83 FR 48435 - Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications; Draft Guidance for Industry and Review Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 186 (September 25, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 186 (September 25, 2018)
| Page Range | 48435-48437 | |
| FR Document | 2018-20789 |
[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)] [Notices] [Pages 48435-48437] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20789] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-3103] Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications; Draft Guidance for Industry and Review Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and review staff entitled ``Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications.'' This draft guidance describes the fundamental values and [[Page 48436]] operational principles that serve as the foundation for the review process. It also clarifies the roles and responsibilities of review staff and identifies ways in which applicants may support a robust and efficient review process. This draft guidance revises the guidance for review staff and industry entitled ``Good Review Management Principles and Practices for PDUFA Products'' issued April 2005. DATES: Submit either electronic or written comments on the draft guidance by December 24, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2018-D-3103 for ``Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Pinakini Patel, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6367, Silver Spring, MD 20993-0002, 301- 796-7475; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry and review staff entitled ``Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications.'' This draft guidance describes good review management principles and practices (GRMPs) for the review of a new drug application (NDA), biologics license application (BLA), or an efficacy supplement/supplement with clinical data. This guidance applies to human drug applications (as defined in section 735(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379g(1))) and biosimilar biological product applications (section 744G(4) of the FD&C Act (21 U.S.C. 379j-51(4))). This guidance also discusses the roles and responsibilities of review staff in managing the review process and identifies ways in which applicants may support an efficient and robust review process. This draft guidance revises the guidance for review staff and industry entitled ``Good Review Management Principles and Practices for PDUFA Products'' issued in April 2005. FDA committed to updating the 2005 guidance as part of the Prescription Drug User Fee Act (PDUFA) VI and Biosimilar User Fee Act (BsUFA) II. This draft guidance meets that commitment by reflecting advances in the PDUFA program and implementation of BsUFA. This draft guidance also reflects the evolution of GRMPs to support new regulatory programs such as breakthrough therapy, the Program for Enhanced Review [[Page 48437]] Transparency and Communication for NME (New Molecular Entity) NDAs and Original BLAs, and risk evaluation and mitigation strategies. In addition, the draft guidance has been consolidated to focus on the fundamental values and operational principles that serve as the foundation for the GRMPs. Details of the review process are covered in other documents referenced by this guidance. Fundamental values and operational principles should remain relatively constant over time, while processes must be able to adapt and respond to scientific advances in product development and evolving public health needs. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on GRMPs for NDAs and BLAs. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. Electronic Access Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov. Dated: September 19, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-20789 Filed 9-24-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices 48435
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 U.S.C. section responses per burden per Total hours
respondents responses
respondent response
21 U.S.C. 379aa–1(b)(1)—serious adverse event reports
for dietary supplements .................................................... 230 12 2,760 2 5,520
21 U.S.C. 379aa–1(c)(2)—followup reports of new medical
information ........................................................................ 58 12 696 1 696
Total .............................................................................. ........................ ........................ ........................ ........................ 6,216
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the be 230. Finally, we estimate that it will We estimate that around 25 percent of
information collection reflects an take respondents an average of 2 hours serious adverse event reports related to
annual decrease of 219 hours for per report to collect information about dietary supplements will have a
reporting. We attribute this adjustment a serious adverse event associated with followup report submitted, resulting in
to a decrease in the number of reports a dietary supplement and report the approximately 696 followup reports
we received over the last few years. information to us on Form FDA 3500A. submitted annually. Dividing the annual
This estimate is based on our Thus, the estimated burden associated number of reports among the 230 firms
experience with similar adverse event with submitting initial dietary reporting results in approximately 12
reporting programs and the number of supplement serious adverse event reports for 58 respondents. We estimate
serious adverse event reports and reports is 5,520 hours (2,760 responses
that each followup report will require
followup reports received in the past 3 × 2 hours) as shown in row 1 of
an hour to assemble and submit,
years. All dietary supplement table 1.
If a respondent that has submitted a including the time needed to copy and
manufacturers, packers, or distributors
are subject to serious adverse event serious adverse event report receives attach the initial serious adverse event
mandatory reporting. new information related to the serious report as recommended in the guidance.
