximately eight sponsors and estimated number of hours that a Therefore, FDA estimates that 8 hours
applicants (respondents) submit respondent would spend preparing the will be spent per year by respondents
requests for formal dispute resolution to information to be submitted with a requesting formal dispute resolution
CDER annually and approximately one request for formal dispute resolution in under the guidance.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Requests for formal dispute resolution responses per burden per Total hours
respondents responses
respondent response
CDER ................................................................................... 8 2 31 8 248
CBER ................................................................................... 1 1 1 8 8
Total .............................................................................. ........................ ........................ ........................ ........................ 256
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 27, 2015. DATES: Submit either electronic or before submitting the collection to OMB
Leslie Kux, written comments on the collection of for approval. To comply with this
Associate Commissioner for Policy. information by August 3, 2015. requirement, FDA is publishing notice
[FR Doc. 2015–13386 Filed 6–1–15; 8:45 am] ADDRESSES: Submit electronic of the proposed collection of
BILLING CODE 4164–01–P comments on the collection of information set forth in this document.
information to http:// With respect to the following
www.regulations.gov. Submit written collection of information, FDA invites
DEPARTMENT OF HEALTH AND comments on the collection of comments on these topics: (1) Whether
HUMAN SERVICES information to the Division of Dockets the proposed collection of information
Management (HFA–305), Food and Drug is necessary for the proper performance
Food and Drug Administration Administration, 5630 Fishers Lane, Rm. of FDA’s functions, including whether
1061, Rockville, MD 20852. All the information will have practical
[Docket No. FDA–2012–N–0748] comments should be identified with the utility; (2) the accuracy of FDA’s
docket number found in brackets in the estimate of the burden of the proposed
Agency Information Collection heading of this document. collection of information, including the
Activities; Proposed Collection; FOR FURTHER INFORMATION CONTACT: FDA validity of the methodology and
Comment Request; Guidance for PRA Staff, Office of Operations, Food assumptions used; (3) ways to enhance
Industry on Generic Drug User Fee and Drug Administration, 8455 the quality, utility, and clarity of the
Cover Sheet; Form FDA 3794 Colesville Rd., COLE–14526, Silver information to be collected; and (4)
AGENCY: Food and Drug Administration, Spring, MD 20993–0002, PRAStaff@ ways to minimize the burden of the
HHS. fda.hhs.gov. collection of information on
SUPPLEMENTARY INFORMATION: Under the
respondents, including through the use
ACTION: Notice. of automated collection techniques,
PRA, (44 U.S.C. 3501–3520), Federal
SUMMARY: The Food and Drug Agencies must obtain approval from the when appropriate, and other forms of
Administration (FDA) is announcing an Office of Management and Budget information technology.
opportunity for public comment on the (OMB) for each collection of Generic Drug User Fee Cover Sheet;
proposed collection of certain information they conduct or sponsor. Form FDA 3794
information by the Agency. Under the ‘‘Collection of information’’ is defined
Paperwork Reduction Act of 1995 (the in 44 U.S.C. 3502(3) and 5 CFR OMB Control Number 0910–0727—
PRA), Federal Agencies are required to 1320.3(c) and includes Agency requests Extension
publish notice in the Federal Register or requirements that members of the On July 9, 2012, the Generic Drug
concerning each proposed collection of public submit reports, keep records, or User Fee Act (GDUFA) (Pub. L. 112–
asabaliauskas on DSK5VPTVN1PROD with NOTICES
information, including each proposed provide information to a third party. 144, Title 111) was signed into law by
extension of an existing collection of Section 3506(c)(2)(A) of the PRA (44 the President. GDUFA, designed to
information, and to allow 60 days for U.S.C. 3506(c)(2)(A)) requires Federal speed the delivery of safe and effective
public comment in response to the Agencies to provide a 60-day notice in generic drugs to the public and reduce
notice. This notice solicits comments the Federal Register concerning each costs to industry, requires that generic
concerning collection of information proposed collection of information, drug manufacturers pay user fees to
using Form FDA 3794 entitled ‘‘Generic including each proposed extension of an finance critical and measurable program
Drug User Fee Cover Sheet.’’ existing collection of information, enhancements. The user fees required
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Document Created: 2015-12-15 15:12:41
Document Modified: 2015-12-15 15:12:41
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by August 3, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 31386 |
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