83 FR 46174 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 177 (September 12, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 177 (September 12, 2018)
| Page Range | 46174-46176 | |
| FR Document | 2018-19743 |
[Federal Register Volume 83, Number 177 (Wednesday, September 12, 2018)] [Notices] [Pages 46174-46176] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19743] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0429] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products 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 ``Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products.'' DATES: Submit either electronic or written comments on the collection of information by November 13, 2018. 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 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 13, 2018. 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-2012-D-0429 for ``Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products.'' 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 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: Amber Sanford, Office of Operations, [[Page 46175]] Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [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. Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products OMB Control Number 0910-0731--Extension The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111- 31) offers tobacco product manufacturers several pathways to obtain an order from FDA to authorize the marketing of a new tobacco product before it may be introduced or delivered into interstate commerce. To provide assistance with these pathways to market products, FDA will meet with tobacco product manufacturers, importers, researchers, and investigators (or their representatives) when appropriate. This guidance is intended to assist persons who seek meetings with FDA relating to their research to inform the regulation of tobacco products, or to support the development or marketing of tobacco products. The original guidance issued in 2012 was revised for updating and clarity in July 2016. In the guidance, the Agency discusses, among other things: What information FDA recommends persons include in a meeting request; How and when to submit a request; and What information FDA recommends persons submit prior to a meeting. This guidance describes two collections of information: (1) The submission of a meeting request containing certain information and (2) the submission of an information package in advance of the meeting. The purpose of this proposed information collection is to allow FDA to conduct meetings with tobacco manufacturers, importers, researchers, and investigators in an effective and efficient manner. FDA issued this guidance and the revisions consistent with FDA's good guidance practices regulations (21 CFR 10.115). Meeting Requests: The guidance sets forth FDA's recommendations for materials to be included in a request for a meeting with FDA to discuss the research and development of tobacco products. In the guidance, FDA recommends that the following information be included in the meeting request: 1. Product name and FDA-assigned Submission Tracking Number (if applicable); 2. Product category (e.g., cigarettes, smokeless tobacco) (if applicable); 3. Product use (indicate for consumer use or for further manufacturing); 4. Contact information for the authorized point of contact for the company requesting the meeting; 5. The topic of the meeting being requested (e.g., a new tobacco product application, an application for permission to market a modified risk tobacco product, or investigational use of a new tobacco product); 6. A brief statement of the purpose of the meeting, which could include a discussion of the types of studies or data to be discussed at the meeting, the general nature of the primary questions to be asked, and where the meeting fits in the overall product development plans; 7. A preliminary list of the specific objectives/outcomes expected from the meeting; 8. A preliminary proposed agenda, including an estimate of the time needed and a designated speaker for each agenda item; 9. A preliminary list of specific questions, grouped by discipline (e.g., chemistry, clinical, nonclinical); 10. A list of all individuals who will attend the meeting on behalf of the tobacco product manufacturer, importer, researcher, or investigator, including titles and responsibilities; 11. The date on which the meeting information package will be received by FDA; and 12. Suggested format of the meeting (e.g., conference call, in- person meeting at FDA offices, video conference, or written response) and suggested dates and times for the meeting. Meetings are usually scheduled for 1 hour. This information will be used by the Agency to: (1) Determine the utility of the meeting, (2) identify Agency staff necessary to discuss proposed agenda items, and (3) schedule the meeting. Meeting Information Packages: An individual submitting a meeting information package to FDA in advance of a meeting should provide summary information relevant to the product and supplementary information pertaining to any issue raised by the individual or FDA to be discussed at the meeting. As stated in the guidance, FDA recommends that meeting information packages generally include updates of information that was submitted with the meeting request and, as applicable: 1. Product composition and design data summary; 2. Manufacturing and process control data summary; 3. Nonclinical data summary; 4. Clinical data summary; 5. Behavioral and product use data summary; 6. User and nonuser perception data summary; and 7. Investigational plans for studies and surveillance of the tobacco product, including a summary of