83 FR 45251 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 173 (September 6, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 173 (September 6, 2018)
| Page Range | 45251-45253 | |
| FR Document | 2018-19353 |
[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)] [Notices] [Pages 45251-45253] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19353] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0147] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for 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 for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products.'' DATES: Submit either electronic or written comments on the collection of information by November 5, 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 5, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 5, 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-2011-D-0147 for ``Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for 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 [[Page 45252]] 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, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, 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. Guidance for Industry and Food and Drug Administration Staff on Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products OMB Control Number 0910-0673--Extension On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111- 31) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding, among other things, a chapter granting FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. The FD&C Act, as amended by the Tobacco Control Act, requires that before a new tobacco product may be introduced or delivered for introduction into interstate commerce, the new tobacco product must undergo premarket review by FDA. FDA must issue an order authorizing the commercial distribution of the new tobacco product or find the product exempt from the requirements of substantial equivalence under section 910(a)(2)(A) of the FD&C Act, before the product may be introduced into commercial distribution (section 910 of the FD&C Act (21 U.S.C. 387j)). FDA has issued a guidance document containing recommendations for preparing substantial equivalence reports (SE Reports) under section 905(j)(1)(A)(i). A tobacco product manufacturer must show that a new tobacco product is substantially equivalent, within the meaning of section 910, to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or to a tobacco product that the Secretary has previously determined, pursuant to subsection (a)(3) of section 910, is substantially equivalent and that it is in compliance with the requirements of the FD&C Act. The comparison product chosen by the tobacco product manufacturer is referred to by FDA as the predicate tobacco product. The guidance document associated with this collection of information contains recommendations on preparing reports intended to demonstrate substantial equivalence to a predicate tobacco product and compliance with the FD&C Act as required under section 905(j)(1)(A)(i). Submission of a section 905(j)(1)(A)(i) report intended to demonstrate substantial equivalence and, in response, an order from the Agency finding that the new tobacco product is substantially equivalent to a predicate tobacco product and in compliance with the requirements of the FD& C Act, is one means for a new tobacco product to legally enter the market. FDA's guidance entitled ``Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions'' (December 2016). This guidance may be accessed at https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm). In that guidance, FDA recommends that certain modifications might be addressed in a ``Product Quantity Change Report,'' which is a more streamlined SE Reports for certain modifications that should be easier for manufacturers to prepare. The Tobacco Control Act also gave FDA the authority to issue a regulation deeming all other products that meet the statutory definition of a tobacco product to be subject to Chapter IX of the FD&C Act (section 901(b) (21 U.S.C. 387a(b)) of the FD&C Act). On May 10, 2016, FDA issued that rule, extending FDA's tobacco product authority to all products that meet the definition of tobacco product in the law (except for accessories of newly regulated tobacco products), including electronic nicotine delivery systems, cigars, hookah, pipe tobacco, nicotine gels, dissolvables that were not already subject to the FD&C Act, and other tobacco products that may be developed in the future (81 FR 28974 at 28976) (``the Deeming final rule''). FDA estimates the burden of this collection of information as follows: [[Page 45253]] 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 ---------------------------------------------------------------------------------------------------------------- Full SE 905(j)(1)(A)(i) and 683 1 683 300 204,900 910(a)......................... Full SE 905(j)(1)(A)(i) and 456 1 456 90 41,040 910(a) Bundled................. Product Quantity Change SE 239 1 239 87 20,793 Report......................... Product Quantity Change Bundled 192 1 192 62 11,904 SE Report...................... