80 FR 42502 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 137 (July 17, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 137 (July 17, 2015)
| Page Range | 42502-42503 | |
| FR Document | 2015-17558 |
[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)] [Notices] [Pages 42502-42503] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-17558] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0429 (formerly Docket No. 2007D-0496)] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 certain labeling statements for nonprescription human drug products marketed without an approved application. DATES: Submit either electronic or written comments on the collection of information by September 15, 2015. ADDRESSES: Submit electronic comments on the collection of [[Page 42503]] information via the internet at http://www.regulations.gov. Submit written comments on the collection of information to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the 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: 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: (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 Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act OMB Control Number 0910-0641--Extension Section 502(x) of the FD&C Act (21 U.S.C. 352(x)), which was added by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109-462), requires the label of a nonprescription drug product marketed without an approved application in the United States to include a domestic address or domestic telephone number through which a manufacturer, packer, and distributor may receive a report of a serious adverse event associated with the product. The guidance document contains questions and answers relating to this labeling requirement and provides guidance to industry on the following topics: (1) The meaning of ``domestic address'' for purposes of the labeling requirements of section 502(x) of the FD&C Act; (2) FDA's recommendation for the use of an introductory statement before the domestic address or phone number that is required to appear on the product label under section 502(x) of the FD&C Act; and (3) FDA's intent regarding enforcing the labeling requirements of section 502(x) of the FD&C Act. Description of Respondents: Respondents to this collection of information are manufacturers, packers, and distributors whose name (pursuant to section 502(b)(1) of the FD&C Act) appears on the label of a nonprescription drug product marketed in the United States without an approved application. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Third-Party Disclosure Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of disclosures per Total annual Average burden Total hours respondents respondent disclosures per disclosure -------------------------------------------------------------------------------------------------------------------------------------------------------- Including a domestic address or phone number and a statement of its 300 3 900 4 3,600 purpose on OTC drug labeling (21 U.S.C. 502(x))................... -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: July 10, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-17558 Filed 7-16-15; 8:45 am] BILLING CODE 4164-01-P
![42502 Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices
to assist sponsors developing drugs to If a concerning nonclinical signal is docket number found in brackets in the
identify nonclinical signals of testicular identified, the draft guidance presents heading of this document. Received
toxicity and to evaluate the potential for suggestions for clinical monitoring comments may be seen in the Division
such toxicity in humans. when the drug is initially administered of Dockets Management between 9 a.m.
DATES: Although you can comment on to humans. These suggestions aim to and 4 p.m., Monday through Friday, and
any guidance at any time (see 21 CFR minimize the hazards to men while will be posted to the docket at http://
10.115(g)(5)), to ensure that the Agency making possible the collection of data www.regulations.gov.
considers your comment on this draft that will assist in evaluating the
potential toxicity of the drug in the IV. Electronic Access
guidance before it begins work on the
final version of the guidance, submit target population. These early studies, Persons with access to the Internet
either electronic or written comments however, are not intended to be a may obtain the document at either
on the draft guidance by October 15, definitive evaluation of the potential for http://www.fda.gov/Drugs/
2015. testicular toxicity of the drug. Rather, GuidanceCompliance
they can provide clinical information RegulatoryInformation/Guidances/
ADDRESSES: Submit written requests for
that, together with the nonclinical default.htm or http://
single copies of the draft guidance to the
information, will support a judgment as www.regulations.gov.
Division of Drug Information, Center for
to whether the testicular toxicity signal Dated: July 13, 2015.
Drug Evaluation and Research, Food
warrants indepth evaluation in a
and Drug Administration, 10001 New Leslie Kux,
dedicated safety study.
Hampshire Ave., Hillandale Building, If a reasonable basis for concern of Associate Commissioner for Policy.
