Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Experience Reporting and Recordkeeping for Drug and Biological Products, 61277-61279 [2021-24236]

Download as PDF Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Notices Description: The U.S. Department of Health and Human Services (HHS) provides letters of certification to foreign national victims of severe forms of trafficking in persons under the authority of the Trafficking Victims Protection Act of 2000 (TVPA), as amended 22 U.S.C. Section 7105(b)(1)(C) and (E). HHS delegated this authority to OTIP. Certification is required for foreign national adult victims of human trafficking in the United States to apply for federally funded benefits and services. OTIP developed a form for potential victims and their advocates, including case managers, attorneys, law enforcement officers, service providers, and other representatives to provide the required information for certification to HHS in accordance with the TVPA of 2000, as amended. The RFC form (formerly titled Trafficking Victims Tracking System) was renamed in order to create continuity between the RFC and Request for Assistance for Child Victims of Human Trafficking (RFA) forms (OMB Control Number 0970– 0362). Since the RFC form originally received clearance, OTIP modernized its request process and launched Shepherd, an online case management system, to process requests for certification and assistance on behalf of foreign national adult and minor victims of trafficking. The PDF version of the form should only be used in exceptional circumstances when the online case management system is inaccessible. If a requester encounters issues submitting a request through Shepherd, they may submit the RFC form to OTIP as a password protected PDF to Trafficking@ acf.hhs.gov. The form asks the requester for their identifying information, 61277 identifying information for the foreign national adult in the event the form is submitted by a case manager, and information describing the victim’s case management service needs. The minor revisions made to this form enable OTIP to better fulfill its mandate in accordance with the TVPA of 2000, as amended. These revisions also enable OTIP to be more responsive to congressional inquiries, federal reporting requirements, and the needs of victims, as the information provided will be factored into policy and program development efforts. Respondents: Potential victims of a severe form of trafficking in persons and their advocates, including case managers, attorneys, law enforcement officers, service providers, and other representatives. ANNUAL BURDEN ESTIMATES Instrument Total number of respondents Total number of responses per respondent Average burden hours per response Total burden hours Annual burden hours 1,300 1 1 1,300 433 Request for Certification of Adult Victims of Human Trafficking ............................................................................... Estimated Total Annual Burden Hours: 433. Comments: The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Authority: 22 U.S.C. 7105. jspears on DSK121TN23PROD with NOTICES1 Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2021–24233 Filed 11–4–21; 8:45 am] BILLING CODE 4184–47–P VerDate Sep<11>2014 21:40 Nov 04, 2021 Jkt 256001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0515] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Experience Reporting and Recordkeeping for Drug and Biological Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA, Agency, 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. DATES: Submit written comments (including recommendations) on the collection of information by December 6, 2021. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. SUMMARY: PO 00000 Frm 00165 Fmt 4703 Sfmt 4703 Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0230. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Postmarketing Adverse Experience Reporting and Recordkeeping for Drug and Biologics Products OMB Control Number 0910–0230— Revision This information collection supports statutory provisions set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding the monitoring of FDA-regulated products. Specifically, E:\FR\FM\05NON1.SGM 05NON1 jspears on DSK121TN23PROD with NOTICES1 61278 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Notices FDA must be promptly informed of adverse experiences associated with the use of marketed drugs, including human drugs and biological products. Regulations in §§ 310.305 and 314.80 (21 CFR 310.305 and 314.80) implement reporting and recordkeeping requirements that enable FDA to take action to protect the public health from adverse drug experiences. All applicants who have received marketing approval for drug products are required to report serious, unexpected adverse drug experiences (15-day ‘‘Alert reports’’), as well as followup reports (§ 314.80(c)(1)) to FDA. This includes reports of all foreign or domestic adverse experiences as well as those based on information from applicable scientific literature and certain reports from postmarketing studies. Section 314.80(c)(1)(iii) pertains to such reports submitted by nonapplicants. Under § 314.80(c)(2), applicants must provide periodic reports of adverse drug experiences. For the reporting interval, a periodic report includes reports of serious, expected adverse drug experiences, all nonserious adverse drug experiences, and an index of these reports; a narrative summary and analysis of adverse drug experiences; an analysis of the 15-day Alert reports submitted during the reporting interval; and a history of actions taken because of adverse drug experiences. Under § 314.80(j), applicants must keep for 10 years records of all adverse drug experience reports known to the applicant. For marketed prescription drug products without approved new drug applications (NDAs) or abbreviated new drug applications (ANDAs), manufacturers, packers, and distributors are required to report to FDA serious, unexpected adverse drug experiences as well as followup reports (§ 310.305(c)). Section 310.305(c)(5) pertains to the submission of followup reports to reports forwarded to the manufacturers, packers, and distributors by FDA. Under § 310.305(g), each manufacturer, packer, and distributor shall maintain for 10 years records of all adverse drug experiences required to be reported. Section 760 of the FD&C Act (21 U.S.C. 379aa) also provides for mandatory safety reporting for over-thecounter (OTC) human drug products not subject to applications approved under section 505 of the FD&C Act (21 U.S.C. 355) (NDAs or ANDAs). These requirements apply to all OTC drug products marketed without an approved application, including those marketed under the OTC Drug Monograph Review process (whether or not subject to a final monograph), those marketed outside the VerDate Sep<11>2014 21:40 Nov 04, 2021 Jkt 256001 monograph system, and including those that have been discontinued from marketing but for which a report of an adverse event was received. Under 21 CFR 329.100, respondents must submit reports according to section 760 of the FD&C Act in an electronic format. To assist respondents with implementation of section 760 of the FD&C Act, FDA developed the guidance for industry entitled ‘‘Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application,’’ available at https:// www.fda.gov/media/77193/download. The guidance document discusses what should be included in a serious adverse drug event report submitted under section 760(b)(1) of the FD&C Act, including how to submit these reports and followup reports under section 760(c)(2) of the FD&C Act. Section 760(e) of the FD&C Act also requires that responsible persons maintain records of nonprescription drug adverse event reports, whether the event is serious or not, for a period of 6 years. FDA’s guidance recommends that respondents maintain records of efforts to obtain the minimum data elements for a report of a serious adverse drug event and any followup reports. The primary purpose of FDA’s adverse drug experience reporting system is to enable identification of signals for potentially serious safety problems with marketed drugs. Although premarket testing discloses a general safety profile of a new drug’s comparatively common adverse effects, the larger and more diverse patient populations exposed to the marketed drug provide the opportunity to collect information on rare, latent, and longterm effects. Signals are obtained from a variety of sources, including reports from patients, treating physicians, foreign regulatory agencies, and clinical investigators. Information derived from the adverse drug experience reporting system contributes directly to increased public health protection because the information enables FDA to make important changes to the product’s labeling (such as adding a new warning), to make decisions about risk evaluation and mitigation strategies or the need for postmarketing studies or clinical trials and, when necessary, to initiate removal of a product from the market. In addition, this information collection includes an International Council for Harmonisation (ICH) guidance for industry entitled ‘‘Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) PO 00000 Frm 00166 Fmt 4703 Sfmt 4703 Format (Periodic Benefit-Risk Evaluation Report),’’ available at https:// www.fda.gov/media/85520/download. The guidance describes the conditions under which applicants may use the ICH3 E2C(R2) Periodic Benefit-Risk Evaluation Report format for certain types of adverse event reporting. FDA regulations in §§ 314.80(c)(2) and 600.80(c)(2) (21 CFR 600.80(c)(2)) require applicants to submit postmarketing periodic safety reports for each approved application. The reports must be submitted quarterly for the first 3 years following the U.S. approval date and annually thereafter and must contain the information described in §§ 314.80(c)(2)(ii) and 600.80(c)(2)(ii) (the information collection associated with 21 CFR part 600—Biological Products, is approved under OMB control number 0910–0308). The Agency guidance assists respondents with satisfying the regulatory requirements in an alternative format, noting that the process differs depending on whether an applicable periodic safety update report (PSUR) waiver is in place. The information collection burden for waivers of a PSUR are currently approved in OMB control number 0910–0771; however, it is being consolidated with this information collection for administrative efficiency. Similarly, the information collection accounts for burden that may be applicable to the guidance document, ‘‘Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic,’’ available at https:// www.fda.gov/media/72498/download. In response to the Coronavirus Disease 2019 public health emergency, we revised the Agency guidance document to provide recommendations for recordkeeping applicable to any pandemic, not just influenza, including recommendations for planning, notification, and documentation for continuity of operations for firms that report postmarketing adverse events during any pandemic. Respondents to this collection of information are: (1) Manufacturers, packers, distributors, and applicants of FDA-regulated drug and biologic products; (2) manufacturers, packers, and distributors of marketed prescription drug products without an FDA-approved application; and (3) manufacturers, packers, and distributors of marketed nonprescription drug products, including OTC drug products marketed without an approved application, OTC drug products marketed under the OTC Drug Monograph Review process (whether subject to a final monograph or not), and E:\FR\FM\05NON1.SGM 05NON1 61279 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Notices drug products marketed outside the monograph system. In the Federal Register of June 30, 2021 (86 FR 34759), we published a 60- day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR section or type of respondent and activity Number of responses per respondent Total annual responses Average burden per response Total hours 310.305(c)(5) ..................................................................................................... 314.80(c)(1)(iii) .................................................................................................. 314.80(c)(2) ....................................................................................................... Reports of serious adverse drug events (§ 329.100) ....................................... Applicants that have a PSUR waiver for an approved application .................. Applicants that do not have a PSUR waiver for an approved application ....... Notifying FDA when normal reporting is not feasible ....................................... 3 5 820 285 55 29 350 1 1 17.32 690 3.4 2.3 1 3 5 14,202 196,650 187 67 350 1 1 60 6 1 2 8 3 5 852,120 1,179,900 187 134 2,800 Total 2 ......................................................................................................... .......................... ........................ 211,464 .......................... 2,035,149 1 The capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR section or FD&C act section and activity 310.305 ............................................................................................................. 314.80(j) ............................................................................................................ Recordkeeping of nonprescription drug adverse event reports (Section 760(e)(1) of the FD&C Act) ........................................................................... Adding Adverse Event report planning to Continuity of Operations Plans ...... Maintaining documentation of pandemic conditions and resultant high absenteeism ............................................................................................................ Maintaining records to identify what reports have been stored and when the reporting process was restored ..................................................................... Total 2 ......................................................................................................... Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 25 352 1 1,870 25 658,240 16 16 400 10,531,840 300 100 885.6667 1 265,700 100 8 50 2,125,600 5,000 350 1 350 8 2,800 350 1 350 8 2,800 .......................... ........................ 924,765 .......................... 12,668,440 1 There are no capital costs or operating costs associated with this collection of information. 2 There are maintenance costs of approximately $22,000 annually. We have increased our estimate to reflect expected adjustments to the information collection since our last submission for OMB review and approval. Sec. 110.100 contains information that is either duplicative of other information we have published or no longer reflects the Agency’s current thinking. Dated: November 1, 2021. Lauren K. Roth, Associate Commissioner for Policy. DATES: [FR Doc. 2021–24236 Filed 11–4–21; 8:45 am] Tiffany Kelley, Office of Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–348–1970, Tiffany.Kelley@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA originally issued CPG Sec. 110.100 on October 1, 1980, in the Agency’s Manual of Compliance Policy Guides. The CPG was revised periodically but has not been revised since April 14, 2000. Since FDA last revised CPG Sec. 110.100, the Agency issued separate guidance for industry on FDA export certification in 2004. FDA revised that guidance in 2005, 2019, and, most recently, in August 2021. The August 2021 version of the guidance for industry, entitled ‘‘FDA Export Certification,’’ provides the Agency’s current guidance regarding FDA issuance of export certification. Persons with access to the internet may obtain The withdrawal is effective November 5, 2021. FOR FURTHER INFORMATION CONTACT: BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–1996–D–0405] Compliance Policy Guide Sec. 110.100; Withdrawal of Guidance AGENCY: Food and Drug Administration, HHS. jspears on DSK121TN23PROD with NOTICES1 ACTION: Notice; withdrawal. The Food and Drug Administration (FDA, the Agency, or we) is announcing the withdrawal of Compliance Policy Guide Sec. 110.100, ‘‘Certification for Exports’’ (CPG Sec. 110.100), which FDA issued in 1980. We are taking this action because CPG SUMMARY: VerDate Sep<11>2014 21:40 Nov 04, 2021 Jkt 256001 PO 00000 Frm 00167 Fmt 4703 Sfmt 4703 the guidance at https://www.fda.gov/ regulatory-information/search-fdaguidance-documents. Although this guidance originally complemented the content in CPG Sec. 110.100, changes in the document over time have increasingly resulted in CPG Sec. 110.100 containing duplicative and outdated information. Thus, FDA is withdrawing CPG Sec. 110.100 in its entirety. Dated: November 1, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–24234 Filed 11–4–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Assistant Secretary for Administration; Delegation of Authority Notice is hereby given that I have amended the delegation of authority to the Assistant Secretary for Preparedness and Response (ASPR); the Director, Centers for Disease Control and Prevention (CDC); the Administrator, Health Resources and Services Administration (HRSA); the Director, E:\FR\FM\05NON1.SGM 05NON1

