82 FR 24131 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 100 (May 25, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 100 (May 25, 2017)
| Page Range | 24131-24133 | |
| FR Document | 2017-10712 |
[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)] [Notices] [Pages 24131-24133] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-10712] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0118] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by June 26, 2017. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0520. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002--21 CFR 1.278 to 1.285, OMB Control Number 0910-0520 The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) added section 801(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 381(m)), which requires that FDA receives prior notice for food, including food for animals, that is imported or offered for import into the United States. Sections 1.278 to 1.282 of FDA regulations (21 CFR 1.278 to 1.282) set forth the requirements for submitting prior notice; Sec. Sec. 1.283(d) and 1.285(j) (21 CFR 1.283(d) and 1.285(j)) set forth the procedure for requesting the Agency review after FDA has refused admission of an article of food under section 801(m)(1) of the FD&C Act or placed an article of food under hold under section 801(l); and Sec. 1.285(i) sets forth the procedure for post-hold submissions. Section 304 of the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) amended section 801(m) of the FD&C Act to require a person submitting prior notice of imported food, including food for animals, to report, in addition to other information already required, ``any country to which the article has been refused entry.'' Advance notice of imported food allows FDA, with the support of the U.S. Customs and Border Protection (CBP), to target import inspections more effectively and help protect the nation's food supply against terrorist acts and other public health emergencies. By requiring that a prior notice contain additional information that indicates prior refusals by any country and also identifies the country or countries, the Agency may better identify imported food shipments that may pose safety and security risks to U.S. consumers. This additional knowledge can further help FDA to make better informed decisions in managing the potential risks of imported food shipments into the United States. Any person with knowledge of the required information may submit prior notice for an article of food. Thus, the respondents to this information collection may include importers, owners, ultimate consignees, shippers, and carriers. FDA regulations require that prior notice of imported food be submitted electronically using CBP's Automated Broker Interface of the Automated Commercial System (ABI/ACS) (Sec. 1.280(a)(1)) or the FDA Prior Notice System Interface (PNSI) (Form FDA 3540) (Sec. 1.280(a)(2)). PNSI is an electronic submission system available on the FDA Industry Systems page at https://www.access.fda.gov/. Information the Agency collects in the prior notice submission includes: (1) The submitter and transmitter (if different from the submitter); (2) entry type and CBP identifier; (3) the article of food, including complete FDA product code; (4) the manufacturer, for an article of food no longer in its natural state; (5) the grower, if known, for an article of food that is in its natural state; (6) the FDA Country of Production; (7) the name of any country that has refused entry of the article of food; (8) the shipper, except for food imported by international mail; (9) the country from which the article of food is shipped or, if the food is imported by international mail, the anticipated date of mailing and country from which the food is mailed; (10) the anticipated arrival information or, if the food is imported by [[Page 24132]] international mail, the U.S. recipient; (11) the importer, owner, and ultimate consignee, except for food imported by international mail or transshipped through the United States; (12) the carrier and mode of transportation, except for food imported by international mail; and (13) planned shipment information, except for food imported by international mail (Sec. 1.281). Much of the information collected for prior notice is identical to the information collected for FDA importer's entry notice, which has been approved under OMB control number 0910-0046. The information in an importer's entry notice is collected electronically via CBP's ABI/ACS at the same time the respondent files an entry for import with CBP. To avoid double-counting the burden hours already counted in the importer's entry notice information collection, the burden hour analysis in table 1 reflects FDA's estimate of the reduced burden for prior notice submitted through ABI/ACS in column 6, entitled ``Average Burden per Response.'' In addition to submitting a prior notice, a submitter should cancel a prior notice and must resubmit the information to FDA if information changes after the Agency has confirmed a prior notice submission for review (e.g., if the identity of the manufacturer changes) (Sec. 1.282). However, changes in the estimated quantity, anticipated arrival information, or planned shipment information do not require resubmission of prior notice after the Agency has confirmed a prior notice submission for review (Sec. 1.282(a)(1)(i) to (iii)). In the event that FDA refuses admission to an article of food under section 801(m)(1) or the Agency places it under hold under section 801(l), Sec. Sec. 1.283(d) and 1.285(j) (21 CFR 1.283(d) and 1.285(j)) set forth the procedure for requesting FDA's review and the information required in a request for review. In the event that the Agency places an article of food under hold under section 801(l) of the FD&C Act, Sec. 1.285(i) sets forth the procedure for, and the information to be included in, a post-hold submission. In the Federal Register of January 5, 2017 (82 FR 1349), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received no comments. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR section No. FDA form No. Number of responses per Total annual Average burden per response Total hours respondents respondent responses (hours) -------------------------------------------------------------------------------------------------------------------------------------------------------- Prior Notice Submissions -------------------------------------------------------------------------------------------------------------------------------------------------------- Prior Notice Submitted Through ABI/ACS -------------------------------------------------------------------------------------------------------------------------------------------------------- 1.280-1.281............................... None 1,700 7,647 12,999,900 0.167 (10 minutes).......... \2\ 2,170,983 -------------------------------------------------------------------------------------------------------------------------------------------------------- Prior Notice Submitted Through PNSI -------------------------------------------------------------------------------------------------------------------------------------------------------- 1.280-1.281............................... \3\ 3540 27,000 70 1,890,000 0.384 (23 minutes).......... 725,760 --------------- New Prior Notice Submissions Subtotal. .............. .............. .............. .............. ............................ 2,896,743 -------------------------------------------------------------------------------------------------------------------------------------------------------- Prior Notice Cancellations -------------------------------------------------------------------------------------------------------------------------------------------------------- Prior Notice Cancelled Through ABI/ACS -------------------------------------------------------------------------------------------------------------------------------------------------------- 1.282..................................... 3540 7,040 1 7,040 0.25 (15 minutes)........... 1,760 -------------------------------------------------------------------------------------------------------------------------------------------------------- Prior Notice Cancelled Through PNSI -------------------------------------------------------------------------------------------------------------------------------------------------------- 1.282, 1.283(a)(5)........................ 3540 35,208 1 35,208 0.25 (15 minutes)........... 8,802 --------------- Prior Notice Cancellations Subtotal... .............. .............. .............. .............. ............................ 10,562 -------------------------------------------------------------------------------------------------------------------------------------------------------- Prior Notice Requests for Review and Post-Hold Submissions -------------------------------------------------------------------------------------------------------------------------------------------------------- 1.283(d), 1.285(j),....................... None 1 1 1 8........................... 8 1.285(i).................................. None 263 1 263 1........................... 263 --------------- Prior Notice Requests for Review and .............. .............. .............. .............. ............................ 271 Post-Hold Submissions Subtotal. --------------- Total............................. .............. .............. .............. .............. ............................ 2,907,576 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ To avoid double-counting, an estimated 396,416 burden hours already accounted for in the Importer's Entry Notice information collection approved under OMB control number 0910-0046 are not included in this total. \3\ The term ``Form FDA 3540'' refers to the electronic submission system known as PNSI, which is available at https://www.access.fda.gov/. This estimate is based on FDA's experience and the average number of prior notice submissions, cancellations, and requests for review received in the past 3 years. [[Page 24133]] FDA received 10,450,824 prior notices through ABI/ACS during 2014; 11,282,015 during 2015; and 12,153,880 during 2016. Based on this experience, the Agency estimates that approximately 1,700 users of ABI/ ACS will submit an average of 7,647 prior notices annually, for a total of 12,999,900 prior notices received annually through ABI/ACS. FDA estimates the reporting burden for a prior notice submitted through ABI/ACS to be 10 minutes, or 0.167 hour, per notice, for a