83 FR 55900 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Drug and Biological Product Experience Reporting and Recordkeeping
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 217 (November 8, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 217 (November 8, 2018)
| Page Range | 55900-55902 | |
| FR Document | 2018-24442 |
[Federal Register Volume 83, Number 217 (Thursday, November 8, 2018)] [Notices] [Pages 55900-55902] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-24442] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0253] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Drug and Biological Product Experience Reporting and Recordkeeping 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 December 10, 2018. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of [[Page 55901]] 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 0910-0230. 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 Drug and Biological Product Experience Reporting and Recordkeeping OMB Control Number 0910-0230--Revision Sections 201, 502, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 352, 355, and 371) (FD&C Act) require that marketed drugs be safe and effective. To monitor the safety and efficacy of drugs that are on the market, FDA must be promptly informed of adverse experiences associated with the use of marketed drugs. We have issued regulations at Sec. Sec. 310.305 and 314.80 (21 CFR 310.305 and 314.80) to implement reporting and recordkeeping requirements that enable us to take necessary action to protect the public health from adverse drug experiences. All applicants who have received marketing approval of drug products are required to report serious, unexpected adverse drug experiences (15-day ``Alert reports''), as well as follow-up reports (Sec. 314.80(c)(1)). 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. A periodic report includes, for the reporting interval, reports of serious, expected adverse drug experiences and 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 or abbreviated new drug applications, manufacturers, packers, and distributors are required to report to FDA serious, unexpected adverse drug experiences as well as follow-up reports (Sec. 310.305(c)). Section 310.305(c)(5) pertains to the submission of follow-up 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 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 Act (new drug applications or abbreviated new drug applications). 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 part 329.100 respondents must submit section 760 reports in an electronic format. To assist respondents with implementation of section 760 we developed the guidance document entitled ``Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.'' 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 (21 U.S.C. 379aa(b)(1)), including follow-up reports under 760(c)(2) of the FD&C Act (21 U.S.C. 379aa(c)(2)), and how to submit these reports. Section 760(e) of the FD&C Act (21 U.S.C. 379aa(e)) also requires that responsible persons maintain records of nonprescription adverse event reports, whether or not the event is serious, for a period of 6 years. The 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 follow-up reports. The information collection associated with the guidance is currently approved under OMB Control No. 0910-0636, however we are now consolidating it into this collection. 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 us 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 drug from the market. In the Federal Register of July 11, 2018 (83 FR 32132) we published a 60-day notice requesting public comment on the proposed collection of information approved under OMB Control No. 0910-0230. One comment from an anonymous source referred us to attachments that were not successfully transmitted. We are therefore unable to address this comment. In the Federal Register of August 15, 2018 (83 FR 40520) we published a 60-day notice requesting public comment on the collection of information approved under OMB Control No 0910-0636. No comments were received. Respondents to the collection of information are manufacturers, packers, distributors, and applicants of FDA-regulated drug and biological products. The following estimates are based on our knowledge of adverse drug experience reporting, including the time needed to prepare the reports and the number of reports submitted to the Agency. We estimate the burden of this collection of information as follows: [[Page 55902]] Table 1--Estimated Annual Reporting Burden \1\ \2\ ---------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of responses per Total annual Average burden Total hours 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).................... 810 17.19 13,923.90 60 835,434 Reports of serious adverse drug 283 687.099 194,449 6 1,166,694 events (21 U.S.C. 379aa((b) and (c))........................... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 2,002,136 ---------------------------------------------------------------------------------------------------------------- \1\ The reporting burden for Sec. 310.305(c)(1), (2), and (3), and Sec. 314.80(c)(1)(i) and (ii) is covered under OMB control number 0910-0645. \2\ 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\ \2\ ---------------------------------------------------------------------------------------------------------------- Number of Average burden 21 CFR section Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeping ---------------------------------------------------------------------------------------------------------------- 310.305(g)...................... 25 1 25 16 400 314.80(j)....................... 352 1,870 658,240 16 10,531,840 Recordkeeping (21 U.S.C. 300 885.6667 265,700 8 2,125,600 379aa(e)(1))................... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 12,657,840 ---------------------------------------------------------------------------------------------------------------- \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. Based on submissions received we have increased our burden estimate for reporting under part 314.80(c)(2) and recordkeeping under part 314.80(j). Additionally, and as previously stated, we are consolidating burden associated with reporting and recordkeeping under section 760 of the FD&C Act. Based on our records, we received 194,449 total annual reports from approximately 283 respondents for nonprescription drugs marketed without an approved application. We estimate each submission takes approximately 6 hours to prepare and submit. We estimate that there are 265,700 records per year maintained by approximately 300 respondents, and that it takes 8 hours to maintain each record. Dated: November 2, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-24442 Filed 11-7-18; 8:45 am] BILLING CODE 4164-01-P
![55900 Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices
Based on FDA data, we estimate that NDC and to obtain a labeler code. The creating and uploading the SPL file.