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 278,637 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. FDA's estimates are based on experience with SE Reports, initial updated deemed registration and listing data, interactions with the industry, and information related to other regulated products. The estimated number of SE Reports is expected to increase from an annual average of 979 to 1,570. When groups of full or product quantity change SE Reports have identical content, they may be bundled; when a group of similar reports are bundled, the subsequent bundled reports are expected to take less time to prepare than the initial report. FDA has based these estimates on information it now has available from interactions with the industry, information related to other regulated products, and FDA expectations regarding the tobacco industry's use of the section 905(j) pathway to market their products. Table 1 describes the annual reporting burden as a result of the implementation of the substantial equivalence requirements of sections 905(j)(1)(A)(i) and 910(a) of the FD&C Act (21 U.S.C. 387j(a)) for an SE application. FDA estimates that 683 respondents will prepare and submit 683 section 905(j)(1)(A)(i) SE Reports each year. In addition, anyone submitting an SE Report is required to submit an environmental assessment (EA) under 21 CFR 25.40. The burden for environmental reports has been included in the burden per response for each type of SE report. Based on FDA's experience with EAs for currently regulated tobacco products, we expect industry to spend 80 hours to prepare an environmental assessment for a SE Report. Thus, FDA estimates that it will take a manufacturer approximately 300 hours per report to prepare an SE Report and the EA for a new tobacco product, which is a total of 204,900 hours. In addition, we estimate receiving 456 Full SE Bundled Reports at 90 hours per submission for a total of 41,040 hours. FDA estimates that it will receive 239 Product Quantity Change SE Reports and that it will take a manufacturer approximately 87 hours to prepare this report for a total of 20,793 hours. This includes time to prepare the environmental assessment, which FDA believes will take less time due to the typically more limited modification(s) included in a Product Quantity Change SE Report. We estimate receiving 192 Product Quantity Change Bundled SE Reports at approximately 62 hours per submission for a total of 11,904 hours, this number excludes the time for the initial SE Report which was previously account for. Therefore, FDA estimates the burden for submission of SE information will be 278,637 hours. This is an increase of 106,759 hours from the currently approved burden. We attribute this increase to an increase in the number of SE Reports we expect related to Deemed products (e.g., based on the initial registration and listing information). Dated: August 31, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-19353 Filed 9-5-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 45251
SIX DRAFT GUIDANCES PUBLISHED JULY 12, 2018—Continued
Docket No. Draft guidance document title FR cite
FDA–2018–D–2258 ........ Human Gene Therapy for Rare Diseases; Draft Guidance for Industry ................................................. 83 FR 32303
The Agency has received requests for SUMMARY: The Food and Drug comments, that information will be
a 60-day extension of the comment Administration (FDA or Agency) is posted on https://www.regulations.gov.
period for the six draft guidance announcing an opportunity for public • If you want to submit a comment
documents. These requests conveyed comment on the proposed collection of with confidential information that you
concern that the current 90-day certain information by the Agency. do not wish to be made available to the
comment period does not allow Under the Paperwork Reduction Act of public, submit the comment as a
sufficient time to develop a meaningful 1995 (PRA), Federal Agencies are written/paper submission and in the
or thoughtful response to the draft required to publish notice in the manner detailed (see ‘‘Written/Paper
guidance documents. FEDERAL REGISTER concerning each Submissions’’ and ‘‘Instructions’’).
FDA has considered these requests proposed collection of information, Written/Paper Submissions
and is extending the comment period including each proposed extension of an
for the six draft guidance documents for existing collection of information, and Submit written/paper submissions as
60 days, until December 10, 2018. The to allow 60 days for public comment in follows:
Agency believes that a 60-day extension response to the notice. This notice • Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
allows adequate time for interested solicits comments on ‘‘Guidance for
Management Staff (HFA–305), Food and
persons to submit comments. Industry and Food and Drug
Drug Administration, 5630 Fishers
Administration Staff; Section 905(j)
II. References Lane, Rm. 1061, Rockville, MD 20852.
Reports: Demonstrating Substantial • For written/paper comments
The following references are on Equivalence for Tobacco Products.’’ submitted to the Dockets Management
display in the Dockets Management
DATES: Submit either electronic or Staff, FDA will post your comment, as
Staff (see ADDRESSES) and are available
written comments on the collection of well as any attachments, except for
for viewing by interested persons
information by November 5, 2018. information submitted, marked and
between 9 a.m. and 4 p.m., Monday
identified, as confidential, if submitted
through Friday; they are also available ADDRESSES: You may submit comments
as detailed in ‘‘Instructions.’’
electronically at https:// as follows. Please note that late,
Instructions: All submissions received
www.regulations.gov. untimely filed comments will not be must include the Docket No. FDA–
1. Letter from Robert Falb, Director, U.S. considered. Electronic comments must 2011–D–0147 for ‘‘Guidance for
Policy and Advocacy, Alliance for be submitted on or before November 5, Industry and Food and Drug
Regenerative Medicine, to Dr. Peter 2018. The https://www.regulations.gov Administration Staff; Section 905(j)
Marks, Director, Center for Biologics electronic filing system will accept Reports: Demonstrating Substantial
Evaluation and Research, FDA (July 23, comments until midnight Eastern Time Equivalence for Tobacco Products.’’
