82 FR 43761 - Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining Lists of United States Manufacturers/Processors With Interest in Exporting Center for Food Safety and Applied Nutrition-Regulated Products to China
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 180 (September 19, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 180 (September 19, 2017)
| Page Range | 43761-43764 | |
| FR Document | 2017-19890 |
[Federal Register Volume 82, Number 180 (Tuesday, September 19, 2017)] [Notices] [Pages 43761-43764] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-19890] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-0192] Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining Lists of United States Manufacturers/Processors With Interest in Exporting Center for Food Safety and Applied Nutrition-Regulated Products to China AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) 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 information collection provisions found in the [[Page 43762]] guidance entitled ``Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula, and Formula for Young Children Manufacturers/Processors with Interest in Exporting to China: Guidance for Industry.'' DATES: Submit either electronic or written comments on the collection of information by November 20, 2017. 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 November 20, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 20, 2017. 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-2014-N-0192 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining Lists of U.S. Manufacturers/Processors with Interest in Exporting CFSAN-Regulated Products to China.'' 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 Office 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, 10A12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov. 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. Establishing and Maintaining Lists of U.S. Manufacturers/Processors With Interest in Exporting CFSAN-Regulated Products to China--21 U.S.C. 371 OMB Control Number 0910-0839--Extension The United States exports a large volume and variety of foods in international trade. For certain food products, foreign governments may require assurances from the responsible authority of the country of origin of an imported food product that the manufacturer/processor of the food [[Page 43763]] product is in compliance with applicable country of origin regulatory requirements. Some foreign governments establish additional requirements with which exporters are required to comply. In August 2011, China's State General Administration of the People's Republic of China for Quality Supervision, Inspection, and Quarantine (AQSIQ) published the ``Administrative Measures for Registration of Overseas Manufacturers,'' known as AQSIQ Decree 145 (https://gain.fas.usda.gov/Recent%20GAIN%20Publications/Registration%20of%20Overseas%20Food%20Manufacturing%20Facilities%20_Beijing_China%20-%20Peoples%20Republic%20of_6-27-2012.pdf), which became effective May 1, 2012. AQSIQ Decree 145, among other requirements, mandates that foreign competent authorities provide the Certification and Accreditation Administration of China (CNCA) with a name list of overseas manufacturers of imported food applying for registration with CNCA for each commodity that CNCA has deemed to require registration. As of June 2017, milk and milk products, seafood, infant formula, and formula for young children are among the commodities for which CNCA requires registration of overseas manufacturers under AQSIQ Decree 145. CNCA has recognized FDA/Center for Food Safety and Applied Nutrition (CFSAN) as the competent food safety authority in the United States to establish and maintain lists of U.S. establishments that intend to export U.S. milk and milk products, seafood, infant formula, and/or formula for young children to China, including the corresponding products manufactured by each establishment and intended for export to China. In order to implement AQSIQ Decree 145, FDA and CNCA entered into a Memorandum of Understanding (China MOU) on June 15, 2017, which sets out the two agencies' intent to facilitate the conditions under which U.S. manufacturers/processors can export to China milk and milk products, seafood, infant formula, and/or formula for young children. Under the China MOU, FDA intends to establish and maintain lists that identify U.S. manufacturers/processors that have expressed interest to FDA in exporting milk and milk products, seafood, infant formula, and/or formula for young children to China; are subject to our jurisdiction; and have been found by FDA to be in good regulatory standing with FDA, including a finding by FDA that, during the most recent facility inspection, the manufacturers/processors have been found to be in substantial compliance with all applicable FDA regulations, including, but not limited to, current good manufacturing practice requirements for the identified products for export to China. Further, the China MOU provides for FDA to receive evidence that the manufacturer/processor has been certified by a third-party certification body--as acknowledged by CNCA--to meet the relevant standards, laws, and regulations of China for the identified food products for export to China. On June 28, 2017, FDA issued a guidance document entitled, ``Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula, and Formula for Young Children Manufacturers/Processors with Interest in Exporting to China: Guidance for Industry'' which can be found at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm378777.htm. The guidance informs industry of information that FDA and CNCA will collect to manage the listing of these manufacturers/ processors and foods for export to China pursuant to AQSIQ Decree 145 and the China MOU. In accordance with 5 CFR 1320.13, FDA requested emergency review and approval of the collections of information found in the guidance document. The routine course of approval would have delayed our ability to collect the information from firms and, thus, would have been disruptive in our efforts to facilitate exports of food in compliance with requirements established by China in AQSIQ Decree 145. OMB granted the approval under emergency clearance procedures on June 27, 2017. FDA uses the information submitted by manufacturers/processors to consider them for inclusion on FDA's lists of eligible manufacturers/ processors that may ship food products to China, which we maintain. Updates to the FDA lists are sent to CNCA, which publishes quarterly its version of the information in the FDA lists on China's Web site (http://english.cnca.gov.cn/). The purpose of the lists is to assist China in its determination of which U.S. milk and milk product, seafood, infant formula, or formula for young children manufacturers/ processors are eligible to import these products into China under applicable Chinese law. Currently FDA maintains lists for milk and milk product, seafood, infant formula, and formula for young children but FDA wants to be prepared if CNCA requires listing of manufacturers/ processors of other CFSAN-regulated products in the future. As such, the information collection request is not limited to milk and milk product, seafood, infant formula, and formula for young children but also may include other CFSAN-regulated products. FDA estimates the burden of this collection of information as follows: 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 ---------------------------------------------------------------------------------------------------------------- New written requests to be 370 1 370 1 370 placed on the lists............ Third-party certification....... 370 1 370 21 7,770 Biennial update................. 555 1 555 1 555 Third-party certification 555 1 555 21 11,655 biennial update................ Occasional updates.............. 100 1 100 0.5 50 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 20,400 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The burden for this information collection has not changed since the last OMB approval. Based on our experience maintaining other export lists, we estimate that, annually, an average of 370 new manufacturers/ processors will submit written requests to be placed on the China lists. The estimate of the number of hours that it will take a [[Page 43764]] manufacturer/processor to gather the information needed to be placed on a list or update its information is based on FDA's experience with manufacturers/processors submitting similar requests. FDA believes that the information to be submitted will be readily available to manufacturers/processors. We estimate that a firm will require 1 hour to read the guidance, gather the information needed, and prepare a communication to FDA that contains the information needed to request that the manufacturer/processor be placed on a list. To be placed on a list, manufacturers/processors should provide FDA with evidence that they have obtained third-party certification from a CNCA-acknowledged certifier that the manufacturer/processor complies with the standards, laws, and regulations of China according to relevant requirements specified in AQSIQ Decree 145. Based on our experience with other certification programs, FDA estimates that it will take each new manufacturer/processor about 21 hours to complete the third-party certification process for a total of 7,770 burden hours (370 manufacturers/processors x 21 hours). Under the guidance, every 2 years each manufacturer/processor on the lists must provide updated information in order to remain on the lists. FDA estimates that each year approximately half of the manufacturers/processors on the lists, or 555 manufacturers/processors (1,110 manufacturers/processors x 0.5 = 555), will resubmit the information to remain on the lists. We estimate that a manufacturer/ processor already on the lists will require 1 hour to biennially update and resubmit the information to FDA, including time reviewing the information and corresponding with FDA, for a total of 555 hours. During the biennial update, manufacturers/processors also need to be recertified by a third-party certifier to remain on the lists. FDA estimates that each year approximately half of the manufacturers/ processors on the lists, 555 manufacturers/processors (1,110 manufacturers/processors x 0.5 = 555), will get recertified. We estimate that it will take each manufacturer/processor about 21 hours to complete the certification process for a total of 11,655 burden hours (555 manufacturers/processors x 21 hours). FDA expects that, each year, approximately 100 manufacturers/ processors will need to submit an occasional update and each manufacturer/processor will require 0.5 hours to prepare a communication to FDA reporting the change, for a total of 50 hours. Dated: September 13, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-19890 Filed 9-18-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices 43761
and toolkits for LHDs and community research. This study will generate science activities and resources.
groups so that they can align their information that can help define the Researchers will identify potential
efforts and strengthen the benefits and phenomenon of disaster citizen science interview participants through literature
positive impacts of citizen science and may result in nationally reviews and snowball sampling in a
activities. For interviews, the representative baseline data that can phased approach starting with citizen
information collection will target citizen support changes in citizen science science and LHD organizations.
scientists and end users of citizen awareness, barriers, and activities. Researchers will sample for maximum
science data. While interviews will be hypothesis variation in order to capture the full
Citizen science is defined as research generating and provide rich data on the range of citizen scientist and health
activities (e.g., data collection, analysis, experiences with citizen science to date department experiences on this topic.
and reporting) performed by members of across all stakeholders active in this For the survey, the researchers will
the general public without any enterprise, the nationally-representative target a nationally representative sample
particular training in science. Citizen survey data will allow us to generalize of 600 local health officials and will
science is growing in popularity, fueled findings to the full population of LHDs apply survey weights to ensure that
in part by growing use of smartphones in the U.S. findings have external validity and can
and other personal devices in the CDC will collaborate with a contractor
be generalized to LHDs in the U.S. The
population. Although citizen collection to implement this project. Researchers
survey, which will take 30 minutes to
and use of data during disasters has will target citizen scientists and their
complete, will include questions on
increased exponentially in recent years partners (e.g., academics who work with
both citizen science as applied to
and there is great policy interest in the citizen scientists on research projects)
disaster preparedness and response, and
phenomenon, there has been no robust and LHDs in a position to use citizen
citizen science as occurring in other
research to date on the use of, barriers science data to inform public health
contexts (such as environmental
to, and impact of citizen science in decision-making. For interviews,
health)to draw lessons for preparedness
disasters. Local health departments researchers will sample for maximum
and response.
