81_FR_8540 81 FR 8507 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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

81 FR 8507 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 81, Issue 33 (February 19, 2016)

Page Range8507-8508
FR Document2016-03457

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 (the PRA).

Federal Register, Volume 81 Issue 33 (Friday, February 19, 2016) 
[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Pages 8507-8508]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-03457]


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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; Submission for Office 
of Management and Budget Review; 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.

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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 (the PRA).

DATES: Fax written comments on the collection of information by March 
21, 2016.

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 [email protected]. All 
comments should be identified with the title. 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 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 
(issued in 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.
    In the Federal Register of July 17, 2015 (80 FR 42502), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment. However, these 
comments did not address the information collection.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 8508]]



                                               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: February 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03457 Filed 2-18-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices 8507 collection, FDA is conservatively over 20 years implementing the warning the past several years, FDA believes the estimating the total number of annual plan requirements and taking into estimate of 60 hours to complete an respondents to this collection of account increased computerization and initial rotational plan continues to be information to be 100. improvements in electronic reasonable. When the FTC requested an extension communication, the FTC estimated FDA estimates the burden of this of their approved warning plan submitting an initial plan would take 60 collection of information as follows: information collection in 2007, based on hours. Based on FDA’s experience over TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Numbers of Average Numbers of Total annual Total capital Activity responses per burden per Total hours respondents responses costs respondent response Submission of rotational plans for health warning statements .............................. 100 1 100 60 6,000 $1,200 1 There are no operating and maintenance costs associated with this collection of information. FDA estimates a total of 100 that a proposed collection of Protection Act (Pub. L. 109–462), respondents will respond to this information has been submitted to the requires the label of a nonprescription collection of information and take 60 Office of Management and Budget drug product marketed without an hours to complete a rotational warning (OMB) for review and clearance under approved application in the United plan for a total of 6,000 burden hours. the Paperwork Reduction Act of 1995 States to include a domestic address or In addition, capital costs are based on (the PRA). domestic telephone number through 100 respondents mailing in their DATES: Fax written comments on the which a manufacturer, packer, and submission at a postage rate of $12 for collection of information by March 21, distributor may receive a report of a a 5-pound parcel (business parcel post 2016. serious adverse event associated with mail delivered from the furthest the product. The guidance document ADDRESSES: To ensure that comments on delivery zone). Therefore, FDA contains questions and answers relating the information collection are received, estimates that the total postage cost for to this labeling requirement and OMB recommends that written mailing the rotational warning plans to provides guidance to industry on the comments be faxed to the Office of FDA to be $1,200. following topics: (1) The meaning of Information and Regulatory Affairs, Dated: February 12, 2016. OMB, Attn: FDA Desk Officer, FAX: ‘‘domestic address’’ for purposes of the Leslie Kux, 202–395–7285, or emailed to oira_ labeling requirements of section 502(x) Associate Commissioner for Policy. submission@omb.eop.gov. All of the FD&C Act; (2) FDA’s [FR Doc. 2016–03478 Filed 2–18–16; 8:45 am] comments should be identified with the recommendation for the use of an title. Also include the FDA docket introductory statement before the BILLING CODE 4164–01–P number found in brackets in the domestic address or phone number that heading of this document. is required to appear on the product DEPARTMENT OF HEALTH AND label under section 502(x) of the FD&C FOR FURTHER INFORMATION CONTACT: FDA HUMAN SERVICES Act; and (3) FDA’s intent regarding PRA Staff, Office of Operations, Food enforcing the labeling requirements of and Drug Administration, 8455 Food and Drug Administration section 502(x) of the FD&C Act. Colesville Rd., COLE–14526, Silver [Docket No. FDA–2007–D–0429 (formerly Spring, MD 20993–0002, PRAStaff@ Description of Respondents: Docket No. 2007D–0496)] fda.hhs.gov. Respondents to this collection of information are manufacturers, packers, SUPPLEMENTARY INFORMATION: In Agency Information Collection and distributors whose name (issued in compliance with 44 U.S.C. 3507, FDA Activities; Submission for Office of section 502(b)(1) of the FD&C Act) has submitted the following proposed Management and Budget Review; appears on the label of a collection of information to OMB for Comment Request; Guidance for nonprescription drug product marketed review and clearance. Industry on Questions and Answers in the United States without an Regarding the Labeling of Guidance for Industry on Questions approved application. Nonprescription Human Drug Products and Answers Regarding the Labeling of In the Federal Register of July 17, Marketed Without an Approved Nonprescription Human Drug Products 2015 (80 FR 42502), FDA published a Application as Required by the Dietary Marketed Without an Approved 60-day notice requesting public Supplement and Nonprescription Drug Application as Required by the Dietary comment on the proposed collection of Consumer Protection Act Supplement and Nonprescription Drug information. FDA received one Consumer Protection Act; OMB Control asabaliauskas on DSK5VPTVN1PROD with NOTICES AGENCY: Food and Drug Administration, comment. However, these comments Number 0910–0641—Extension HHS. did not address the information Section 502(x) of the FD&C Act (21 collection. ACTION: Notice. U.S.C. 352(x)), which was added by the FDA estimates the burden of this SUMMARY: The Food and Drug Dietary Supplement and collection of information as follows: Administration (FDA) is announcing Nonprescription Drug Consumer VerDate Sep<11>2014 17:59 Feb 18, 2016 Jkt 238001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\19FEN1.SGM 19FEN1

