80 FR 36543 - Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; 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 80, Issue 122 (June 25, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 122 (June 25, 2015)
| Page Range | 36543-36545 | |
| FR Document | 2015-15638 |
[Federal Register Volume 80, Number 122 (Thursday, June 25, 2015)] [Notices] [Pages 36543-36545] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-15638] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0915] Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; 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) 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 July 27, 2015. 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 oira_ [[Page 36544]] [email protected] All comments should be identified with the OMB control number 0910-0636. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [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. Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application (OMB Control Number 0910-0636)--Extension Respondents to this collection of information are manufacturers, packers, and distributors whose name (under section 502(b)(1) (21 U.S.C. 352(b)(1)) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)) appears on the label of a nonprescription drug marketed in the United States. 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) (21 U.S.C. 379aa(b)(1)) of the FD&C Act, including follow-up reports under 760(c)(2) (21 U.S.C. 379aa(c)(2)) of the FD&C Act, 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, including FDA's knowledge about the time needed to prepare the reports and to maintain records. In the Federal Register of January 23, 2015 (80 FR 3608), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment. The comment requested that we increase the reporting burden estimates from 2 hours to 6 hours and the recordkeeping burden estimates from 5 hours to 8 hours. The comment said although there may be circumstances where FDA's estimates for reporting and recordkeeping may be accurate, the comment contended that, in its experience, the approximations are underestimated. The comment said that as many as 6 hours may be required to complete a single serious adverse event report, especially when the sponsor's medical and quality review teams are involved, and that as many as 8 hours may be required to maintain all relevant records for a single adverse event report as stipulated by statute. FDA Response: We have reconsidered our estimates, and agree with the comment that there may be circumstances where 6 hours would be needed to prepare and submit a report to us and 8 hours may be needed for recordkeeping. We have revised our reporting and recordkeeping burden estimates accordingly. Based on FDA data, we estimate between 10,000 and 15,000 (i.e., approximately 12,500) total annual responses from approximately 50 respondents for nonprescription drugs marketed without an approved application, and we also 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 50 250 12,500 6 75,000 (c)).............................................................. -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Section 760(e) (21 U.S.C. 379aa(e) of the FD&C Act 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 document 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. We estimate that there are approximately 20,000 records per year maintained by approximately 200 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)).............................. 200 100 20,000 8 160,000 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 36545]] Therefore, the estimated annual reporting burden for this information is 25,000 hours and the estimated annual recordkeeping burden is 100,000 hours. Dated: June 22, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-15638 Filed 6-24-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 122 / Thursday, June 25, 2015 / Notices 36543
reporting on the overall performance of improvement in knowledge skills, will be provided to grantees to support
these grant programs. attitudes, and behaviors related to this data collection process.
Data will be collected from all 60 healthy marriage and responsible Respondents: Office of Family
Community-Centered Healthy Marriage, fatherhood. Grantees will be asked to Assistance Funded Community-
54 Pathways to Responsible Fatherhood input data for selected outcomes for
Centered Healthy Marriage, Pathways to
and 5 Community-Centered Responsible activities funded under the grants.
Responsible Fatherhood and
Fatherhood Ex-Prisoner Reentry Grantees will extract data from program
grantees in the OFA programs. Grantees records and will report the data twice Community-Centered Responsible
will report on program and participant yearly through an on-line data Fatherhood Ex-Prisoner Reentry
outcomes in such areas as participants’ collection tool. Training and assistance Grantees.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total annual
Instrument responses per burden hours
respondents burden hours
respondent per response
Performance measure reporting form (for private sector af-
fected public) ........................................................................ 110 2 0.8 176
Performance measure reporting form (for State, local, and
tribal government affected public) ........................................ 9 2 0.8 14
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND document, under Instructions, ‘‘Docket
Hours: 190 HUMAN SERVICES No. FDA–2013–N–1524’’ is corrected to
Additional Information: read ‘‘Docket No. FDA–2015–N–1196’’.
Food and Drug Administration Dated: June 18, 2015.
Copies of the proposed collection may
[Docket No. FDA–2015–N–1196] Leslie Kux,
be obtained by writing to the
Administration for Children and Associate Commissioner for Policy.
List of Bulk Drug Substances That May
Families, Office of Planning, Research [FR Doc. 2015–15558 Filed 6–24–15; 8:45 am]
Be Used by an Outsourcing Facility To
and Evaluation, 370 L’Enfant Compound Drugs for Use in Animals; BILLING CODE 4164–01–P
Promenade SW., Washington, DC 20447, Request for Nominations; Correction
Attn: ACF Reports Clearance Officer. All
AGENCY: Food and Drug Administration, DEPARTMENT OF HEALTH AND
requests should be identified by the title
HHS. HUMAN SERVICES
of the information collection. Email
address: infocollection@acf.hhs.gov. ACTION: Notice; correction.