proposed study protocols containing the following information (as applicable): a. Study objective(s); b. Study hypotheses; c. Study design; d. Study population (inclusion/exclusion criteria, comparison group(s)); e. Human subject protection information, including Institutional Review Board information; f. Primary and secondary endpoints (definition and success criteria); g. Sample size calculation; h. Data collection procedures; i. Duration of follow up and baseline and follow up assessments, and j. Data analysis plan(s). [[Page 46176]] The purpose of the information package is to provide Agency staff the opportunity to adequately prepare for the meeting, including the review of relevant data concerning the product. In the Agency's experience, reviewing such information is critical to achieving a productive meeting. If the information package was previously submitted in the meeting request, it should be revised, as applicable, so that the information reflects the most current and accurate information available. 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 ---------------------------------------------------------------------------------------------------------------- Meeting Requests ---------------------------------------------------------------------------------------------------------------- Combining and Sending Meeting 83 1 83 10 830 Request Letters for Manufacturers, Importers, and Researchers.................... ---------------------------------------------------------------------------------------------------------------- Meeting Information Packages ---------------------------------------------------------------------------------------------------------------- Combining and Submitting Meeting 83 1 83 18 1,494 Information Packages for Manufacturers, Importers, and Researchers.................... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 2,324 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. FDA's estimate of the number of respondents for meeting requests in table 1 is based on the number of meeting requests received and projected over the next 3 years. FDA estimates that 83 preapplication meetings will be requested. The hours per response for combining and sending meeting request letters are estimated at 10 hours each, and the total burden hours for meeting requests are expected to be 830 hours. Based on FDA's experience, the Agency expects it will take respondents this amount of time to prepare, gather, copy, and submit brief statements about the product and a description of the purpose and details of the meeting. FDA's estimates that 83 respondents will compile meeting information packages and submit to FDA at 18 hours per response. Based on FDA's experience, the Agency expects that it will take respondents 1,494 hours (83 respondents x 18 hours) to gather, copy, and submit brief statements about the product, a description of the details of the anticipated meeting, and data and information that generally would already have been generated for the planned research and/or product development. The total number of burden hours for this collection of information is estimated to be 2,324 hours (830 hours to prepare and submit meeting requests and 1,494 hours to prepare and submit information packages). Our estimated burden for the information collection reflects an overall increase of 16 respondents and 448 hours. We attribute this adjustment to an increase in the number of industry meetings as the premarket tobacco application compliance deadlines will come due in the next 3 years. Dated: September 4, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-19743 Filed 9-11-18; 8:45 am] BILLING CODE 4164-01-P
![46174 Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices
product. Section 351(k) of the PHS Act to allow 60 days for public comment in well as any attachments, except for
(42 U.S.C. 262(k)), added by the BPCI response to the notice. This notice information submitted, marked and
Act, describes the requirements for a solicits comments on ‘‘Guidance on identified, as confidential, if submitted
BLA for a proposed biosimilar product Meetings with Industry and as detailed in ‘‘Instructions.’’
or a proposed interchangeable product Investigators on the Research and Instructions: All submissions received
(351(k) BLA). Section 351(l) of the PHS Development of Tobacco Products.’’ must include the Docket No. FDA–
Act, also added by the BPCI Act, DATES: Submit either electronic or 2012–D–0429 for ‘‘Guidance on
describes certain procedures for written comments on the collection of Meetings with Industry and
exchanging patent information and information by November 13, 2018. Investigators on the Research and
resolving patent disputes between a ADDRESSES: You may submit comments
Development of Tobacco Products.’’
351(k) BLA applicant and the holder of as follows. Please note that late, Received comments, those filed in a
the BLA reference product. If a 351(k) untimely filed comments will not be timely manner (see ADDRESSES), will be
applicant is served with a complaint for considered. Electronic comments must placed in the docket and, except for
a patent infringement described in be submitted on or before November 13, those submitted as ‘‘Confidential
section 351(l)(6) of the PHS Act, the 2018. The https://www.regulations.gov Submissions,’’ publicly viewable at
applicant is required to provide the FDA electronic filing system will accept https://www.regulations.gov or at the
with notice and a copy of the complaint comments until midnight Eastern Time Dockets Management Staff between 9
within 30 days of service. FDA is at the end of November 13, 2018. a.m. and 4 p.m., Monday through
required to publish notice of a Comments received by mail/hand Friday.