(LHDs) lack tools to respond to and variation, seeking to obtain variation on
coordinate with citizen science U.S. region, type and sophistication of OPHPR anticipates that the
activities within communities. citizen science project, type of disaster knowledge resulting from this research
Furthermore, citizen science encountered, and previous experience project will contribute significantly to
organizations lack information on how with disaster citizen science. the evidence base for preparedness and
to organize their activities for ultimate The researchers aim to conduct 35–55 response and lead to improved
impact. individual and group facilitated semi- efficiency, effectiveness, and outcomes
This is an exploratory study and is the structured interviews, each lasting in several domains.
first of its kind to explore the growing approximately 60 minutes, to cover Participation in this study is
phenomenon of disaster citizen science. topics including benefits and uses of voluntary. There are no costs to
Disaster citizen science is a rapidly citizen science, barriers to and respondents other than their time. A
growing field that is the focus of policy facilitators of citizen science, and summary of annualized burden hours is
interest, but currently devoid of strengths and limitations of citizen below.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average
Number of responses burden per Total burden
Type of respondents Form name respondents per response (in hours)
respondent (in hours)
Citizen scientists and their partners; Interview Guide (semi-structured 55 1 75/60 69
local health officials. questionnaire).
Local health departments ................. Survey .............................................. 300 1 30/60 150
Total ........................................... ........................................................... ........................ ........................ ........................ 219
Leroy A. Richardson, DEPARTMENT OF HEALTH AND ACTION: Notice.
Chief, Information Collection Review Office, HUMAN SERVICES
Office of Scientific Integrity, Office of the SUMMARY: The Food and Drug
Associate Director for Science, Office of the Food and Drug Administration Administration (FDA or Agency) is
Director, Centers for Disease Control and announcing an opportunity for public
Prevention. [Docket No. FDA–2014–N–0192] comment on the proposed collection of
[FR Doc. 2017–19824 Filed 9–18–17; 8:45 am] certain information by the Agency.
BILLING CODE 4163–18–P Agency Information Collection Under the Paperwork Reduction Act of
Activities; Proposed Collection; 1995 (PRA), Federal Agencies are
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Comment Request; Establishing and required to publish notice in the
Maintaining Lists of United States Federal Register concerning each
Manufacturers/Processors With proposed collection of information,
Interest in Exporting Center for Food including each proposed extension of an
Safety and Applied Nutrition-Regulated existing collection of information, and
Products to China to allow 60 days for public comment in
response to the notice. This notice
AGENCY: Food and Drug Administration, solicits comments on the information
HHS. collection provisions found in the
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![43764 Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices
manufacturer/processor to gather the FDA reporting the change, for a total of Experimental Study on Warning
information needed to be placed on a 50 hours. Statements for Cigarette Graphic Health
list or update its information is based on Dated: September 13, 2017. Warnings
FDA’s experience with manufacturers/
Anna K. Abram, OMB Control Number 0910–NEW
processors submitting similar requests.
FDA believes that the information to be Deputy Commissioner for Policy, Planning, The health risks associated with the
Legislation, and Analysis. use of cigarettes can be significant and
submitted will be readily available to
manufacturers/processors. We estimate [FR Doc. 2017–19890 Filed 9–18–17; 8:45 am] far-reaching. In 2009, Congress enacted
that a firm will require 1 hour to read BILLING CODE 4164–01–P the Tobacco Control Act (TCA) (Pub. L.
the guidance, gather the information 111–31), which amends the Federal
needed, and prepare a communication Food, Drug, and Cosmetic Act to grant
to FDA that contains the information DEPARTMENT OF HEALTH AND FDA authority to regulate the
needed to request that the HUMAN SERVICES manufacture, marketing, and
manufacturer/processor be placed on a distribution of tobacco products to
Food and Drug Administration protect the public health and to reduce
list.