In the past 3 years, we received an adverse event within 1 year of Thus, the estimated burden for followup
average of 2,760 initial serious adverse submitting the initial report, the reports of new information is 696 hours
event reports. We also estimated an respondent must provide the new (696 responses × 1 hour) as shown in
average number of firms filing reports to information to us in a followup report. row 2 of table 1.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
Number of Total annual Average burden per
21 U.S.C. section records per Total hours
recordkeepers records recordkeeping
recordkeeper
21 U.S.C. 379aa–1(e)(1))—dietary supplement ad- 1,815 72 130,680 0.5 (30 minutes) ........ 65,340
verse events records.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the assembled and filed in accordance with DEPARTMENT OF HEALTH AND
information collection reflects an the safety reporting portal, we expect HUMAN SERVICES
annual increase of 2,440 hours for the records retention burden to be
recordkeeping. We attribute this minimal, as we believe most Food and Drug Administration
adjustment to an increase in the number establishments would normally keep [Docket No. FDA–2018–D–3103]
of reports we received over the last few this kind of record for at least several
years. years after receiving the report, as a Good Review Management Principles
All dietary supplement matter of usual and customary business and Practices for New Drug
manufacturers, packers, or distributors practice. Applications and Biologics License
are subject to serious adverse event Applications; Draft Guidance for
Dated: September 19, 2018. Industry and Review Staff; Availability
recordkeeping. We estimate that there
are 1,815 such respondents. Estimating Leslie Kux,
AGENCY: Food and Drug Administration,
that each recordkeeper will keep Associate Commissioner for Policy.
HHS.
approximately 72 records per year [FR Doc. 2018–20766 Filed 9–24–18; 8:45 am]
results in an annual burden of 130,680 ACTION: Notice of availability.
BILLING CODE 4164–01–P
records. Estimating that assembling and SUMMARY: The Food and Drug
filing these records, including any Administration (FDA or Agency) is
daltland on DSKBBV9HB2PROD with NOTICES
necessary photocopying, will take announcing the availability of a draft
approximately 30 minutes, or 0.5 hour, guidance for industry and review staff
per record, results in an annual burden entitled ‘‘Good Review Management
of 65,340 hours (130,680 records × 0.5 Principles and Practices for New Drug
hour). Applications and Biologics License
Once the documents pertaining to an Applications.’’ This draft guidance
adverse event report have been describes the fundamental values and
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![Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices 48437
Transparency and Communication for Act), as amended by the Food and Drug 6 months after the receipt or filing date,
NME (New Molecular Entity) NDAs and Administration Amendments Act of depending upon the type of application.
Original BLAs, and risk evaluation and 2007 (FDAAA), authorizes FDA to Information regarding the PDUFA goals
mitigation strategies. determine and collect priority review is available at: https://www.fda.gov/
In addition, the draft guidance has user fees for certain applications for downloads/forindustry/userfees/
been consolidated to focus on the review of drug or biological products prescriptiondruguserfee/
fundamental values and operational when those applications use a tropical ucm511438.pdf.
principles that serve as the foundation disease priority review voucher. These The applicant that uses a priority
for the GRMPs. Details of the review vouchers are awarded to the applicants review voucher is entitled to a priority
process are covered in other documents of certain tropical disease product review but must pay FDA a priority
referenced by this guidance. applications, submitted after September review user fee in addition to any other
Fundamental values and operational 27, 2007, upon FDA approval of such fee required by PDUFA. FDA published
principles should remain relatively applications. The amount of the fee guidance on its website about how this
constant over time, while processes submitted to FDA with applications tropical disease priority review voucher
must be able to adapt and respond to using a tropical disease priority review program operates (available at: https://
scientific advances in product voucher is determined each fiscal year www.fda.gov/downloads/Drugs/
development and evolving public health based on the difference between the GuidanceComplianceRegulatory
needs. average cost incurred by FDA to review Information/Guidances/
This draft guidance is being issued a human drug application designated as ucm080599.pdf).
consistent with FDA’s good guidance priority review in the previous fiscal This notice establishes the tropical
practices regulation (21 CFR 10.115). year and the average cost incurred in the disease priority review fee rate for FY
The draft guidance, when finalized, will review of an application that is not 2019 as $2,457,140 and outlines FDA’s
represent the current thinking of FDA subject to priority review in the process for implementing the collection
on GRMPs for NDAs and BLAs. It does previous fiscal year. This notice of the priority review user fees. This rate
not establish any rights for any person establishes the tropical disease priority is effective on October 1, 2018, and will
and is not binding on FDA or the public. review fee rate for FY 2019. remain in effect through September 30,
You can use an alternative approach if 2019, for applications submitted with a
FOR FURTHER INFORMATION CONTACT:
it satisfies the requirements of the tropical disease priority review voucher.