total burden of 2,170,983 hours. This estimate takes into consideration the burden hours already counted in the information collection approval for FDA importer's entry notice (OMB control number 0910-0046), as previously discussed. FDA received 1,529,110 prior notices through PNSI during 2014; 1,633,567 during 2015; and 1,768,790 during 2016. Based on this experience, the Agency estimates that approximately 27,000 registered users of PNSI will submit an average of 70 prior notices annually, for a total of 1,890,000 prior notices received annually. FDA estimates the reporting burden for a prior notice submitted through PNSI to be 23 minutes, or 0.384 hour, per notice, for a total burden of 725,760 hours. FDA received 7,265 cancellations of prior notices through ABI/ACS during 2014; 7,910 during 2015; and 5,948 during 2016. Based on this experience, the Agency estimates that approximately 7,040 users of ABI/ ACS will submit an average of 1 cancellation annually, for a total of 7,040 cancellations received annually through ABI/ACS. FDA estimates the reporting burden for a cancellation submitted through ABI/ACS to be 15 minutes, or 0.25 hour, per cancellation, for a total burden of 1,760 hours. FDA received 36,324 cancellations of prior notices through PNSI during 2014; 39,553 during 2015; and 29,743 during 2016. Based on this experience, the Agency estimates that approximately 35,208 registered users of PNSI will submit an average of 1 cancellation annually, for a total of 35,208 cancellations received annually. FDA estimates the reporting burden for a cancellation submitted through PNSI to be 15 minutes, or 0.25 hour, per cancellation, for a total burden of 8,802 hours. FDA has not received any requests for review under Sec. 1.283(d) or Sec. 1.285(j) in the last 3 years; therefore, the Agency estimates that one or fewer requests for review will be submitted annually. FDA estimates that it will take a requestor about 8 hours to prepare the factual and legal information necessary to prepare a request for review. Thus, the Agency has estimated a total reporting burden of 8 hours. FDA received 235 post-hold submissions under Sec. 1.285(i) during 2014; 218 during 2015; and 337 during 2016. Based on this experience, the Agency estimates that 263 post-hold submissions under Sec. 1.285(i) will be submitted annually. FDA estimates that it will take about 1 hour to prepare the written notification described in Sec. 1.285(i)(2)(i). Thus, the Agency estimates a total reporting burden of 263 hours. Dated: May 18, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-10712 Filed 5-24-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Notices 24131
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control Date approval
Title of collection No. expires
Procedures for the Safe Processing and Importing of Fish and Fishery Products ................................................ 0910–0354 2/29/2020
Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and
Tissue-Based Product Deviations; Form FDA 3486 and Addendum, 3486A ..................................................... 0910–0458 2/29/2020
Designation of New Animal Drugs for Minor Use or Minor Species ....................................................................... 0910–0605 2/29/2020
Unique Device Identification System ....................................................................................................................... 0910–0720 2/29/2020
Animal Feed Regulatory Program Standards ......................................................................................................... 0910–0760 2/29/2020
Premarket Approval of Medical Devices—21 CFR Part 814 .................................................................................. 0910–0231 3/31/2020
Human Tissue Intended for Transplantation ........................................................................................................... 0910–0302 3/31/2020
General Licensing Provisions: Biological License Application, Changes to an Approved Application, Labeling,
Revocation and Suspension, and Form FDA 356h ............................................................................................. 0910–0338 3/31/2020
Dated: May 18, 2017. and Drug Administration, Three White other public health emergencies. By
Anna K. Abram, Flint North, 10A63, 11601 Landsdown requiring that a prior notice contain
Deputy Commissioner for Policy, Planning, St., North Bethesda, MD 20852, 301– additional information that indicates
Legislative, and Analysis. 796–7726, PRAStaff@fda.hhs.gov. prior refusals by any country and also
[FR Doc. 2017–10736 Filed 5–24–17; 8:45 am] SUPPLEMENTARY INFORMATION: In identifies the country or countries, the
BILLING CODE 4164–01–P compliance with 44 U.S.C. 3507, FDA Agency may better identify imported
has submitted the following proposed food shipments that may pose safety
collection of information to OMB for and security risks to U.S. consumers.
DEPARTMENT OF HEALTH AND review and clearance. This additional knowledge can further
HUMAN SERVICES help FDA to make better informed
Prior Notice of Imported Food Under decisions in managing the potential
Food and Drug Administration the Public Health Security and risks of imported food shipments into
Bioterrorism Preparedness and the United States.