4th Floor, Silver Spring, MD 20993– human testicular toxicity exists, a [FR Doc. 2015–17557 Filed 7–16–15; 8:45 am]
0002. Send one self-addressed adhesive dedicated clinical safety trial with a BILLING CODE 4164–01–P
label to assist that office in processing primary objective of evaluating drug-
your requests. See the SUPPLEMENTARY related testicular toxicity may be
INFORMATION section for electronic warranted. The draft guidance provides DEPARTMENT OF HEALTH AND
access to the draft guidance document. recommendations for the design of such HUMAN SERVICES
Submit electronic comments on the a trial, including conduct, endpoints,
draft guidance to http:// Food and Drug Administration
and presentation of results. These are
www.regulations.gov. Submit written general recommendations for the [Docket No. FDA–2007–D–0429 (formerly
comments to the Division of Dockets purpose of defining the role of drugs in Docket No. 2007D–0496)]
Management (HFA–305), Food and Drug testicular injury; however, the specific
Administration, 5630 Fishers Lane, Rm. details of an individual trial may vary Agency Information Collection
1061, Rockville, MD 20852. depending on the context of use of the Activities; Proposed Collection;
FOR FURTHER INFORMATION CONTACT: drug product. Comment Request; Guidance for
Eufrecina Deguia, Center for Drug This draft guidance is being issued Industry on Questions and Answers
Evaluation and Research, Food and consistent with FDA’s good guidance Regarding the Labeling of
Drug Administration, 10903 New practices regulation (21 CFR 10.115). Nonprescription Human Drug Products
Hampshire Ave., Bldg. 22, Rm. 5348, The draft guidance, when finalized, will Marketed Without an Approved
Silver Spring, MD 20993–0002, 301– represent the current thinking of FDA Application as Required by the Dietary
796–0881. on the evaluation of testicular toxicity Supplement and Nonprescription Drug
SUPPLEMENTARY INFORMATION: during drug development. It does not Consumer Protection Act
I. Background establish rights for any person and is not AGENCY: Food and Drug Administration,
binding on FDA or the public. You can HHS.
FDA is announcing the availability of use an alternative approach if it satisfies
a draft guidance for industry entitled ACTION: Notice.
the requirements of the applicable
‘‘Testicular Toxicity: Evaluation During statutes and regulations. SUMMARY: The Food and Drug
Drug Development.’’ This draft guidance Administration (FDA) is announcing an
is intended to help sponsors identify II. The Paperwork Reduction Act of
1995 opportunity for public comment on the
nonclinical signals that raise concern proposed collection of certain
regarding the potential for human This draft guidance refers to information by the Agency. Under the
testicular toxicity and to evaluate those previously approved collections of Paperwork Reduction Act of 1995 (the
signals appropriately in human studies. information found in FDA regulations. PRA), Federal Agencies are required to
The draft guidance describes the These collections of information are publish notice in the Federal Register
standard battery of nonclinical studies subject to review by the Office of concerning each proposed collection of
that are used to assess the effects of Management and Budget (OMB) under information, including each proposed
pharmaceuticals on the male the Paperwork Reduction Act of 1995 extension of an existing collection of
reproductive system. The draft guidance (44 U.S.C. 3501–3520). The collections information, and to allow 60 days for
discusses findings in nonclinical studies of information in 21 CFR part 312 have public comment in response to the
that may increase the level of concern been approved under OMB control notice. This notice solicits comments on
for drug-related testicular toxicity. number 0910–0014. certain labeling statements for
Examples of nonclinical studies that
III. Comments nonprescription human drug products
could be used to further evaluate initial
srobinson on DSK5SPTVN1PROD with NOTICES
marketed without an approved
signals of testicular toxicity are also Interested persons may submit either
application.
described. The draft guidance then electronic comments regarding this
provides a general approach on how to document to http://www.regulations.gov DATES: Submit either electronic or
weigh the relevance of nonclinical or written comments to the Division of written comments on the collection of
findings, taking into account factors that Dockets Management (see ADDRESSES). It information by September 15, 2015.
