80 FR 60918 - Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; 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 195 (October 8, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 195 (October 8, 2015)
| Page Range | 60918-60920 | |
| FR Document | 2015-25623 |
[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)] [Notices] [Pages 60918-60920] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-25623] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0248] Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; 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 that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by November 9, 2015. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your [[Page 60919]] comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations .gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2012-N-0248 for ``Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0430. 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: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. 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 [[Page 60920]] 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 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. In the Federal Register of June 2, 2015 (80 FR 31386), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. 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 Requests for formal dispute resolution Number of responses per Total annual Average burden Total hours respondents respondent responses per 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: October 2, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-25623 Filed 10-7-15; 8:45 am] BILLING CODE 4164-01-P
![60918 Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices
made publicly available, submit your ‘‘Adverse Event Reporting for II. Paperwork Reduction Act
comments only as a written/paper Outsourcing Facilities Under Section This guidance contains collections of
submission. You should submit two 503B of the Federal Food, Drug, and information that are subject to review by
copies total. One copy will include the Cosmetic Act.’’ On November 27, 2013, the Office of Management and Budget
information you claim to be confidential President Obama signed the Drug under the Paperwork Reduction Act of
with a heading or cover note that states Quality and Security Act (DQSA) into 1995 (44 U.S.C. 3501–3520). The
‘‘THIS DOCUMENT CONTAINS law (Pub. L. 113–54). The DQSA added collections of information have been
CONFIDENTIAL INFORMATION’’. The a new section, 503B, to the FD&C Act approved under OMB control number
Agency will review this copy, including (21 U.S.C. 353b). Under section 503B(b), 0910–0800.
the claimed confidential information, in a compounder can register as an
its consideration of comments. The outsourcing facility with FDA. Section III. Electronic Access
second copy, which will have the 503B(d)(4) of the FD&C Act defines an Persons with access to the Internet
claimed confidential information outsourcing facility, in part, as a facility may obtain the guidance at either
redacted/blacked out, will be available that complies with all of the http://www.fda.gov/Drugs/
for public viewing and posted on requirements of section 503B, including GuidanceCompliance
http://www.regulations.gov. Submit registering with FDA as an outsourcing RegulatoryInformation/Guidances/
both copies to the Division of Dockets facility and paying associated fees. If the default.htm or http://
Management. If you do not wish your conditions outlined in section 503B(a) www.regulations.gov.
name and contact information to be of the FD&C Act are satisfied, a drug
Dated: October 2, 2015.
made publicly available, you can compounded by or under the direct
Leslie Kux,
provide this information on the cover supervision of a licensed pharmacist in
sheet and not in the body of your an outsourcing facility is exempt from Associate Commissioner for Policy.
comments and you must identify this certain sections of the FD&C Act, [FR Doc. 2015–25622 Filed 10–7–15; 8:45 am]
information as ‘‘confidential.’’ Any including section 502(f)(1) (21 U.S.C. BILLING CODE 4164–01–P
information marked as ‘‘confidential’’ 352(f)(1)) (concerning the labeling of
will not be disclosed except in drugs with adequate directions for use)
accordance with 21 CFR 10.20 and other and section 505 (21 U.S.C. 355) DEPARTMENT OF HEALTH AND
applicable disclosure law. For more (concerning the approval of human drug HUMAN SERVICES
information about FDA’s posting of products under new drug applications
Food and Drug Administration
comments to public dockets, see 80 FR (NDAs) or abbreviated new drug
56469, September 18, 2015, or access applications (ANDAs)). Drugs [Docket No. FDA–2012–N–0248]
the information at: http://www.fda.gov/ compounded in outsourcing facilities
regulatoryinformation/dockets/ are not exempt from the requirements of Agency Information Collection
default.htm. section 501(a)(2)(B) of the FD&C Act (21 Activities; Proposed Collection;
Docket: For access to the docket to U.S.C. 351(a)(2)(B)) (concerning current Submission for Office of Management
read background documents or the good manufacturing practice for drugs). and Budget Review; Guidance for
electronic and written/paper comments Industry on Formal Dispute
Under section 503B(b)(5), an
received, go to http:// Resolution; Appeals Above the
outsourcing facility must submit
www.regulations.gov and insert the Division Level
adverse event reports to FDA in
docket number, found in brackets in the accordance with the content and format AGENCY: Food and Drug Administration,
heading of this document, into the requirements established through HHS.
‘‘Search’’ box and follow the prompts guidance or regulation under 21 CFR ACTION: Notice.
and/or go to the Division of Dockets 310.305 (or any successor regulations).
Management, 5630 Fishers Lane, Rm. This guidance explains how FDA SUMMARY: The Food and Drug
1061, Rockville, MD 20852. intends to implement § 310.305 with Administration (FDA) is announcing
Submit written requests for single respect to outsourcing facilities. that a proposed collection of
copies of the guidance to the Division of information has been submitted to the
Drug Information, Center for Drug In the Federal Register of February
Office of Management and Budget
Evaluation and Research, Food and 19, 2015 (80 FR 8872), FDA issued a
(OMB) for review and clearance under
Drug Administration, 10001 New notice announcing the availability of the
the Paperwork Reduction Act of 1995.