1,480 respondents will submit 2,960 estimate for the number of drugs subject Although most firms will already have
new establishment registrations to the listing requirements includes PET prepared an SOP for the electronic
annually. Based on the number of drugs and approximately 30 plasma submission of drug establishment
registered establishments in our derivatives. The estimates for the registration and drug listing
database, we estimate 10,000 registrants number of June and December reviews information, each year additional firms
will provide 10,000 annual reviews and and updates of listing information will need to create an SOP. As reflected
updates of registration information include the number of changes to drug in table 2, FDA estimates that
(including expedited updates) or characteristics pertaining to the drug approximately 1,000 firms will expend
reviews and certifications that no product code to obtain a new NDC and 40 hours to prepare, review, and
changes have occurred. The estimates the reports of the withdrawal of an approve an SOP, for a total of 40,000
include the registration of approved drug from sale under hours annually.
establishments for both domestic and § 314.81(b)(3)(iii) (21 CFR Cumulatively, the information
foreign manufacturers, repackers, 314.81(b)(3)(iii)). collection reflects a decrease of 3,295 in
relabelers, and drug product salvagers, Based on our familiarity with the time both annual responses and burden
and registration information submitted required to input listing information hours. This adjustment results from
by anyone acting as an authorized agent electronically since June 2009, we eliminating burden previously
for an establishment that manufactures, estimate that it will take registrants 1 attributable to guidance
repacks, relabels, or salvages drugs. The hour and 30 minutes to submit recommendations for creating drug
estimates include an additional 80 information electronically for each drug establishment registration and drug
positron emission tomography (PET) they list for the first time (for both listing files for electronic submission.
drug producers who are not exempt foreign and domestic registrant listings). Because electronic registration and
from registration and approximately 30 These estimates are an average of the listing is now mandatory, we believe
manufacturers of plasma derivatives. time it will take manufacturers, respondents have since developed and
We estimate that it will take 1 hour repackers, relabelers, and drug product implemented SOPs consistent with
for registrants to submit initial salvagers, with drug product salvagers meeting the technical format
registration information electronically taking considerably less time than specifications set forth in the
for each new establishment. We also manufacturers. The estimates include regulations and we no longer attribute
estimate that it will take approximately the time for submitting the content of burden to this activity.
30 minutes for each annual review and labeling and other labeling in electronic
update of registration information format. (For drugs subject to an Dated: November 5, 2018.
(including any expedited updates) or approved marketing application, the Leslie Kux,
each review and certification that no electronic submission of the content of Associate Commissioner for Policy.
changes have occurred. The burden labeling under § 314.50(l)(1)(i) is [FR Doc. 2018–24440 Filed 11–7–18; 8:45 am]
hour estimates above are based on our approved under OMB control number BILLING CODE 4164–01–P
familiarity with the amount of time it 0910–0001.) We also estimate that it
takes registrants to input registration will take 45 minutes for each June and
information electronically since June December review and update. These DEPARTMENT OF HEALTH AND
2009. The estimates are an average of estimates represent the average amount HUMAN SERVICES
the time it would take to register a of time to review and update listing
domestic or foreign establishment and information or to review and certify that Food and Drug Administration
an average of the time it would take to no changes have occurred. The [Docket No. FDA–2012–N–0253]
review registration information and estimates include the time for
update several registration items in the submitting any labeling for each drug, Agency Information Collection
database or review registration changes to the drug’s characteristics Activities; Submission for Office of
information and only certify that no submitted for a new NDC, and reports Management and Budget Review;
changes have occurred. of the withdrawal of an approved drug Comment Request; Postmarketing
Based on the number of drugs listed from sale under § 314.81(b)(3)(iii). Adverse Drug and Biological Product
annually since June 2009, we estimate In 2009, to help respondents Experience Reporting and
that approximately 1,713 registrants will transition to the current electronic Recordkeeping
report 12,469 new listings annually reporting requirements, FDA issued the
(including the information submitted to guidance for industry entitled AGENCY: Food and Drug Administration,
obtain a labeler code and to reserve an ‘‘Providing Regulatory Submissions in HHS.
NDC for future use). Electronic Format—Drug Establishment ACTION: Notice.
Based on the number of drugs in our Registration and Drug Listing.’’ The
listing database and the current number document provides guidance to industry SUMMARY: The Food and Drug
of changes to listing information on the statutory requirement to submit Administration (FDA) is announcing
submitted, we estimate 5,300 registrants electronically drug establishment that a proposed collection of
will each report 20 reviews and updates registration and drug listing information has been submitted to the
(including the information submitted to information. The guidance describes the Office of Management and Budget
revise an NDC) for a total of 106,000 types of information to include for (OMB) for review and clearance under
annually. purposes of drug establishment the Paperwork Reduction Act of 1995.
daltland on DSKBBV9HB2PROD with NOTICES
The estimates for the number of drug registration and drug listing and how to DATES: Fax written comments on the
listings include both domestic and prepare and submit the information in collection of information by December
foreign listings, listings submitted by an electronic format (Structured Product 10, 2018.
registrants for products sold under their Labeling (SPL) files) that FDA can ADDRESSES: To ensure that comments on
own names as well as products intended process, review, and archive. The the information collection are received,
for private label distribution, and burden attributed to the guidance OMB recommends that written
information submitted related to an includes the preparation of an SOP for comments be faxed to the Office of
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![55902 Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response
310.305(c)(5) ........................................................................ 3 1 3 1 3
314.80(c)(1)(iii) ..................................................................... 5 1 5 1 5
314.80(c)(2) .......................................................................... 810 17.19 13,923.90 60 835,434
Reports of serious adverse drug events (21 U.S.C.