Food and Drug Administration
OMB Comment: SUMMARY: The Food and Drug [Docket No. FDA–2011–N–0915]
OMB is required to make a decision Administration is correcting a notice
concerning the collection of information entitled ‘‘List of Bulk Drug Substances Agency Information Collection
That May Be Used by an Outsourcing Activities; Proposed Collection;
between 30 and 60 days after
Facility to Compound Drugs for Use in Submission for Office of Management
publication of this document in the
Animals; Request for Nominations’’ that and Budget Review; Guidance for
Federal Register. Therefore, a comment appeared in the Federal Register of May
is best assured of having its full effect Industry on Postmarketing Adverse
19, 2015 (80 FR 28622). The document Event Reporting for Nonprescription
if OMB receives it within 30 days of announced the intention to develop a
publication. Written comments and Human Drug Products Marketed
list of bulk drug substances that may be Without an Approved Application
recommendations for the proposed used by outsourcing facilities registered
information collection should be sent under the Federal Food, Drug, and AGENCY: Food and Drug Administration,
directly to the following: Office of Cosmetic Act (the FD&C Act) to HHS.
Management and Budget, Paperwork compound animal drugs, in accordance ACTION: Notice.
Reduction Project, Fax: 202–395–7285, with FDA’s draft guidance for industry
Email: OIRA_SUBMISSION@ #230, ‘‘Compounding Animal Drugs SUMMARY: The Food and Drug
OMB.EOP.GOV, Attn: Desk Officer for from Bulk Drug Substances.’’ The Administration (FDA) is announcing
document was published with an that a proposed collection of
the Administration for Children and
incorrect docket number. This information has been submitted to the
Families.
document corrects that error. Office of Management and Budget
Robert Sargis, FOR FURTHER INFORMATION CONTACT: Lisa
(OMB) for review and clearance under
Reports Clearance Officer. Granger, Office of Policy and Planning, the Paperwork Reduction Act of 1995.
[FR Doc. 2015–15547 Filed 6–24–15; 8:45 am] Food and Drug Administration, 10903 DATES: Fax written comments on the
New Hampshire Ave., Bldg. 32, rm. collection of information by July 27,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
BILLING CODE 4184–01–P
3330, Silver Spring, MD 20993–0002, 2015.
301–796–9115. ADDRESSES: To ensure that comments on
SUPPLEMENTARY INFORMATION: In the the information collection are received,
Federal Register of Tuesday, May 19, OMB recommends that written
2015, in FR Doc. 2015–11983, the comments be faxed to the Office of
following correction is made: Information and Regulatory Affairs,
1. On page 28622, in the second OMB, Attn: FDA Desk Officer, FAX:
column, in the ADDRESSES section of the 202–395–7285, or emailed to oira_
VerDate Sep<11>2014 16:37 Jun 24, 2015 Jkt 235001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\25JNN1.SGM 25JNN1](https://thefederalregister.org/doc/80_FR_36665/page/1.svg)
![Federal Register / Vol. 80, No. 122 / Thursday, June 25, 2015 / Notices 36545
Therefore, the estimated annual SUPPLEMENTARY INFORMATION: Under the experiencing some level of hearing loss.
reporting burden for this information is PRA (44 U.S.C. 3501–3520), Federal Moreover, much of the information in
25,000 hours and the estimated annual Agencies must obtain approval from the these ads is conveyed by voiceover,
recordkeeping burden is 100,000 hours. Office of Management and Budget meaning that the audio channel is the
Dated: June 22, 2015. (OMB) for each collection of only way to receive the information.
information they conduct or sponsor. Although people with serious hearing
Leslie Kux,
‘‘Collection of information’’ is defined loss may compensate by using closed
Associate Commissioner for Policy.
in 44 U.S.C. 3502(3) and 5 CFR captioning (which may or may not be
[FR Doc. 2015–15638 Filed 6–24–15; 8:45 am] 1320.3(c) and includes Agency requests available for ads) or hearing aids, some
BILLING CODE 4164–01–P or requirements that members of the individuals experience the effects of
public submit reports, keep records, or hearing loss without realizing that it is
provide information to a third party. the cause and others choose not to use
DEPARTMENT OF HEALTH AND Section 3506(c)(2)(A) of the PRA (44 external compensatory aids (Ref. 6). For
HUMAN SERVICES U.S.C. 3506(c)(2)(A)) requires Federal these reasons, FDA is proposing
Agencies to provide a 60-day notice in research to investigate how people at
Food and Drug Administration
the Federal Register concerning each various ages and levels of hearing ability
[Docket No. FDA–2015–N–2163]
proposed collection of information comprehend DTC ads.
before submitting the collection to OMB Sponsors of DTC ads cannot control
Agency Information Collection for approval. To comply with this the hearing abilities of their audiences.