Lola Olajide, Office of Financial The payment of this priority review user
applicable statutes and regulations. This Management, Food and Drug
guidance is not subject to Executive fee is required in addition to the
Administration, 8455 Colesville Rd., payment of any other fee that would
Order 12866. COLE–14541B, Silver Spring, MD normally apply to such an application
II. Electronic Access 20993–0002, 240–402–4244. under PDUFA before FDA will consider
Persons with access to the internet SUPPLEMENTARY INFORMATION: the application complete and acceptable
may obtain the draft guidance at https:// I. Background for filing.
www.fda.gov/Drugs/Guidance
Section 1102 of FDAAA (Pub. L. 110– II. Tropical Disease Priority Review
ComplianceRegulatoryInformation/
85) added section 524 to the FD&C Act User Fee for FY 2019
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/ (21 U.S.C. 360n). In section 524, FDA interprets section 524(c)(2) of the
GuidanceComplianceRegulatory Congress encouraged development of FD&C Act as requiring that FDA
Information/default.htm, or https:// new drug and biological products for determine the amount of the tropical
www.regulations.gov. prevention and treatment of tropical disease priority review user fee each
diseases by offering additional fiscal year based on the difference
Dated: September 19, 2018.
incentives for obtaining FDA approval between the average cost incurred by
Leslie Kux, of such products. Under section 524, the FDA in the review of a human drug
Associate Commissioner for Policy. applicant of an eligible human drug application subject to priority review in
[FR Doc. 2018–20789 Filed 9–24–18; 8:45 am] application submitted after September the previous fiscal year and the average
BILLING CODE 4164–01–P 27, 2007, for a tropical disease (as cost incurred by FDA in the review of
defined in section 524(a)(3) of the FD&C a human drug application that is not
Act) shall receive a priority review subject to priority review in the
DEPARTMENT OF HEALTH AND voucher upon approval of the tropical previous fiscal year.
HUMAN SERVICES disease product application (assuming A priority review is a review
other criteria are met). The recipient of conducted with a PDUFA goal date of 6
Food and Drug Administration
a tropical disease priority review months after the receipt or filing date,
[Docket No. FDA–2018–N–0007] voucher may either use the voucher depending on the type of application.
with a future submission to FDA under Under the PDUFA goals letter, FDA has
Fee for Using a Tropical Disease section 505(b)(1) of the FD&C Act (21 committed to reviewing and acting on
Priority Review Voucher in Fiscal Year U.S.C. 355(b)(1)) or section 351(a) of the 90 percent of the applications granted
2019 Public Health Service Act (42 U.S.C. priority review status within this
AGENCY: Food and Drug Administration, 262), or transfer (including by sale) the expedited timeframe. Normally, an
HHS. voucher to another party. The voucher application for a human drug or
ACTION: Notice. may be transferred (including by sale) biological product will qualify for
daltland on DSKBBV9HB2PROD with NOTICES
repeatedly until it ultimately is used for priority review if the product is
SUMMARY: The Food and Drug a human drug application submitted to intended to treat a serious condition
Administration (FDA or the Agency) is FDA under section 505(b)(1) of the and, if approved, would provide a
announcing the fee rates for using a FD&C Act or section 351(a) of the Public significant improvement in safety or
tropical disease priority review voucher Health Service Act. A priority review is effectiveness. An application that does
for fiscal year (FY) 2019. The Federal a review conducted with a Prescription not receive a priority designation
Food, Drug, and Cosmetic Act (FD&C Drug User Fee Act (PDUFA) goal date of receives a standard review. Under the
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Document Created: 2018-09-25 00:21:46
Document Modified: 2018-09-25 00:21:46
| 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 of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by December 24, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Pinakini Patel, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6367, Silver Spring, MD 20993-0002, 301- 796-7475; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 83 FR 48435 |
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