Hampshire Ave., Hillandale Building, draft version of this guidance. The
comment period on the draft guidance DATES: Fax written comments on the
4th Floor, Silver Spring, MD 20993. collection of information by November
Send one self-addressed adhesive label ended on May 20, 2015. FDA received
seven comments on the draft guidance. 9, 2015.
to assist that office in processing your ADDRESSES: You may submit comments
requests. See the SUPPLEMENTARY In response to received comments or
as follows:
INFORMATION section for electronic on its own initiative, FDA made several
access to the guidance document. changes to clarify particular points and Electronic Submissions
FOR FURTHER INFORMATION CONTACT: Sara to provide updated information. Submit electronic comments in the
Rothman, Office of Compliance, Center This guidance is being issued following way:
for Drug Evaluation and Research, Food consistent with FDA’s good guidance • Federal eRulemaking Portal: http://
and Drug Administration, 10903 New
mstockstill on DSK4VPTVN1PROD with NOTICES
practices regulation (21 CFR 10.115). www.regulations.gov. Follow the
Hampshire Ave., Silver Spring, MD The guidance represents FDA’s current instructions for submitting comments.
20993–0002, 301–796–3110. thinking on this topic. It does not create Comments submitted electronically,
SUPPLEMENTARY INFORMATION: any rights for any person and is not including attachments, to http://
binding on FDA or the public. An www.regulations.gov will be posted to
I. Background alternative approach can be used if such the docket unchanged. Because your
FDA is announcing the availability of approach satisfies the requirements of comment will be made public, you are
a final guidance for industry entitled the applicable statutes and regulations. solely responsible for ensuring that your
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![60920 Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices
an appropriate cover form. Form FDA whether informal dispute resolution In the Federal Register of June 2, 2015
1571 must accompany submissions was sought prior to the formal appeal, (80 FR 31386), FDA published a 60-day
under INDs and Form FDA 356h must whether advisory committee review is notice requesting public comment on
accompany submissions under NDAs, sought, and the expected outcome; (2) a the proposed collection of information.
ANDAs, and BLAs. Both forms have statement identifying the review No comments were received.
valid OMB control numbers as follows: division/office that issued the original Burden Estimate: Provided in this
FDA Form 1571—OMB control number decision on the matter and, if document is an estimate of the annual
0910–0014, and FDA Form 356h—OMB applicable, the last Agency official that reporting burden for requests for dispute
control number 0910–0338. attempted to formally resolve the resolution. Based on data collected from
In the guidance document, CDER and matter; (3) a list of documents in the review divisions and offices within
CBER ask that a request for formal administrative file, or additional copies CDER and CBER, FDA estimates that
dispute resolution be submitted as an of such documents, that are deemed approximately eight sponsors and
amendment to the application for the necessary for resolution of the issue(s); applicants (respondents) submit
underlying product and that it be and (4) a statement that the previous requests for formal dispute resolution to
submitted to the Agency in triplicate supervisory level has already had the CDER annually and approximately one
with the appropriate form attached, opportunity to review all of the material respondent submits requests for formal
either Form FDA 1571 or Form FDA relied on for dispute resolution. The dispute resolution to CBER annually.
356h. The Agency recommends that a information that the Agency suggests The total annual responses are the total
request be submitted as an amendment submitting with a formal request for number of requests submitted to CDER
in this manner for two reasons: To dispute resolution consists of: (1) and CBER in 1 year, including requests
ensure that each request is kept in the Statements describing the issue from the for dispute resolution that a single
administrative file with the entire perspective of the person with a respondent submits more than one time.
underlying application and to ensure dispute, (2) brief statements describing FDA estimates that CDER receives
that pertinent information about the the history of the matter, and (3) the approximately 31 requests annually and
request is entered into the appropriate documents previously submitted to FDA CBER receives approximately 1 request
tracking databases. Use of the under an OMB approved collection of annually. The hours per response is the
information in the Agency’s tracking information. estimated number of hours that a
databases enables the appropriate Based on FDA’s experience with respondent would spend preparing the
Agency official to monitor progress on dispute resolution, the Agency expects information to be submitted with a
the resolution of the dispute and to that most persons seeking formal request for formal dispute resolution in
ensure that appropriate steps will be dispute resolution will have gathered accordance with this guidance,
taken in a timely manner. the materials listed previously when including the time it takes to gather and
CDER and CBER have determined and identifying the existence of a dispute copy brief statements describing the
the guidance recommends that the with the Agency. Consequently, FDA issue from the perspective of the person
following information should be anticipates that the collection of with the dispute, brief statements
submitted to the appropriate center with information attributed solely to the describing the history of the matter, and
each request for dispute resolution so guidance will be minimal. supporting information that has already
that the Center may quickly and Description of Respondents: A been submitted to the Agency. Based on
efficiently respond to the request: (1) A sponsor, applicant, or manufacturer of a experience, FDA estimates that
brief but comprehensive statement of drug or biological product regulated by approximately 8 hours on average
each issue to be resolved, including a the Agency under the Federal Food, would be needed per response.
description of the issue, the nature of Drug, and Cosmetic Act or section 351 Therefore, FDA estimates that 8 hours
the issue (i.e., scientific, procedural, or of the Public Health Service Act who will be spent per year by respondents
both), possible solutions based on requests formal resolution of a scientific requesting formal dispute resolution
information in the administrative file, or procedural dispute. 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: October 2, 2015. DEPARTMENT OF HEALTH AND amended (5 U.S.C. App.), notice is
Leslie Kux, HUMAN SERVICES hereby given of the following meetings.
mstockstill on DSK4VPTVN1PROD with NOTICES
Associate Commissioner for Policy. The meetings will be closed to the
[FR Doc. 2015–25623 Filed 10–7–15; 8:45 am] National Institutes of Health public in accordance with the
BILLING CODE 4164–01–P provisions set forth in sections
National Heart, Lung, and Blood 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
Institute Notice of Closed Meetings as amended. The grant applications and
the discussions could disclose
Pursuant to section 10(d) of the
confidential trade secrets or commercial
Federal Advisory Committee Act, as property such as patentable material,
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Document Created: 2015-12-15 08:43:13
Document Modified: 2015-12-15 08:43:13
| 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 | Fax written comments on the collection of information by November 9, 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 60918 |
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