can confound the interpretation of these is only necessary to send one set of ADDRESSES: Submit electronic
findings. comments. Identify comments with the comments on the collection of
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![Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices 42503
information via the internet at http:// for approval. To comply with this Protection Act (Pub. L. 109–462),
www.regulations.gov. Submit written requirement, FDA is publishing notice requires the label of a nonprescription
comments on the collection of of the proposed collection of drug product marketed without an
information to the Dockets Management information set forth in this document. approved application in the United
Branch (HFA–305), Food and Drug With respect to the following States to include a domestic address or
Administration, 5630 Fishers Lane, Rm. collection of information, FDA invites domestic telephone number through
1061, Rockville, MD 20852. All comments on: (1) Whether the proposed which a manufacturer, packer, and
comments should be identified with the collection of information is necessary distributor may receive a report of a
docket number found in brackets in the for the proper performance of FDA’s serious adverse event associated with
heading of this document. functions, including whether the the product. The guidance document
information will have practical utility; contains questions and answers relating
FOR FURTHER INFORMATION CONTACT: FDA (2) the accuracy of FDA’s estimate of the
PRA Staff, Office of Operations, Food to this labeling requirement and
burden of the proposed collection of provides guidance to industry on the
and Drug Administration, 8455 information, including the validity of
Colesville Rd., COLE–14526, Silver following topics: (1) The meaning of
the methodology and assumptions used; ‘‘domestic address’’ for purposes of the
Spring, MD 20993–0002, PRAStaff@ (3) ways to enhance the quality, utility,
fda.hhs.gov. labeling requirements of section 502(x)
and clarity of the information to be of the FD&C Act; (2) FDA’s
SUPPLEMENTARY INFORMATION: Under the collected; and (4) ways to minimize the recommendation for the use of an
PRA (44 U.S.C. 3501–3520), Federal burden of the collection of information introductory statement before the
Agencies must obtain approval from the on respondents, including through the domestic address or phone number that
Office of Management and Budget use of automated collection techniques,
is required to appear on the product
(OMB) for each collection of when appropriate, and other forms of
label under section 502(x) of the FD&C
information they conduct or sponsor. information technology.
Act; and (3) FDA’s intent regarding
‘‘Collection of information’’ is defined Guidance for Industry on Questions enforcing the labeling requirements of
in 44 U.S.C. 3502(3) and 5 CFR and Answers Regarding the Labeling of section 502(x) of the FD&C Act.
1320.3(c) and includes Agency requests Nonprescription Human Drug Products
or requirements that members of the Description of Respondents:
Marketed Without an Approved Respondents to this collection of
public submit reports, keep records, or Application as Required by the Dietary
provide information to a third party. information are manufacturers, packers,
Supplement and Nonprescription Drug and distributors whose name (pursuant
Section 3506(c)(2)(A) of the PRA (44 Consumer Protection Act
U.S.C. 3506(c)(2)(A)) requires Federal to section 502(b)(1) of the FD&C Act)
Agencies to provide a 60-day notice in OMB Control Number 0910–0641— appears on the label of a
the Federal Register concerning each Extension nonprescription drug product marketed
proposed collection of information, Section 502(x) of the FD&C Act (21 in the United States without an
including each proposed extension of an U.S.C. 352(x)), which was added by the approved application.
existing collection of information, Dietary Supplement and FDA estimates the burden of this
before submitting the collection to OMB Nonprescription Drug Consumer collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number disclosures Total annual
Activity burden per Total hours
of respondents per disclosures disclosure
respondent
Including a domestic address or phone number and a
statement of its purpose on OTC drug labeling (21
U.S.C. 502(x)) .................................................................. 300 3 900 4 3,600
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 10, 2015. DEPARTMENT OF HEALTH AND Patient-Focused Drug Development for
Leslie Kux, HUMAN SERVICES Huntington’s disease and Parkinson’s
Associate Commissioner for Policy. disease. Patient-Focused Drug
Food and Drug Administration Development is part of FDA’s
[FR Doc. 2015–17558 Filed 7–16–15; 8:45 am]
BILLING CODE 4164–01–P [Docket No. FDA–2012–N–0967] performance commitments made as part
of the fifth authorization of the
Public Meeting on Patient-Focused Prescription Drug User Fee Act (PDUFA
Drug Development for Huntington’s V). The public meeting is intended to
and Parkinson’s Diseases allow FDA to obtain patient
AGENCY: Food and Drug Administration, perspectives on the impact of
Huntington’s disease and Parkinson’s
srobinson on DSK5SPTVN1PROD with NOTICES
HHS.
disease on daily life and patient views
ACTION: Notice of public meeting;
on treatment approaches. Although
request for comments.
these are both neurological diseases,
SUMMARY: The Food and Drug since they are quite distinct, FDA will
Administration (FDA or Agency) is structure this public meeting into two
announcing a public meeting and an distinct sessions. The morning session,
opportunity for public comment on scheduled from 9 a.m. to 1 p.m., will be
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Document Created: 2018-02-23 09:21:51
Document Modified: 2018-02-23 09:21:51
| 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 September 15, 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 42502 |
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