Agencies

[Federal Register Volume 86, Number 212 (Friday, November 5, 2021)]
[Notices]
[Pages 61277-61279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24236]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0515]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Postmarketing Adverse 
Experience Reporting and Recordkeeping for Drug and Biological Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, 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.

DATES: Submit written comments (including recommendations) on the 
collection of information by December 6, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0230. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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.

Postmarketing Adverse Experience Reporting and Recordkeeping for Drug 
and Biologics Products

OMB Control Number 0910-0230--Revision

    This information collection supports statutory provisions set forth 
in the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding the 
monitoring of FDA-regulated products. Specifically,

[[Page 61278]]

FDA must be promptly informed of adverse experiences associated with 
the use of marketed drugs, including human drugs and biological 
products. Regulations in Sec. Sec.  310.305 and 314.80 (21 CFR 310.305 
and 314.80) implement reporting and recordkeeping requirements that 
enable FDA to take action to protect the public health from adverse 
drug experiences. All applicants who have received marketing approval 
for drug products are required to report serious, unexpected adverse 
drug experiences (15-day ``Alert reports''), as well as followup 
reports (Sec.  314.80(c)(1)) to FDA. This includes reports of all 
foreign or domestic adverse experiences as well as those based on 
information from applicable scientific literature and certain reports 
from postmarketing studies. Section 314.80(c)(1)(iii) pertains to such 
reports submitted by nonapplicants.
    Under Sec.  314.80(c)(2), applicants must provide periodic reports 
of adverse drug experiences. For the reporting interval, a periodic 
report includes reports of serious, expected adverse drug experiences, 
all nonserious adverse drug experiences, and an index of these reports; 
a narrative summary and analysis of adverse drug experiences; an 
analysis of the 15-day Alert reports submitted during the reporting 
interval; and a history of actions taken because of adverse drug 
experiences. Under Sec.  314.80(j), applicants must keep for 10 years 
records of all adverse drug experience reports known to the applicant.
    For marketed prescription drug products without approved new drug 
applications (NDAs) or abbreviated new drug applications (ANDAs), 
manufacturers, packers, and distributors are required to report to FDA 
serious, unexpected adverse drug experiences as well as followup 
reports (Sec.  310.305(c)). Section 310.305(c)(5) pertains to the 
submission of followup reports to reports forwarded to the 
manufacturers, packers, and distributors by FDA. Under Sec.  
310.305(g), each manufacturer, packer, and distributor shall maintain 
for 10 years records of all adverse drug experiences required to be 
reported.
    Section 760 of the FD&C Act (21 U.S.C. 379aa) also provides for 
mandatory safety reporting for over-the-counter (OTC) human drug 
products not subject to applications approved under section 505 of the 
FD&C Act (21 U.S.C. 355) (NDAs or ANDAs). These requirements apply to 
all OTC drug products marketed without an approved application, 
including those marketed under the OTC Drug Monograph Review process 
(whether or not subject to a final monograph), those marketed outside 
the monograph system, and including those that have been discontinued 
from marketing but for which a report of an adverse event was received. 
Under 21 CFR 329.100, respondents must submit reports according to 
section 760 of the FD&C Act in an electronic format.
    To assist respondents with implementation of section 760 of the 
FD&C Act, FDA developed the guidance for industry entitled 
``Postmarketing Adverse Event Reporting for Nonprescription Human Drug 
Products Marketed Without an Approved Application,'' available at 
https://www.fda.gov/media/77193/download. The guidance document 
discusses what should be included in a serious adverse drug event 
report submitted under section 760(b)(1) of the FD&C Act, including how 
to submit these reports and followup reports under section 760(c)(2) of 
the FD&C Act.
    Section 760(e) of the FD&C Act also requires that responsible 
persons maintain records of nonprescription drug adverse event reports, 
whether the event is serious or not, for a period of 6 years. FDA's 
guidance recommends that respondents maintain records of efforts to 
obtain the minimum data elements for a report of a serious adverse drug 
event and any followup reports.
    The primary purpose of FDA's adverse drug experience reporting 
system is to enable identification of signals for potentially serious 
safety problems with marketed drugs. Although premarket testing 
discloses a general safety profile of a new drug's comparatively common 
adverse effects, the larger and more diverse patient populations 
exposed to the marketed drug provide the opportunity to collect 
information on rare, latent, and long-term effects. Signals are 
obtained from a variety of sources, including reports from patients, 
treating physicians, foreign regulatory agencies, and clinical 
investigators. Information derived from the adverse drug experience 
reporting system contributes directly to increased public health 
protection because the information enables FDA to make important 
changes to the product's labeling (such as adding a new warning), to 
make decisions about risk evaluation and mitigation strategies or the 
need for postmarketing studies or clinical trials and, when necessary, 
to initiate removal of a product from the market.
    In addition, this information collection includes an International 
Council for Harmonisation (ICH) guidance for industry entitled 
``Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) 
Format (Periodic Benefit-Risk Evaluation Report),'' available at 
https://www.fda.gov/media/85520/download. The guidance describes the 
conditions under which applicants may use the ICH3 E2C(R2) Periodic 
Benefit-Risk Evaluation Report format for certain types of adverse 
event reporting. FDA regulations in Sec. Sec.  314.80(c)(2) and 
600.80(c)(2) (21 CFR 600.80(c)(2)) require applicants to submit 
postmarketing periodic safety reports for each approved application. 
The reports must be submitted quarterly for the first 3 years following 
the U.S. approval date and annually thereafter and must contain the 
information described in Sec. Sec.  314.80(c)(2)(ii) and 
600.80(c)(2)(ii) (the information collection associated with 21 CFR 
part 600--Biological Products, is approved under OMB control number 
0910-0308). The Agency guidance assists respondents with satisfying the 
regulatory requirements in an alternative format, noting that the 
process differs depending on whether an applicable periodic safety 
update report (PSUR) waiver is in place. The information collection 
burden for waivers of a PSUR are currently approved in OMB control 
number 0910-0771; however, it is being consolidated with this 
information collection for administrative efficiency.
    Similarly, the information collection accounts for burden that may 
be applicable to the guidance document, ``Postmarketing Adverse Event 
Reporting for Medical Products and Dietary Supplements During a 
Pandemic,'' available at https://www.fda.gov/media/72498/download. In 
response to the Coronavirus Disease 2019 public health emergency, we 
revised the Agency guidance document to provide recommendations for 
recordkeeping applicable to any pandemic, not just influenza, including 
recommendations for planning, notification, and documentation for 
continuity of operations for firms that report postmarketing adverse 
events during any pandemic.
    Respondents to this collection of information are: (1) 
Manufacturers, packers, distributors, and applicants of FDA-regulated 
drug and biologic products; (2) manufacturers, packers, and 
distributors of marketed prescription drug products without an FDA-
approved application; and (3) manufacturers, packers, and distributors 
of marketed nonprescription drug products, including OTC drug products 
marketed without an approved application, OTC drug products marketed 
under the OTC Drug Monograph Review process (whether subject to a final 
monograph or not), and