complaint received under section delivery/courier (for written/paper • Confidential Submissions—To
351(l)(6)(C) of the PHS Act in the submissions) will be considered timely submit a comment with confidential
Federal Register. if they are postmarked or the delivery information that you do not wish to be
FDA received notice of the following service acceptance receipt is on or made publicly available, submit your
complaint under section 351(l)(6)(C) of before that date. comments only as a written/paper
the PHS Act: Genentech, Inc. and City submission. You should submit two
of Hope v. Amgen Inc., 1:18–cv–00924– Electronic Submissions copies total. One copy will include the
GMS (D. Del., filed July 2, 2018). Submit electronic comments in the information you claim to be confidential
FDA has only a ministerial role in following way: with a heading or cover note that states
publishing notice of a complaint • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
received under section 351(l)(6)(C) of https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
the PHS Act, and does not perform a instructions for submitting comments. Agency will review this copy, including
substantive review of the complaint. Comments submitted electronically, the claimed confidential information, in
Dated: September 6, 2018. including attachments, to https:// its consideration of comments. The
Leslie Kux, www.regulations.gov will be posted to second copy, which will have the
the docket unchanged. Because your claimed confidential information
Associate Commissioner for Policy.
comment will be made public, you are redacted/blacked out, will be available
[FR Doc. 2018–19811 Filed 9–11–18; 8:45 am]
solely responsible for ensuring that your for public viewing and posted on
BILLING CODE 4164–01–P https://www.regulations.gov. Submit
comment does not include any
confidential information that you or a both copies to the Dockets Management
third party may not wish to be posted, Staff. If you do not wish your name and
DEPARTMENT OF HEALTH AND
such as medical information, your or contact information to be made publicly
HUMAN SERVICES
anyone else’s Social Security number, or available, you can provide this
Food and Drug Administration confidential business information, such information on the cover sheet and not
as a manufacturing process. Please note in the body of your comments and you
[Docket No. FDA–2012–D–0429] must identify this information as
that if you include your name, contact
information, or other information that ‘‘confidential.’’ Any information marked
Agency Information Collection as ‘‘confidential’’ will not be disclosed
Activities; Proposed Collection; identifies you in the body of your
comments, that information will be except in accordance with 21 CFR 10.20
Comment Request; Guidance on and other applicable disclosure law. For
Meetings With Industry and posted on https://www.regulations.gov.
• If you want to submit a comment more information about FDA’s posting
Investigators on the Research and of comments to public dockets, see 80
Development of Tobacco Products with confidential information that you
do not wish to be made available to the FR 56469, September 18, 2015, or access
AGENCY: Food and Drug Administration, public, submit the comment as a the information at: https://www.gpo.gov/
HHS. written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015-
manner detailed (see ‘‘Written/Paper 23389.pdf.
ACTION: Notice.
Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
SUMMARY: The Food and Drug read background documents or the
Administration (FDA or Agency) is Written/Paper Submissions electronic and written/paper comments
announcing an opportunity for public Submit written/paper submissions as received, go to https://
comment on the proposed collection of follows: www.regulations.gov and insert the
certain information by the Agency. • Mail/Hand delivery/Courier (for docket number, found in brackets in the
daltland on DSKBBV9HB2PROD with NOTICES
Under the Paperwork Reduction Act of written/paper submissions): Dockets heading of this document, into the
1995 (PRA), Federal Agencies are Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts
required to publish notice in the Drug Administration, 5630 Fishers and/or go to the Dockets Management
Federal Register concerning each Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061,
proposed collection of information, • For written/paper comments Rockville, MD 20852.
including each proposed extension of an submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT:
existing collection of information, and Staff, FDA will post your comment, as Amber Sanford, Office of Operations,
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![46176 Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices
The purpose of the information the Agency’s experience, reviewing revised, as applicable, so that the
package is to provide Agency staff the such information is critical to achieving information reflects the most current
opportunity to adequately prepare for a productive meeting. If the information and accurate information available.
the meeting, including the review of package was previously submitted in FDA estimates the burden of this
relevant data concerning the product. In the meeting request, it should be collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Meeting Requests
Combining and Sending Meeting Request Letters for Man-
ufacturers, Importers, and Researchers .......................... 83 1 83 10 830
Meeting Information Packages
Combining and Submitting Meeting Information Packages
for Manufacturers, Importers, and Researchers .............. 83 1 83 18 1,494
Total .............................................................................. ........................ ........................ ........................ ........................ 2,324
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s estimate of the number of application compliance deadlines will Contact Person: Martha L Hare, Ph.D., RN,
respondents for meeting requests in come due in the next 3 years. Scientific Review Officer, Center for
table 1 is based on the number of Scientific Review, National Institutes of
Dated: September 4, 2018. Health, 6701 Rockledge Drive, Room 3154,
meeting requests received and projected
Leslie Kux, MSC 7770, Bethesda, MD 20892, (301) 451–
over the next 3 years. FDA estimates
Associate Commissioner for Policy. 8504, harem@mail.nih.gov.
