81 FR 73115 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 205 (October 24, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 205 (October 24, 2016)
| Page Range | 73115-73116 | |
| FR Document | 2016-25606 |
[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)] [Notices] [Pages 73115-73116] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-25606] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0663] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) 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 (the PRA). DATES: Fax written comments on the collection of information by November 23, 2016. ADDRESSES: 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 0910-0672. Also include the FDA docket number found in brackets in the heading of this document. Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans; OMB Control Number 0910-0672--Extension In the Federal Register of October 31, 2013 (78 FR 65338), FDA published a document entitled ``Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans.'' The document clarified the Agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implemented internationally harmonized definitions and reporting standards for IND safety reports. The document also required safety reporting for bioavailability and bioequivalence studies. The document was intended to improve the utility of Investigational New Drug (IND) safety reports, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, and harmonize safety reporting requirements internationally. The rulemaking included the following information collection under the PRA that was not already included in 21 CFR 312.32 and approved under OMB control number 0910-0014. Section 312.32(c)(1)(ii) and (c)(1)(iii) requires reporting to FDA, in an IND safety report, of potential serious risks from clinical trials within 15 calendar days for findings from epidemiological studies, pooled analyses of multiple studies, or other clinical studies that suggest a significant risk in humans exposed to the drug. Section 312.32(c)(1)(iii) specifies the requirements for reporting to FDA in an IND safety report potential serious risks from clinical trials within 15 calendar days for findings from in vitro testing that suggest a significant risk to humans. Section 312.32(c)(1)(iv) requires reporting to FDA in an IND safety report within 15 calendar days of any clinically important increase in the rate of occurrence of serious suspected adverse reactions over that listed in the protocol or investigator brochure. The rulemaking also included new information collection under the PRA by requiring safety reporting for bioavailability and bioequivalence studies (21 CFR 320.31(d)). In tables 1 and 2 of this document, the estimates for ``No. of Respondents,'' ``No. of Responses per Respondent,'' and ``Total Annual Responses'' were obtained from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) reports and data management systems for submissions received in 2013, 2014, and 2015, and from other sources familiar with the number of submissions received under the noted 21 CFR section. The estimates the ``Hours per Response'' are unchanged based on information from CDER and CBER individuals familiar with the burden associated with these reports and from prior estimates received from the pharmaceutical industry. In the Federal Register of March 18, 2016 (81 FR 14860), we published a 60-day notice requesting public comment on the proposed extension of this [[Page 73116]] collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden [CDER] \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average 21 CFR section Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- 320.31(d) Bioavailability and 13 15 195 14 2,730 Bioequivalence Safety Reports.. 312.32(c)(1)(ii) and (c)(1)(iii) 100 6 600 12 7,200 IND Safety Reports............. 312.32(c)(1)(iv) IND Safety 10 1 10 12 120 Reports........................ ------------------------------------------------------------------------------- Total (CDER)................ .............. .............. .............. .............. 10,050 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Annual Reporting Burden [CBER] \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average 21 CFR section Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- 320.31(d) Bioavailability and 1 1 1 14 14 Bioequivalence Safety Reports.. 312.32(c)(1)(ii) and (c)(1)(iii) 137 4 548 12 6,576 IND Safety Reports............. 312.32(c)(1)(iv) IND Safety 5 1.4 7 12 84 Reports........................ ------------------------------------------------------------------------------- Total (CBER)................ .............. .............. .............. .............. 6,674 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 18, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-25606 Filed 10-21-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Notices 73115
B. Candidate Prioritization DEPARTMENT OF HEALTH AND reports. The document also required
HUMAN SERVICES safety reporting for bioavailability and
The Agencies intend to review bioequivalence studies. The document
Parallel Review requests and respond Food and Drug Administration was intended to improve the utility of
within 30 days after receipt of the email. Investigational New Drug (IND) safety
[Docket No. FDA–2013–N–0663]
The Agencies intend to prioritize reports, expedite FDA’s review of
innovative medical devices that will Agency Information Collection critical safety information, better protect
benefit from the efficiencies of the Activities; Submission for Office of human subjects enrolled in clinical
Parallel Review. Priority will also be Management and Budget Review; trials, and harmonize safety reporting
given to medical devices expected to Comment Request; Investigational requirements internationally.
have the most impact on the Medicare New Drug Safety Reporting The rulemaking included the
population. An FDA marketing approval Requirements for Human Drug and following information collection under
does not guarantee a favorable coverage Biological Products and Safety the PRA that was not already included
decision. Reporting Requirements for in 21 CFR 312.32 and approved under
Bioavailability and Bioequivalence OMB control number 0910–0014.