8508 Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of Average Number of disclosures Total annual Activity burden per Total hours 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: February 12, 2016. be accessed at: http:// committee meeting to be held on Leslie Kux, doubletree3.hilton.com/en/hotels/ September 15 and 16, 2016, on the FDA Associate Commissioner for Policy. maryland/doubletree-by-hilton-hotel- White Oak Campus, 10903 New [FR Doc. 2016–03457 Filed 2–18–16; 8:45 am] washington-dc-silver-spring-DCASSDT/ Hampshire Ave., Building 31 BILLING CODE 4164–01–P index.html. Conference Center, the Great Room (rm. Contact Person: Marieann Brill, Office 1503), Silver Spring, MD 20993–0002. of the Commissioner, Food and Drug Following the presentation on the DEPARTMENT OF HEALTH AND Administration, 10903 New Hampshire proposed framework for the September HUMAN SERVICES Ave., Bldg. 32, rm. 5154, Silver Spring, meeting, there will be an hour of open MD 20993, 240–402–3838, email: public hearing from 9:30 a.m. to 10:30 Food and Drug Administration marieann.brill@fda.hhs.gov, or FDA a.m. to provide an opportunity for the Advisory Committee Information Line, public to provide input concerning the [Docket No. FDA–2016–N–0567] 1–800–741–8138 (301–443–0572 in the topics before the PAC, including the use Pediatric Advisory Committee; Notice Washington, DC area). A notice in the of opioids for control of severe pain in of Meeting Federal Register about last minute the pediatric population. To assist with modifications that impact a previously the planning of this advisory committee AGENCY: Food and Drug Administration, announced advisory committee meeting meeting, FDA is establishing a public HHS. cannot always be published quickly docket [Docket No. FDA–2016–N–0584] ACTION: Notice; request for comments. enough to provide timely notice. to receive input on appropriate pediatric Therefore, you should always check the development plans for prescription This notice announces a forthcoming Agency’s Web site at http:// opioid drugs. The docket will remain meeting of a public advisory committee www.fda.gov/AdvisoryCommittees/ open following the September advisory of the Food and Drug Administration default.htm and scroll down to the committee meeting. Comments about (FDA). The meeting will be open to the appropriate advisory committee meeting the upcoming September advisory public. link, or call the advisory committee committee meeting should not be Name of Committee: Pediatric information line to learn about possible submitted to the docket number listed at Advisory Committee. modifications before coming to the the top of this Federal Register notice General Function of the Committee: meeting. [Docket No. FDA–2016–N–0567]. Please To provide advice and Agenda: On April 12, 2016, the also see the ADDRESSES section of this recommendations to the Agency on Pediatric Advisory Committee (PAC) notice for further docket information. FDA’s regulatory issues. will meet to discuss pediatric-focused The pediatric-focused safety reviews Date and Time: The meeting will be safety reviews, as mandated by the Best for the Centers will then occur. The PAC held on April 12, 2016, from 8 a.m. to Pharmaceuticals for Children Act (Pub. will meet to discuss the following 5:30 p.m. L. 107–109) and the Pediatric Research products (listed by FDA Center): ADDRESSES: FDA is establishing a public Equity Act (Pub. L. 108–155). See the • Center for Biologics Evaluation and docket [Docket No. FDA–2016–N–0567] list of the products in this document to Research (CBER): to receive input on pediatric-focused be discussed. Æ FLULAVAL QUADRIVALENT safety reviews and appropriate pediatric In addition, FDA will be providing (influenza virus vaccine) development plans for prescription information on a proposed public Æ FLULAVAL TRIVALENT (influenza opioid drugs. Comments about the advisory committee meeting for virus vaccine) upcoming September advisory September 15 and 16, 2016, on Æ FLUZONE QUADRIVALENT committee meeting should not be appropriate pediatric development (influenza virus vaccine) submitted to the docket number listed at plans for prescription opioid drugs. • Center for Drug Evaluation and the top of this Federal Register notice Prior to the safety reviews and the open Research (CDER): [Docket No. FDA–2016–N–0567], which public hearing (see later in this section Æ ACIPHEX SPRINKLES (rabeprazole is to provide an opportunity for the for further information), FDA will sodium) public to provide input concerning the present, from approximately 8:30 to 9:30 Æ SKYLA (levonorgestrel-releasing products before the Committee on April a.m., a framework of current plans for a intrauterine system) asabaliauskas on DSK5VPTVN1PROD with NOTICES 12, 2016. 2-day joint meeting of the PAC, the Æ MYCAMINE (micafungin sodium) Location: Double Tree by Hilton Anesthetic and Analgesic Drug Products Æ NOXAFIL (posaconazole) Hotel, 8727 Colesville Rd., Silver Advisory Committee, and the Drug Æ PRECEDEX (dexmedetomidine Spring, MD 20910, 301–589–5200. Safety and Risk Management Advisory hydrocholoride) Answers to commonly asked questions Committees. Æ SABRIL (vigabatrim) including information regarding special Elsewhere in this issue of the Federal Æ SEROQUEL (quetiapine fumarate) accommodations due to a disability, Register, FDA is publishing an and SEROQUEL XR (quetiapine visitor parking, and transportation may announcement of this advisory fumarate extended-release) VerDate Sep<11>2014 17:59 Feb 18, 2016 Jkt 238001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\19FEN1.SGM 19FEN1


Document Created: 2018-02-02 14:32:04
Document Modified: 2018-02-02 14:32:04
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by March 21, 2016.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation81 FR 8507 
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