To be placed on a list, manufacturers/ tobacco use by minors. Section 201 of
processors should provide FDA with [Docket No. FDA–2017–N–0932] the Tobacco Control Act amends section
evidence that they have obtained third- 4 of the Federal Cigarette Labeling and
Agency Information Collection Advertising Act (FCLAA) (15 U.S.C.
party certification from a CNCA-
Activities; Submission for Office of 1333) to require FDA to issue
acknowledged certifier that the
Management and Budget Review; ‘‘regulations that require color graphics
manufacturer/processor complies with
Comment Request; Experimental depicting the negative health
the standards, laws, and regulations of
China according to relevant
Study on Warning Statements for consequences of smoking to accompany
requirements specified in AQSIQ Decree
Cigarette Graphic Health Warnings the label statements specified in
subsection (a)(1).’’ Section 202(b) of the
145. Based on our experience with other
AGENCY: Food and Drug Administration, Tobacco Control Act further amends
certification programs, FDA estimates
HHS. section 4 of the FCLAA by adding that
that it will take each new manufacturer/
the Secretary, through notice and
processor about 21 hours to complete ACTION: Notice.
comment rulemaking, may adjust the
the third-party certification process for
‘‘text of any of the label requirements
a total of 7,770 burden hours (370 SUMMARY: The Food and Drug . . . . if the Secretary finds that such a
manufacturers/processors × 21 hours). Administration (FDA) is announcing change would promote greater public
Under the guidance, every 2 years that a proposed collection of understanding of the risks associated
each manufacturer/processor on the lists information has been submitted to the with the use of tobacco products.’’
must provide updated information in Office of Management and Budget In the Federal Register of June 22,
order to remain on the lists. FDA (OMB) for review and clearance under 2011 (76 FR 36628), FDA issued a final
estimates that each year approximately the Paperwork Reduction Act of 1995. rule entitled ‘‘Required Warnings for
half of the manufacturers/processors on Cigarette Packages and
DATES: Fax written comments on the
the lists, or 555 manufacturers/ Advertisements,’’ which specified nine
collection of information by October 19,
processors (1,110 manufacturers/ images to accompany new textual
2017.
processors × 0.5 = 555), will resubmit warning statements for cigarettes.
the information to remain on the lists. ADDRESSES: To ensure that comments on Although the rule was scheduled to
We estimate that a manufacturer/ the information collection are received, become effective 15 months after it
processor already on the lists will OMB recommends that written issued, a panel of the U.S. Court of
require 1 hour to biennially update and comments be faxed to the Office of Appeals of the District of Columbia
resubmit the information to FDA, Information and Regulatory Affairs, held, on August 24, 2012, that the rule
including time reviewing the OMB, Attn: FDA Desk Officer, Fax: 202– in its current form violated the First
information and corresponding with 395–7285, or emailed to oira_ Amendment. In a letter to Congress on
FDA, for a total of 555 hours. submission@omb.eop.gov. All March 15, 2013, the Attorney General
During the biennial update, comments should be identified with the reported FDA’s intention to undertake
manufacturers/processors also need to OMB control number 0910–NEW and research to support a new rulemaking
be recertified by a third-party certifier to title ‘‘Experimental Study on Warning consistent with the Tobacco Control
remain on the lists. FDA estimates that Statements for Cigarette Graphic Health Act. Preliminary research has been
each year approximately half of the Warnings.’’ Also include the FDA underway since 2013. Informed by the
manufacturers/processors on the lists, docket number found in brackets in the previous court decisions on this matter,
555 manufacturers/processors (1,110 heading of this document. including on the First Amendment, the
manufacturers/processors × 0.5 = 555), next phase of the research includes the
FOR FURTHER INFORMATION CONTACT:
will get recertified. We estimate that it study proposed here, which is an effort
Jonalynn Capezzuto, Office of
will take each manufacturer/processor by FDA to collect data concerning
Operations, Food and Drug
about 21 hours to complete the revised textual warning statements for
Administration, Three White Flint
certification process for a total of 11,655
asabaliauskas on DSKBBXCHB2PROD with NOTICES
North, 10A63, 11601 Landsdown St., use with new images as part of cigarette
burden hours (555 manufacturers/ graphic health warnings, and their
North Bethesda, MD 20852, 301–796–
processors × 21 hours). potential impact on public
3794, PRAStaff@fda.hhs.gov.
FDA expects that, each year, understanding of the risks associated
approximately 100 manufacturers/ SUPPLEMENTARY INFORMATION: In with the use of cigarettes.
processors will need to submit an compliance with 44 U.S.C. 3507, FDA As currently proposed, this
occasional update and each has submitted the following proposed Experimental Study on Warning
manufacturer/processor will require 0.5 collection of information to OMB for Statements for Cigarette Graphic Health
hours to prepare a communication to review and clearance. Warnings is a voluntary online
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Document Created: 2018-10-24 14:19:37
Document Modified: 2018-10-24 14:19:37
| 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 November 20, 2017. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 82 FR 43761 |
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