that 83 preapplication meetings will be
requested. [FR Doc. 2018–19743 Filed 9–11–18; 8:45 am] Name of Committee: Center for Scientific
Review Special Emphasis Panel;
The hours per response for combining BILLING CODE 4164–01–P
Hypertension and Microcirculation.
and sending meeting request letters are Date: October 2, 2018.
estimated at 10 hours each, and the total Time: 8:00 a.m. to 2:00 p.m.
burden hours for meeting requests are DEPARTMENT OF HEALTH AND
HUMAN SERVICES Agenda: To review and evaluate grant
expected to be 830 hours. Based on applications.
FDA’s experience, the Agency expects it Place: Embassy Suites at the Chevy Chase
National Institutes of Health
will take respondents this amount of Pavilion, 4300 Military Road NW,
time to prepare, gather, copy, and Center for Scientific Review; Notice of Washington, DC 20015.
submit brief statements about the Closed Meetings Contact Person: Katherine M. Malinda,
product and a description of the Ph.D., Scientific Review Officer, Center for
purpose and details of the meeting. Scientific Review, National Institutes of
Pursuant to section 10(d) of the
FDA’s estimates that 83 respondents Health, 6701 Rockledge Drive, Room 4140,
Federal Advisory Committee Act, as
will compile meeting information MSC 7814, Bethesda, MD 20892, 301–435–
amended, notice is hereby given of the 0912, Katherine_Malinda@csr.nih.gov.
packages and submit to FDA at 18 hours following meetings.
per response. Based on FDA’s Name of Committee: Center for Scientific
The meetings will be closed to the Review Special Emphasis Panel; Member
experience, the Agency expects that it
public in accordance with the Conflict: Dental, Microbiology and Oral
will take respondents 1,494 hours (83
provisions set forth in sections Biology.
respondents × 18 hours) to gather, copy, Date: October 3, 2018.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
and submit brief statements about the Time: 12:00 p.m. to 3:00 p.m.
as amended. The grant applications and
product, a description of the details of Agenda: To review and evaluate grant
the discussions could disclose
the anticipated meeting, and data and applications.
confidential trade secrets or commercial
information that generally would Place: National Institutes of Health, 6701
property such as patentable material,
already have been generated for the Rockledge Drive, Bethesda, MD 20892
and personal information concerning
planned research and/or product (Telephone Conference Call).
individuals associated with the grant Contact Person: Baljit S Moonga, Ph.D.,
development.
applications, the disclosure of which Scientific Review Officer, Center for
The total number of burden hours for would constitute a clearly unwarranted
this collection of information is Scientific Review, National Institutes of
invasion of personal privacy. Health, 6701 Rockledge Drive, Room 4214,
estimated to be 2,324 hours (830 hours
Name of Committee: Healthcare Delivery MSC 7806, Bethesda, MD 20892, 301–435–
to prepare and submit meeting requests
and Methodologies Integrated Review Group; 1777, moongabs@mail.nih.gov.
and 1,494 hours to prepare and submit
daltland on DSKBBV9HB2PROD with NOTICES
information packages). Clinical Management of Patients in Name of Committee: Center for Scientific
Community-based Settings Study Section. Review Special Emphasis Panel; PAR–17–
Our estimated burden for the Date: September 27–28, 2018. 094: Maximizing Investigators’ Research
information collection reflects an Time: 8:00 a.m. to 5:00 p.m. Award (R35).
overall increase of 16 respondents and Agenda: To review and evaluate grant Date: October 10–11, 2018.
448 hours. We attribute this adjustment applications. Time: 8:00 a.m. to 6:00 p.m.
to an increase in the number of industry Place: Warwick Denver, 1776 Grant Street, Agenda: To review and evaluate grant
meetings as the premarket tobacco Denver, CO 80203. applications.
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Document Created: 2018-09-12 02:06:52
Document Modified: 2018-09-12 02:06:52
| 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 13, 2018. | |
| Contact | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 83 FR 46174 |
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