III. Paperwork Reduction Act of 1995 Studies in Humans Section 312.32(c)(1)(ii) and (c)(1)(iii)
As stated in previous Federal Register requires reporting to FDA, in an IND
AGENCY: Food and Drug Administration,
safety report, of potential serious risks
notices related to the Parallel Review HHS.
from clinical trials within 15 calendar
pilot, due to FDA and CMS resource ACTION: Notice. days for findings from epidemiological
issues, the permanent program will
SUMMARY: The Food and Drug studies, pooled analyses of multiple
follow the same capacity limit by studies, or other clinical studies that
accepting no more than five candidates Administration (FDA or we) is
announcing that a proposed collection suggest a significant risk in humans
per year. As such, like the pilot exposed to the drug.
of information has been submitted to the
program, this collection of information Section 312.32(c)(1)(iii) specifies the
Office of Management and Budget
does not meet the definition of an (OMB) for review and clearance under requirements for reporting to FDA in an
information collection, as defined under the Paperwork Reduction Act of 1995 IND safety report potential serious risks
44 U.S.C. 3501–3520. (the PRA). from clinical trials within 15 calendar
IV. References DATES: Fax written comments on the days for findings from in vitro testing
collection of information by November that suggest a significant risk to humans.
The following references are on 23, 2016. Section 312.32(c)(1)(iv) requires
display in the Division of Dockets ADDRESSES: To ensure that comments on reporting to FDA in an IND safety report
Management (HFA–305), Food and Drug the information collection are received, within 15 calendar days of any
Administration, 5630 Fishers Lane, Rm. OMB recommends that written clinically important increase in the rate
1061, Rockville, MD 20852, and are comments be faxed to the Office of of occurrence of serious suspected
available for viewing by interested Information and Regulatory Affairs, adverse reactions over that listed in the
persons between 9 a.m. and 4 p.m., OMB, Attn: FDA Desk Officer, FAX: protocol or investigator brochure.
Monday through Friday; they are also 202–395–7285, or emailed to oira_ The rulemaking also included new
available electronically at http:// submission@omb.eop.gov. All information collection under the PRA
www.regulations.gov. FDA has verified comments should be identified with the by requiring safety reporting for
the Web site addresses, as of the date OMB control number 0910–0672. Also bioavailability and bioequivalence
include the FDA docket number found studies (21 CFR 320.31(d)).
this document publishes in the Federal
in brackets in the heading of this In tables 1 and 2 of this document, the
Register, but Web sites are subject to
document. estimates for ‘‘No. of Respondents,’’
change over time.
‘‘No. of Responses per Respondent,’’
1. FDA Guidance, ‘‘Requests for Feedback Investigational New Drug Safety and ‘‘Total Annual Responses’’ were
on Medical Device Submissions: The Pre- Reporting Requirements for Human obtained from the Center for Drug
Submission Program and Meetings with Food Drug and Biological Products and Evaluation and Research (CDER) and the
and Drug Administration Staff.’’ Available at Safety Reporting Requirements for Center for Biologics Evaluation and
http://www.fda.gov/downloads/ Bioavailability and Bioequivalence Research (CBER) reports and data
MedicalDevices/DeviceRegulationand Studies in Humans; OMB Control management systems for submissions
Guidance/GuidanceDocuments/ Number 0910–0672—Extension received in 2013, 2014, and 2015, and
UCM311176.pdf. In the Federal Register of October 31, from other sources familiar with the
Dated: October 18, 2016. 2013 (78 FR 65338), FDA published a number of submissions received under
Leslie Kux, document entitled ‘‘Investigational New the noted 21 CFR section. The estimates
Drug Safety Reporting Requirements for the ‘‘Hours per Response’’ are
Associate Commissioner for Policy, Food and
Drug Administration.
Human Drug and Biological Products unchanged based on information from
and Safety Reporting Requirements for CDER and CBER individuals familiar
Dated: October 5, 2016. with the burden associated with these
Bioavailability and Bioequivalence
Andy Slavitt, Studies in Humans.’’ The document reports and from prior estimates
Acting Administrator, Centers for Medicare clarified the Agency’s expectations for received from the pharmaceutical
sradovich on DSK3GMQ082PROD with NOTICES
& Medicaid Services. timely review, evaluation, and industry.
[FR Doc. 2016–25659 Filed 10–21–16; 8:45 am] submission of relevant and useful safety In the Federal Register of March 18,
BILLING CODE 4164–01–P information and implemented 2016 (81 FR 14860), we published a 60-
internationally harmonized definitions day notice requesting public comment
and reporting standards for IND safety on the proposed extension of this
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![73116 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Notices
collection of information. No comments FDA estimates the burden of this
were received. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
[CDER] 1
Number of Total Average
Number of responses
21 CFR section annual burden per Total hours
respondents per responses response
respondent
320.31(d) Bioavailability and Bioequivalence Safety Re-
ports .................................................................................. 13 15 195 14 2,730
312.32(c)(1)(ii) and (c)(1)(iii) IND Safety Reports ............... 100 6 600 12 7,200
312.32(c)(1)(iv) IND Safety Reports .................................... 10 1 10 12 120
Total (CDER) ................................................................ ........................ ........................ ........................ ........................ 10,050
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN
[CBER] 1
Number of
Total Average
Number of responses
21 CFR section annual burden per Total hours
respondents per responses response
respondent
320.31(d) Bioavailability and Bioequivalence Safety Re-
ports .................................................................................. 1 1 1 14 14
312.32(c)(1)(ii) and (c)(1)(iii) IND Safety Reports ............... 137 4 548 12 6,576
312.32(c)(1)(iv) IND Safety Reports .................................... 5 1.4 7 12 84
Total (CBER) ................................................................ ........................ ........................ ........................ ........................ 6,674
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 18, 2016. reauthorization of the Generic Drug User recommendations, FDA is extending the
Leslie Kux, Fee Amendments of 2012 (GDUFA). The comment period for the GDUFA
Associate Commissioner for Policy. Agency is taking this action to allow reauthorization draft recommendations
[FR Doc. 2016–25606 Filed 10–21–16; 8:45 am] interested persons the statutorily until November 16, 2016.
required 30 days to submit comments.
BILLING CODE 4164–01–P In addition, in FR Doc. 2016–23111,
Also, the document was published with
appearing on page 66035 in the Federal
an error in the SUPPLEMENTARY
INFORMATION section. This document
Register of Monday, September 26,
DEPARTMENT OF HEALTH AND
corrects that error. 2016, the following correction is made:
HUMAN SERVICES
DATES: FDA is extending the comment On page 66038, in the final paragraph
Food and Drug Administration period on the Generic Drug User Fee of the first column, the second sentence
[Docket No. FDA–2012–N–0882] recommendations published September is corrected to read: ‘‘Specifically, FDA
26, 2016 (81 FR 66035). Submit either would issue product-specific guidance
Generic Drug User Fees; Notice of electronic or written comments by identifying the methodology for
Public Meeting; Request for November 16, 2016. developing drugs and generating
Comments; Extension of Comment FOR FURTHER INFORMATION CONTACT: evidence needed to support ANDA
Period; Correction Derek Griffing, Center for Drug approval, for 90 percent of new
Evaluation and Research, Food and chemical entity new drug applications
AGENCY: Food and Drug Administration,
Drug Administration, 10903 New that are approved on or after October 1,
HHS.
Hampshire Ave., Bldg. 75, Rm. 1673, 2017, at least 2 years prior to the earliest
ACTION: Notice; extension of comment Silver Spring, MD 20993, 240–402–
period; correction. lawful filing date.’’
6980, email: GenericDrugPolicy@
fda.hhs.gov. Dated: October 18, 2016.
SUMMARY: The Food and Drug
Leslie Kux,
Administration (FDA) is announcing the SUPPLEMENTARY INFORMATION: In the
extension of the comment period and Federal Register of September 26, 2016, Associate Commissioner for Policy.
correcting a notice that appeared in the FDA published a request for comments [FR Doc. 2016–25603 Filed 10–21–16; 8:45 am]
Federal Register of Monday, September
sradovich on DSK3GMQ082PROD with NOTICES
on GDUFA reauthorization draft BILLING CODE 4164–01–P
26, 2016 (81 FR 66035). The document recommendations. The comment period
announced a public meeting entitled ends on November 7, 2016.
‘‘Generic Drug User Fees; Public Because the Agency posted the draft
Meeting; Request for Comments.’’ In recommendations on October 14, 2016,
that Federal Register notice, FDA and the statute requires a period of 30
requested comments on the draft days be provided for the public to
recommendations related to the provide comments on the draft
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Document Created: 2016-10-21 23:46:29
Document Modified: 2016-10-21 23:46:29
| 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 23, 2016. | |
| FR Citation | 81 FR 73115 |
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