379aa((b) and (c)) ............................................................ 283 687.099 194,449 6 1,166,694
Total .............................................................................. ........................ ........................ ........................ ........................ 2,002,136
1 The reporting burden for § 310.305(c)(1), (2), and (3), and § 314.80(c)(1)(i) and (ii) is covered under OMB control number 0910–0645.
2 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 2
Number of Average
Number of Total annual Total
21 CFR section records per burden per
recordkeepers records hours
recordkeeper recordkeeping
310.305(g) ............................................................................ 25 1 25 16 400
314.80(j) ............................................................................... 352 1,870 658,240 16 10,531,840
Recordkeeping (21 U.S.C. 379aa(e)(1)) .............................. 300 885.6667 265,700 8 2,125,600
Total .............................................................................. ........................ ........................ ........................ ........................ 12,657,840
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.
Based on submissions received we provisions set forth in sections Place: National Institutes of Health,
have increased our burden estimate for 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Neuroscience Center, 6001 Executive
reporting under part 314.80(c)(2) and as amended. The grant applications and Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
recordkeeping under part 314.80(j). the discussions could disclose
Additionally, and as previously stated, confidential trade secrets or commercial Contact Person: Ipolia R. Ramadan, Ph.D.,
Scientific Review Officer, Office of
we are consolidating burden associated property such as patentable material, Extramural Policy and Review, Division of
with reporting and recordkeeping under and personal information concerning Extramural Research, National Institute on
section 760 of the FD&C Act. Based on individuals associated with the grant Drug Abuse, NIH, DHHS, 6001 Executive
our records, we received 194,449 total applications, the disclosure of which Boulevard, Room 4228, MSC 9550, Bethesda,
annual reports from approximately 283 would constitute a clearly unwarranted MD 20892, 301–827–5842, ramadanir@
respondents for nonprescription drugs invasion of personal privacy. mail.nih.gov.
marketed without an approved This notice is being published less than 15
Name of Committee: National Institute on days prior to the meeting due to the timing
application. We estimate each Drug Abuse Special Emphasis Panel; R13 limitations imposed by the review and
submission takes approximately 6 hours Conference Grant Review. funding cycle.
to prepare and submit. We estimate that Date: November 14, 2018. (Catalogue of Federal Domestic Assistance
there are 265,700 records per year Time: 12:00 p.m. to 3:30 p.m. Program Nos.: 93.279, Drug Abuse and
maintained by approximately 300 Agenda: To review and evaluate grant Addiction Research Programs, National
respondents, and that it takes 8 hours to applications. Institutes of Health, HHS)
maintain each record. Place: National Institutes of Health,
Dated: November 2, 2018.
Neuroscience Center, 6001 Executive
Dated: November 2, 2018. Natasha M. Copeland,
Boulevard, Rockville, MD 20852, (Telephone
Leslie Kux, Conference Call). Program Analyst, Office of Federal Advisory
Associate Commissioner for Policy. Contact Person: Ipolia R. Ramadan, Ph.D., Committee Policy.
[FR Doc. 2018–24442 Filed 11–7–18; 8:45 am] Scientific Review Officer, Office of [FR Doc. 2018–24470 Filed 11–7–18; 8:45 am]
BILLING CODE 4164–01–P Extramural Policy and Review, Division of BILLING CODE 4140–01–P
Extramural Research, National Institute on
Drug Abuse, NIH, DHHS, 6001 Executive
DEPARTMENT OF HEALTH AND Boulevard, Room 4228, MSC 9550, Bethesda, DEPARTMENT OF HEALTH AND
HUMAN SERVICES MD 20892, 301–827–5842, ramadanir@ HUMAN SERVICES
mail.nih.gov.
National Institutes of Health This notice is being published less than 15 National Institutes of Health
days prior to the meeting due to the timing
National Institute on Drug Abuse; limitations imposed by the review and National Institute of Mental Health;
funding cycle.
daltland on DSKBBV9HB2PROD with NOTICES
Notice of Closed Meetings Notice of Closed Meetings
Name of Committee: National Institute on
Pursuant to section 10(d) of the Drug Abuse Special Emphasis Panel; Multi- Pursuant to section 10(d) of the
Federal Advisory Committee Act, as site Clinical Trials. Federal Advisory Committee Act, as
amended, notice is hereby given of the Date: November 16, 2018. amended, notice is hereby given of the
following meetings. Time: 12:00 p.m. to 3:00 p.m. following meetings.
The meetings will be closed to the Agenda: To review and evaluate grant The meetings will be closed to the
public in accordance with the applications. public in accordance with the
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Document Created: 2018-11-08 06:23:15
Document Modified: 2018-11-08 06:23:15
| 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 December 10, 2018. | |
| 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] | |
| FR Citation | 83 FR 55900 |
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