2018). at the end of November 5, 2018.
2. Letter from Sesquile Ramon, Ph.D., Received comments, those filed in a
Comments received by mail/hand timely manner (see ADDRESSES), will be
Director, Science and Regulatory Affairs, delivery/courier (for written/paper
Biotechnology Innovation Organization, placed in the docket and, except for
submissions) will be considered timely those submitted as ‘‘Confidential
to FDA Dockets Management Staff
(August 3, 2018). if they are postmarked or the delivery Submissions,’’ publicly viewable at
service acceptance receipt is on or https://www.regulations.gov or at the
Dated: August 29, 2018. before that date.
Leslie Kux, Dockets Management Staff between 9
Associate Commissioner for Policy. Electronic Submissions a.m. and 4 p.m., Monday through
Friday.
[FR Doc. 2018–19303 Filed 9–5–18; 8:45 am] Submit electronic comments in the • Confidential Submissions—To
BILLING CODE 4164–01–P following way: submit a comment with confidential
• Federal eRulemaking Portal: information that you do not wish to be
https://www.regulations.gov. Follow the made publicly available, submit your
DEPARTMENT OF HEALTH AND instructions for submitting comments. comments only as a written/paper
HUMAN SERVICES Comments submitted electronically, submission. You should submit two
Food and Drug Administration including attachments, to https:// copies total. One copy will include the
www.regulations.gov will be posted to information you claim to be confidential
[Docket No. FDA–2011–D–0147] the docket unchanged. Because your with a heading or cover note that states
comment will be made public, you are ‘‘THIS DOCUMENT CONTAINS
Agency Information Collection solely responsible for ensuring that your CONFIDENTIAL INFORMATION.’’ The
Activities; Proposed Collection; comment does not include any Agency will review this copy, including
Comment Request; Guidance for confidential information that you or a the claimed confidential information, in
Industry and Food and Drug third party may not wish to be posted, its consideration of comments. The
daltland on DSKBBV9HB2PROD with NOTICES
Administration Staff; Section 905(j) such as medical information, your or second copy, which will have the
Reports: Demonstrating Substantial anyone else’s Social Security number, or claimed confidential information
Equivalence for Tobacco Products confidential business information, such redacted/blacked out, will be available
AGENCY: Food and Drug Administration, as a manufacturing process. Please note for public viewing and posted on
HHS. that if you include your name, contact https://www.regulations.gov. Submit
information, or other information that both copies to the Dockets Management
ACTION: Notice.
identifies you in the body of your Staff. If you do not wish your name and
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![Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 45253
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
Full SE 905(j)(1)(A)(i) and 910(a) ........................................ 683 1 683 300 204,900
Full SE 905(j)(1)(A)(i) and 910(a) Bundled ......................... 456 1 456 90 41,040
Product Quantity Change SE Report .................................. 239 1 239 87 20,793
Product Quantity Change Bundled SE Report .................... 192 1 192 62 11,904
Total .............................................................................. ........................ ........................ ........................ ........................ 278,637
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s estimates are based on report for a total of 20,793 hours. This representatives to serve on certain
experience with SE Reports, initial includes time to prepare the device panels of the MDAC in the
updated deemed registration and listing environmental assessment, which FDA CDRH. A nominee may either be self-
data, interactions with the industry, and believes will take less time due to the nominated or nominated by an
information related to other regulated typically more limited modification(s) organization to serve as a nonvoting
products. The estimated number of SE included in a Product Quantity Change industry representative. Nominations
Reports is expected to increase from an SE Report. We estimate receiving 192 will be accepted for current and
annual average of 979 to 1,570. Product Quantity Change Bundled SE upcoming vacancies effective with this
When groups of full or product Reports at approximately 62 hours per notice.
