83 FR 40520 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 158 (August 15, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 158 (August 15, 2018)
| Page Range | 40520-40522 | |
| FR Document | 2018-17526 |
[Federal Register Volume 83, Number 158 (Wednesday, August 15, 2018)] [Notices] [Pages 40520-40522] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-17526] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0915] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information entitled ``Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.'' [[Page 40521]] DATES: Submit either electronic or written comments on the collection of information by October 15, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 15, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 15, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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-2011-N-0915 for ``Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.'' Received comments, those filed in a timely manner (see ADDRESSES), 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. 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: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application; OMB Control Number 0910-0636--Extension This information collection supports Agency guidance directed to manufacturers, packers, and/or distributors whose names appear on the label of a nonprescription drug marketed in the United States under section 502(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352(b)(1)). FDA is requesting public comment on estimates of annual submissions from these respondents, as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109-462) and described in the guidance. The guidance document discusses what should be included in a serious adverse drug event report submitted under section 760(b)(1) [[Page 40522]] of the FD&C Act (21 U.S.C. 379aa(b)(1)), including followup reports under 760(c)(2) of the FD&C Act (21 U.S.C. 379aa(c)(2)), and how to submit these reports. The estimates for the annual reporting and recordkeeping burdens are based on FDA data on the number of adverse drug experience reports submitted for nonprescription drug products marketed without an approved application and on prior input from comments received from prior Federal Register publications. Based on FDA records, we received 194,449 total annual responses from approximately 283 respondents for nonprescription drugs marketed without an approved application. We estimate that each submission will take approximately 6 hours to prepare and submit. Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Reports of serious adverse drug events (21 U.S.C. 379aa((b) and 283 687.099 194,449 6 1,166,694 (c)).............................................................. -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. 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 followup reports. We estimate that there are approximately 265,700 records per year maintained by approximately 300 respondents, and that it takes approximately 8 hours to maintain each record. Table 2--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden Activity Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeping -------------------------------------------------------------------------------------------------------------------------------------------------------- Recordkeeping (21 U.S.C. 379aa(e)(1)).............................. 300 885.6667 265,700 8 2,125,600 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Our estimated burden for the information collection reflects an overall increase. We attribute this adjustment to an increase in the number of submissions we received in the last few years. Dated: August 9, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-17526 Filed 8-14-18; 8:45 am] BILLING CODE 4164-01-P
![40520 Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices
795–7732 or kristen.hudgins@ information, including the validity of the caregiver portion of the PPR has
acl.hhs.gov. the methodology and assumptions used been updated to collect more
SUPPLEMENTARY INFORMATION: Under the to determine burden estimates; information around types of caregivers
PRA (44 U.S.C. 3501–3520), Federal (3) Ways to enhance the quality, served and unduplicated numbers of
agencies must obtain approval from the utility, and clarity of the information to caregivers. Another element added has
Office of Management and Budget be collected; and to do with information on expenditures.
(OMB) for each collection of (4) Ways to minimize the burden of This data collection will also support
information they conduct or sponsor. the collection of information on ACL in tracking performance outcomes
‘‘Collection of information’’ is defined respondents, including through the use and efficiency measures with respect to
in 44 U.S.C. 3502(3) and 5 CFR of automated collection techniques the annual and long-term performance
1320.3(c) and includes agency requests when appropriate, and other forms of
targets established in compliance with
or requirements that members of the information technology.
the Government Performance Results
public submit reports, keep records, or The data collection materials for the
annual performance data for the Modernization Act (GPRAMA).
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 Administration for Community Living’s The proposed data collection tools
U.S.C. 3506(c)(2)(A)) requires Federal American Indian, Alaskan Natives and may be found on the ACL website for
agencies to provide a 60-day notice in Native Hawaiian Programs (OAA Title review at https://www.acl.gov/about-
the Federal Register concerning each VI) is a revision of a currently approved acl/public-input.
proposed collection of information, annual program performance data Estimated Program Burden: Title VI
including each proposed extension of an collection (OMB# 0985–0059). These funding is broken into three categories.
existing collection of information, data collection materials have been Parts A and B are for nutritional and
before submitting the collection to OMB updated to better align with comparable
supportive programming, and ask for
for approval. To comply with this data collected for ACL’s other
the same information. Part A is for
requirement, ACL is publishing a notice nutritional, supportive, and caregiving
American Indian and Alaska Native
of the proposed collection of grants. Proposed changes include
adding data components and updating grantees, and Part B is for Native
information set forth in this document. Hawaiian grantees. Part C is for
With respect to the following collection others for more accurate reporting of
persons served and activities provided caregiver programming. All Part C
of information, ACL invites comments
through the Title VI-funded programs. grantees must have Part A/B funding;
on our burden estimates or any other
aspect of this collection of information, The revised data collection will provide but not all Part A/B grantees will have
including: data necessary to determine the Part C programs. Therefore, there are
(1) Whether the proposed collection effectiveness of the program. Some 270 unique respondents, but only 237
of information is necessary for the examples of these changes are updating will have to complete all portions of the
proper performance of ACL’s functions, definitions in Title VI to be more in line PPR. ACL believes that the increase in
including whether the information will with Title III, asking for unduplicated burden hours is justified by the
have practical utility; numbers of people served for different improved quality of the data and will
(2) The accuracy of ACL’s estimate of services and the number of hours spent ultimately improve the services
the burden of the proposed collection of providing said services. Additionally, provided to Native Elders.
Responses
Number of Hours per Annual
Respondent/data collection activity per
respondents response burden hours
respondent
PPR Part A/B ................................................................................................... 270 1 1.83 494.1
PPR Part C ...................................................................................................... 237 1 1.66 393.4
Total: ......................................................................................................... ........................ ........................ ........................ 887.5
Dated: August 8, 2018. DEPARTMENT OF HEALTH AND announcing an opportunity for public
Mary Lazare, HUMAN SERVICES comment on the proposed collection of
Principal Deputy Administrator. certain information by the Agency.