Activities; Proposed Collection; requirement, FDA is publishing notice Nonetheless, researchers have identified
Comment Request; Hearing, Aging, of the proposed collection of several aspects of DTC ads within their
and Direct-to-Consumer Television information set forth in this document. control that influence the understanding
Advertisements With respect to the following of speech in individuals who experience
collection of information, FDA invites aging-related hearing loss. First,
AGENCY: Food and Drug Administration, comments on these topics: (1) Whether frequency thresholds differ as people
HHS. the proposed collection of information age; older adults are not able to hear
ACTION: Notice. is necessary for the proper performance higher frequencies as well (Ref. 7 and 8).
of FDA’s functions, including whether Second, DTC television ads contain a
SUMMARY: The Food and Drug the information will have practical risk statement of the most serious and
Administration (FDA) is announcing an utility; (2) the accuracy of FDA’s most common side effects, called ‘‘the
opportunity for public comment on the estimate of the burden of the proposed major statement’’. FDA regulations
proposed collection of certain collection of information, including the require that the major statement must be
information by the Agency. Under the validity of the methodology and included in at least the audio portion of
Paperwork Reduction Act of 1995 (the assumptions used; (3) ways to enhance the ad (Ref. 9). The risks of a medical
PRA), Federal Agencies are required to the quality, utility, and clarity of the product often include highly technical
publish notice in the Federal Register information to be collected; and (4) medical terms that must be transformed
concerning each proposed collection of ways to minimize the burden of the into consumer-friendly language to
information and to allow 60 days for collection of information on convey the risks appropriately. This is
public comment in response to the respondents, including through the use easier in some cases than in others. In
notice. This notice solicits comments on of automated collection techniques, addition, there are techniques to help
research entitled, ‘‘Hearing, Aging, and when appropriate, and other forms of reduce the complexity of the major
Direct-to-Consumer Television information technology. statement, such as maintaining active
Advertisements’’. This study will voice, reducing instances where words
Hearing, Aging, and Direct-to-
examine how changes to hearing across need clarification from other later words
Consumer Television Advertisements—
the lifespan affect the comprehension of in the broadcast, and using shorter
(OMB Control Number 0910–NEW)
direct-to-consumer (DTC) television sentences. Third, television ad spots are
advertisements for prescription drugs. Section 1701(a)(4) of the Public typically bought in increments of 15
Health Service Act (42 U.S.C. seconds, leading to many 30- and 60-
DATES: Submit either electronic or
300u(a)(4)) authorizes the FDA to second ads, and some 75-second ads
written comments on the collection of
conduct research relating to health when risk information is especially
information by August 24, 2015.
information. Section 1003(d)(2)(C) of the dense. In order to fit the required
ADDRESSES: Submit electronic Federal Food, Drug, and Cosmetic Act information into this time frame, the
comments on the collection of (21 U.S.C. 393(b)(2)(c)) authorizes FDA audio presentation speed may be
information to http:// to conduct research relating to drugs adjusted to be faster or slower. Research
www.regulations.gov. Submit written and other FDA regulated products in has shown that fast speech is more
comments on the collection of carrying out the provisions of the FD&C difficult to understand than slower
information to the Division of Dockets Act. speech, even for healthy young adults
Management (HFA–305), Food and Drug Older adults use a disproportionate (Ref. 10).
Administration, 5630 Fishers Lane, Rm. number of prescription drugs (Ref. 1) Thus, we propose to examine the
1061, Rockville, MD 20852. All and watch more television than other effects of three aspects of DTC ads
comments should be identified with the age groups (Ref. 2). Age-related changes (voice frequency, complexity of major
asabaliauskas on DSK5VPTVN1PROD with NOTICES
docket number found in brackets in the in hearing are common (Ref. 3, 4, and statement, speed of major statement) on
heading of this document. 5) and, depending on their severity, the comprehension of the ads among
FOR FURTHER INFORMATION CONTACT: FDA influence the understanding of speech. four different age groups of individuals.
PRA Staff, Office of Operations, Food DTC television advertisements (ads) Because hearing losses begin to occur as
and Drug Administration, 8455 contain large amounts of complex people age, we will examine a group of
Colesville Rd., COLE–14526, Silver information about prescription drug middle-aged adults (40–50 years),
Spring, MD 20993–0002, PRAStaff@ treatments that may be particularly young-old adults (60–75 years), and old-
fda.hhs.gov. relevant to a population that is old adults (75+ years), and a group of
VerDate Sep<11>2014 16:37 Jun 24, 2015 Jkt 235001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\25JNN1.SGM 25JNN1](https://thefederalregister.org/doc/80_FR_36665/page/3.svg)
Document Created: 2015-12-15 14:17:02
Document Modified: 2015-12-15 14:17:02
| 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 July 27, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 36543 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR