81 FR 8505 - Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 33 (February 19, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 33 (February 19, 2016)
| Page Range | 8505-8507 | |
| FR Document | 2016-03478 |
[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)] [Notices] [Pages 8505-8507] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03478] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0190] Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control 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 submission of rotational plans for health warning label statements for smokeless tobacco products. DATES: Submit either electronic or written comments on the collection of information by April 19, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 [[Page 8506]] 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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2013-N-0190 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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 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. Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act (OMB Control Number 0910-0671)-Extension The Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) was enacted on June 22, 2009, amending the Federal Food, Drug, and Cosmetic Act (FD&C Act) and providing FDA with the authority to regulate tobacco products (Pub. L. 111-31; 123 Stat. 1776). Section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (the Smokeless Tobacco Act) (15 U.S.C. 4402), as amended by section 204 of the Tobacco Control Act, requires, among other things, that all smokeless tobacco product packages and advertisements bear one of four required warning statements. Section 3(b)(3)(A) of the Smokeless Tobacco Act requires that the warnings be displayed on packaging and advertising for each brand of smokeless tobacco ``in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer'' to, and approved by, FDA. This information collection--the submission to FDA of warning plans for smokeless tobacco products--is statutorily mandated. The warning plans will be reviewed by FDA, as required by the Smokeless Tobacco Act, to determine whether the companies' plans for the equal distribution and display of warning statements on packaging and the quarterly rotation of warning statements in advertising for each brand of smokeless tobacco products comply with section 3 of the Smokeless Tobacco Act, as amended. Based on the Federal Trade Commission's (FTC's) previous experience with the submission of warning plans and FDA's experience, FDA estimates that there are 52 companies affected by this information collection. To account for the entry of new smokeless tobacco companies that may be affected by this information [[Page 8507]] collection, FDA is conservatively estimating the total number of annual respondents to this collection of information to be 100. When the FTC requested an extension of their approved warning plan information collection in 2007, based on over 20 years implementing the warning plan requirements and taking into account increased computerization and improvements in electronic communication, the FTC estimated submitting an initial plan would take 60 hours. Based on FDA's experience over the past several years, FDA believes the estimate of 60 hours to complete an initial rotational plan continues to be reasonable. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Numbers of Activity Numbers of responses per Total annual Average burden Total hours Total capital respondents respondent responses per response costs -------------------------------------------------------------------------------------------------------------------------------------------------------- Submission of rotational plans for health warning 100 1 100 60 6,000 $1,200 statements....................................... -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no operating and maintenance costs associated with this collection of information. FDA estimates a total of 100 respondents will respond to this collection of information and take 60 hours to complete a rotational warning plan for a total of 6,000 burden hours. In addition, capital costs are based on 100 respondents mailing in their submission at a postage rate of $12 for a 5-pound parcel (business parcel post mail delivered from the furthest delivery zone). Therefore, FDA estimates that the total postage cost for mailing the rotational warning plans to FDA to be $1,200. Dated: February 12, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-03478 Filed 2-18-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices 8505
viruses in the manufacturing process for an area with active transmission of III. Electronic Access
such plasma-derived products. ZIKV; defer for 4 weeks after the last Persons with access to the Internet
ZIKV is an arbovirus from the sexual contact a donor who has had may obtain the guidance at either
Flaviviridae family, genus Flavivirus. It sexual contact with a man who has been http://www.fda.gov/BiologicsBlood
is transmitted to humans primarily by diagnosed with ZIKV or who traveled to Vaccines/GuidanceCompliance
the Aedes aegypti mosquito, but it may or resided in an area with active RegulatoryInformation/Guidances/
also be transmitted by the Aedes transmission of ZIKV in the 3 months default.htm or http://
albopictus mosquito. In addition, prior to that instance of sexual contact; www.regulations.gov.
intrauterine, perinatal, and sexual and defer for 4 weeks from the date of
transmission of ZIKV has been reported. Dated: February 12, 2016.
his or her departure, a donor who has
Two instances of possible transfusion- been a resident of or has travelled to an Leslie Kux,
transmission of ZIKV in Brazil have area with active transmission of ZIKV. Associate Commissioner for Policy.
been described in media [FR Doc. 2016–03393 Filed 2–18–16; 8:45 am]
announcements. For areas with active transmission of
BILLING CODE 4164–01–P
The most common ZIKV disease ZIKV, the guidance recommends that
symptoms include fever, arthralgia, blood collection establishments obtain
maculopapular rash, and conjunctivitis. blood and blood components from areas DEPARTMENT OF HEALTH AND
Neurological manifestations and of the United States without active HUMAN SERVICES
congenital anomalies have been transmission of ZIKV to fulfill orders.
associated with ZIKV disease outbreaks. However, a blood establishment may Food and Drug Administration
Association of ZIKV infection with collect platelets and plasma locally if
[Docket No. FDA–2013–N–0190]
Guillain-Barré syndrome cases has been the blood establishment implements
reported during outbreaks in Polynesia FDA-approved pathogen reduction Agency Information Collection
and in Brazil. In Brazil there has also technology for platelets and plasma. Activities; Proposed Collection;
been a marked increase in the incidence Further, blood establishments in areas Comment Request; Requirements
of microcephaly in regions most affected of active transmission may collect blood Under the Comprehensive Smokeless
by the ZIKV epidemic. components locally provided the Tobacco Health Education Act of 1986,
ZIKV reached the Americas in early establishment tests blood donations as Amended by the Family Smoking
2015 with local transmission first with an FDA-licensed blood donor Prevention and Tobacco Control Act
reported in Brazil and as of February 10, screening test for ZIKV, when such a
2016, there are 30 countries and test becomes available. AGENCY: Food and Drug Administration,
territories worldwide with active local HHS.
This guidance is being issued
transmission of the virus. As of consistent with FDA’s good guidance ACTION: Notice.
February 10, 2016, local mosquito-borne practices regulation (21 CFR 10.115).
transmission of ZIKV has not been SUMMARY: The Food and Drug
FDA is issuing this guidance for Administration (FDA) is announcing an
reported in the continental United
immediate implementation in opportunity for public comment on the
States, but cases have been reported in
accordance with 21 CFR 10.115(g)(2) proposed collection of certain
travelers returning to the United States
without initially seeking prior comment information by the Agency. Under the
from areas with local transmission.
Consistent with existing regulations because the Agency has determined that Paperwork Reduction Act of 1995 (the
and applicable guidance, donors must prior public participation is not feasible PRA), Federal Agencies are required to
be in good health at the time of donation or appropriate. The guidance represents publish notice in the Federal Register
§ 640.3(b) (21 CFR 640.3(b)) as indicated the current thinking of FDA on concerning each proposed collection of
by, among other things, freedom from ‘‘Recommendations for Donor information, including each proposed
any disease transmissible by blood Screening, Deferral, and Product extension of an existing collection of
transfusion, as can be determined by Management to Reduce the Risk of information, and to allow 60 days for
history and examination (§ 640.3(b)(6)). Transfusion-Transmission of Zika public comment in response to the
Standard operating procedures that are Virus.’’ It does not establish any rights notice. This notice solicits comments on
already in place should result in the for any person and is not binding on submission of rotational plans for health
deferral of individuals who have FDA or the public. You can use an warning label statements for smokeless
symptoms consistent with ZIKV alternative approach if it satisfies the tobacco products.
infection at the time of donation. The requirements of the applicable statutes DATES: Submit either electronic or
recommendations in the guidance are and regulations. written comments on the collection of
intended to reduce the risk of collecting II. Paperwork Reduction Act of 1995 information by April 19, 2016.
blood and blood components from at- ADDRESSES: You may submit comments
risk donors who could be potentially This guidance refers to previously as follows:
infected with ZIKV and do not display approved collections of information
clinical symptoms during the found in FDA regulations. These Electronic Submissions
incubation period or have an collections of information are subject to Submit electronic comments in the
asymptomatic infection. review by the Office of Management and following way:
The guidance recommends that blood Budget (OMB) under the Paperwork • Federal eRulemaking Portal: http://
asabaliauskas on DSK5VPTVN1PROD with NOTICES
collection establishments in areas Reduction Act of 1995 (44 U.S.C. 3501– www.regulations.gov. Follow the
without active transmission of ZIKV 3520). The collections of information in instructions for submitting comments.
defer donors at risk for ZIKV infection 21 CFR 601.12 have been approved Comments submitted electronically,
as follows: Defer for 4 weeks after the under OMB control number 0910–0338; including attachments, to http://
resolution of symptoms a donor with a and the collections of information in 21 www.regulations.gov will be posted to
history of ZIKV infection or a donor CFR 606.100(b), 606.160(b)(1), and the docket unchanged. Because your
who reports symptoms suggestive of 640.3(a) have been approved under comment will be made public, you are
ZIKV within 2 weeks of departure from OMB control number 0910–0116. solely responsible for ensuring that your
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![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
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Document Created: 2018-02-02 14:31:42
Document Modified: 2018-02-02 14:31:42
| 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 April 19, 2016. | |
| 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 | 81 FR 8505 |
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