Food and Drug Administration Under the Paperwork Reduction Act of
[FR Doc. 2018–17576 Filed 8–14–18; 8:45 am]
BILLING CODE 4154–01–P
1995 (PRA), Federal Agencies are
[Docket No. FDA–2011–N–0915] required to publish notice in the
Agency Information Collection Federal Register concerning each
Activities; Proposed Collection; proposed collection of information,
Comment Request; Guidance for including each proposed extension of an
Industry on Postmarketing Adverse existing collection of information, and
Event Reporting for Nonprescription to allow 60 days for public comment in
Human Drug Products Marketed response to the notice. This notice
solicits comments on the collection of
daltland on DSKBBV9HB2PROD with NOTICES
Without an Approved Application
information entitled ‘‘Guidance for
AGENCY: Food and Drug Administration, Industry on Postmarketing Adverse
HHS. Event Reporting for Nonprescription
ACTION: Notice. Human Drug Products Marketed
Without an Approved Application.’’
SUMMARY: The Food and Drug
Administration (FDA, Agency, or we) is
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![40522 Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices
of the FD&C Act (21 U.S.C. 379aa(b)(1)), of adverse drug experience reports approximately 283 respondents for
including followup reports under submitted for nonprescription drug nonprescription drugs marketed without
760(c)(2) of the FD&C Act (21 U.S.C. products marketed without an approved an approved application. We estimate
379aa(c)(2)), and how to submit these application and on prior input from that each submission will take
reports. The estimates for the annual comments received from prior Federal approximately 6 hours to prepare and
reporting and recordkeeping burdens Register publications. submit.
are based on FDA data on the number Based on FDA records, we received
194,449 total annual responses from
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of
Activity responses per annual burden per Total hours
respondents respondent responses response
Reports of serious adverse drug events (21 U.S.C.
379aa((b) and (c)) ............................................................ 283 687.099 194,449 6 1,166,694
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Section 760(e) of the FD&C Act (21 recommends that respondents maintain maintained by approximately 300
U.S.C. 379aa(e)) also requires that records of efforts to obtain the minimum respondents, and that it takes
responsible persons maintain records of data elements for a report of a serious approximately 8 hours to maintain each
nonprescription adverse event reports, adverse drug event and any followup record.
whether or not the event is serious, for reports. We estimate that there are
a period of 6 years. The guidance approximately 265,700 records per year
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Total Average
Number of
Activity records per annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
Recordkeeping (21 U.S.C. 379aa(e)(1)) .............................. 300 885.6667 265,700 8 2,125,600
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the and Clinical Pharmacology Advisory www.regulations.gov electronic filing
information collection reflects an Committee. The general function of the system will accept comments until
overall increase. We attribute this committee is to provide advice and midnight Eastern Time at the end of
adjustment to an increase in the number recommendations to FDA on regulatory September 19, 2018. Comments received
of submissions we received in the last issues. The meeting will be open to the by mail/hand delivery/courier (for
few years. public. FDA is establishing a docket for written/paper submissions) will be
Dated: August 9, 2018. public comment on this document. considered timely if they are
Leslie Kux, DATES: The meeting will be held on postmarked or the delivery service
September 20, 2018, from 8 a.m. to 5 acceptance receipt is on or before that
Associate Commissioner for Policy.
p.m. date.
[FR Doc. 2018–17526 Filed 8–14–18; 8:45 am]
Comments received on or before
BILLING CODE 4164–01–P ADDRESSES: FDA White Oak Campus, September 5, 2018, will be provided to
10903 New Hampshire Ave., Bldg. 31 the committee. Comments received after
Conference Center, the Great Room (Rm. that date will be taken into
DEPARTMENT OF HEALTH AND 1503), Silver Spring, MD 20993–0002. consideration by FDA.
HUMAN SERVICES Answers to commonly asked questions You may submit comments as
including information regarding special follows:
Food and Drug Administration
accommodations due to a disability,
[Docket No. FDA–2018–N–2944] visitor parking, and transportation may Electronic Submissions
be accessed at: https://www.fda.gov/ Submit electronic comments in the
Pharmaceutical Science and Clinical AdvisoryCommittees/AboutAdvisory following way:
Pharmacology Advisory Committee; Committees/ucm408555.htm. • Federal eRulemaking Portal:
Notice of Meeting; Establishment of a FDA is establishing a docket for https://www.regulations.gov. Follow the
Public Docket; Request for Comments public comment on this meeting. The instructions for submitting comments.
AGENCY: Food and Drug Administration, docket number is FDA–2018–N–2944. Comments submitted electronically,
HHS. The docket will close on September 19, including attachments, to https://
daltland on DSKBBV9HB2PROD with NOTICES
ACTION: Notice; establishment of a 2018. Submit either electronic or www.regulations.gov will be posted to
public docket; request for comments. written comments on this public the docket unchanged. Because your
meeting by September 19, 2018. Please comment will be made public, you are
SUMMARY: The Food and Drug note that late, untimely filed comments solely responsible for ensuring that your
Administration (FDA) announces a will not be considered. Electronic comment does not include any
forthcoming public advisory committee comments must be submitted on or confidential information that you or a
meeting of the Pharmaceutical Science before September 19, 2018. The https:// third party may not wish to be posted,
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Document Created: 2018-08-15 01:26:18
Document Modified: 2018-08-15 01:26:18
| 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 | Submit either electronic or written comments on the collection of information by October 15, 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 40520 |
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