[[Page 61279]]

drug products marketed outside the monograph system.
    In the Federal Register of June 30, 2021 (86 FR 34759), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of
   21 CFR section or type of       Number of      responses per   Total annual    Average burden    Total hours
    respondent and activity       respondents      respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
310.305(c)(5).................                3               1               3                1               3
314.80(c)(1)(iii).............                5               1               5                1               5
314.80(c)(2)..................              820           17.32          14,202               60         852,120
Reports of serious adverse                  285             690         196,650                6       1,179,900
 drug events (Sec.   329.100).
Applicants that have a PSUR                  55             3.4             187                1             187
 waiver for an approved
 application..................
Applicants that do not have a                29             2.3              67                2             134
 PSUR waiver for an approved
 application..................
Notifying FDA when normal                   350               1             350                8           2,800
 reporting is not feasible....
                               ---------------------------------------------------------------------------------
    Total \2\.................  ...............  ..............         211,464  ...............       2,035,149
----------------------------------------------------------------------------------------------------------------
\1\ The capital costs or operating and maintenance costs associated with this collection of information are
  approximately $25,000 annually.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                     Average burden
  21 CFR section or FD&C act       Number of       records per    Total annual         per          Total hours
     section and activity        recordkeepers    recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
310.305.......................               25               1              25               16             400
314.80(j).....................              352           1,870         658,240               16      10,531,840
Recordkeeping of                            300        885.6667         265,700                8       2,125,600
 nonprescription drug adverse
 event reports (Section
 760(e)(1) of the FD&C Act)...
Adding Adverse Event report                 100               1             100               50           5,000
 planning to Continuity of
 Operations Plans.............
Maintaining documentation of                350               1             350                8           2,800
 pandemic conditions and
 resultant high absenteeism...
Maintaining records to                      350               1             350                8           2,800
 identify what reports have
 been stored and when the
 reporting process was
 restored.....................
                               ---------------------------------------------------------------------------------
    Total \2\.................  ...............  ..............         924,765  ...............      12,668,440
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating costs associated with this collection of information.
\2\ There are maintenance costs of approximately $22,000 annually.

    We have increased our estimate to reflect expected adjustments to 
the information collection since our last submission for OMB review and 
approval.

    Dated: November 1, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24236 Filed 11-4-21; 8:45 am]
BILLING CODE 4164-01-P

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