quantity change SE Reports have submission for a total of 11,904 hours,
identical content, they may be bundled; this number excludes the time for the DATES: Any industry organization
when a group of similar reports are initial SE Report which was previously interested in participating in the
bundled, the subsequent bundled account for. selection of an appropriate nonvoting
reports are expected to take less time to Therefore, FDA estimates the burden member to represent industry interests
prepare than the initial report. for submission of SE information will be must send a letter stating that interest to
FDA has based these estimates on 278,637 hours. This is an increase of FDA by October 9, 2018 (see sections I
information it now has available from 106,759 hours from the currently and II of this document for further
interactions with the industry, approved burden. We attribute this details). Concurrently, nomination
information related to other regulated increase to an increase in the number of materials for prospective candidates
products, and FDA expectations SE Reports we expect related to Deemed should be sent to FDA by October 9,
regarding the tobacco industry’s use of products (e.g., based on the initial 2018.
the section 905(j) pathway to market registration and listing information).
their products. Table 1 describes the ADDRESSES: All statements of interest
annual reporting burden as a result of Dated: August 31, 2018. from industry organizations interested
the implementation of the substantial Leslie Kux, in participating in the selection process
equivalence requirements of sections Associate Commissioner for Policy. of nonvoting industry representative
905(j)(1)(A)(i) and 910(a) of the FD&C [FR Doc. 2018–19353 Filed 9–5–18; 8:45 am] nomination should be sent to Margaret
Act (21 U.S.C. 387j(a)) for an SE BILLING CODE 4164–01–P Ames (see FOR FURTHER INFORMATION
application. CONTACT). All nominations for
FDA estimates that 683 respondents nonvoting industry representatives
will prepare and submit 683 section DEPARTMENT OF HEALTH AND should be submitted electronically by
905(j)(1)(A)(i) SE Reports each year. In HUMAN SERVICES accessing the FDA Advisory Committee
addition, anyone submitting an SE Membership Nomination Portal: https://
Report is required to submit an Food and Drug Administration www.accessdata.fda.gov/scripts/
environmental assessment (EA) under [Docket No. FDA–2018–N–3179] FACTRSPortal/FACTRS/index.cfm or by
21 CFR 25.40. The burden for mail to Advisory Committee Oversight
environmental reports has been Request for Nominations on Public and Management Staff, Food and Drug
included in the burden per response for Advisory Panels of the Medical Administration, 10903 New Hampshire
each type of SE report. Based on FDA’s Devices Advisory Committee Ave., Bldg. 32, Rm. 5103, Silver Spring,
experience with EAs for currently MD 20993–0002. Information about
regulated tobacco products, we expect AGENCY: Food and Drug Administration, becoming a member of an FDA advisory
industry to spend 80 hours to prepare HHS. committee can also be obtained by
an environmental assessment for a SE ACTION: Notice. visiting FDA’s website at https://
Report. Thus, FDA estimates that it will www.fda.gov/AdvisoryCommittees/
take a manufacturer approximately 300 SUMMARY: The Food and Drug default.htm.
hours per report to prepare an SE Report Administration (FDA) is requesting that
and the EA for a new tobacco product, any industry organizations interested in FOR FURTHER INFORMATION CONTACT:
which is a total of 204,900 hours. participating in the selection of Margaret Ames, Division of Workforce
daltland on DSKBBV9HB2PROD with NOTICES
In addition, we estimate receiving 456 nonvoting industry representatives to Management, Center for Devices and
Full SE Bundled Reports at 90 hours per serve on certain panels of the Medical Radiological Health, Food and Drug
submission for a total of 41,040 hours. Devices Advisory Committee (MDAC or Administration, 10903 New Hampshire
FDA estimates that it will receive 239 Committee) in the Center for Devices Ave., Bldg. 66, Rm. 5264, Silver Spring,
Product Quantity Change SE Reports and Radiological Health (CDRH) notify MD 20993, 301–796–5960, Fax: 301–
and that it will take a manufacturer FDA in writing. FDA is also requesting 847–8505, email: margaret.ames@
approximately 87 hours to prepare this nominations for nonvoting industry fda.hhs.gov.
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Document Created: 2018-09-05 23:56:32
Document Modified: 2018-09-05 23:56:32
| 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 5, 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 45251 |
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