[Docket No. FDA–2010–N–0118]
Response Act of 2002—21 CFR 1.278 to Any person with knowledge of the
Agency Information Collection 1.285, OMB Control Number 0910–0520 required information may submit prior
Activities; Submission for Office of The Public Health Security and notice for an article of food. Thus, the
Management and Budget Review; Bioterrorism Preparedness and respondents to this information
Comment Request; Prior Notice of Response Act of 2002 (the Bioterrorism collection may include importers,
Imported Food Under the Public Health Act) added section 801(m) of the owners, ultimate consignees, shippers,
Security and Bioterrorism Federal Food, Drug, and Cosmetic Act and carriers.
Preparedness and Response Act of (the FD&C Act) (21 U.S.C. 381(m)), FDA regulations require that prior
2002 which requires that FDA receives prior notice of imported food be submitted
AGENCY: Food and Drug Administration, notice for food, including food for electronically using CBP’s Automated
HHS. animals, that is imported or offered for Broker Interface of the Automated
import into the United States. Sections Commercial System (ABI/ACS)
ACTION: Notice. 1.278 to 1.282 of FDA regulations (21 (§ 1.280(a)(1)) or the FDA Prior Notice
SUMMARY: The Food and Drug CFR 1.278 to 1.282) set forth the System Interface (PNSI) (Form FDA
Administration (FDA) is announcing requirements for submitting prior 3540) (§ 1.280(a)(2)). PNSI is an
that a proposed collection of notice; §§ 1.283(d) and 1.285(j) (21 CFR electronic submission system available
information has been submitted to the 1.283(d) and 1.285(j)) set forth the on the FDA Industry Systems page at
Office of Management and Budget procedure for requesting the Agency https://www.access.fda.gov/.
(OMB) for review and clearance under review after FDA has refused admission Information the Agency collects in the
the Paperwork Reduction Act of 1995. of an article of food under section prior notice submission includes: (1)
DATES: Fax written comments on the
801(m)(1) of the FD&C Act or placed an The submitter and transmitter (if
collection of information by June 26, article of food under hold under section different from the submitter); (2) entry
2017. 801(l); and § 1.285(i) sets forth the type and CBP identifier; (3) the article
procedure for post-hold submissions. of food, including complete FDA
ADDRESSES: To ensure that comments on Section 304 of the FDA Food Safety product code; (4) the manufacturer, for
the information collection are received, Modernization Act (FSMA) (Pub. L. an article of food no longer in its natural
OMB recommends that written 111–353) amended section 801(m) of the state; (5) the grower, if known, for an
comments be faxed to the Office of FD&C Act to require a person submitting article of food that is in its natural state;
Information and Regulatory Affairs, prior notice of imported food, including (6) the FDA Country of Production; (7)
OMB, Attn: FDA Desk Officer, FAX: food for animals, to report, in addition the name of any country that has
202–395–7285, or emailed to oira_ to other information already required, refused entry of the article of food; (8)
submission@omb.eop.gov. All ‘‘any country to which the article has the shipper, except for food imported by
comments should be identified with the been refused entry.’’ international mail; (9) the country from
OMB control number 0910–0520. Also Advance notice of imported food which the article of food is shipped or,
include the FDA docket number found allows FDA, with the support of the if the food is imported by international
in brackets in the heading of this U.S. Customs and Border Protection mail, the anticipated date of mailing and
document. (CBP), to target import inspections more country from which the food is mailed;
FOR FURTHER INFORMATION CONTACT: Ila effectively and help protect the nation’s (10) the anticipated arrival information
S. Mizrachi, Office of Operations, Food food supply against terrorist acts and or, if the food is imported by
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![Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Notices 24133
FDA received 10,450,824 prior notices request for review. Thus, the Agency DATES: Submit either electronic or
through ABI/ACS during 2014; has estimated a total reporting burden of written comments on the collection of
11,282,015 during 2015; and 12,153,880 8 hours. information by July 24, 2017.
during 2016. Based on this experience, FDA received 235 post-hold ADDRESSES: You may submit comments
the Agency estimates that submissions under § 1.285(i) during as follows:
approximately 1,700 users of ABI/ACS 2014; 218 during 2015; and 337 during
will submit an average of 7,647 prior 2016. Based on this experience, the Electronic Submissions
notices annually, for a total of Agency estimates that 263 post-hold Submit electronic comments in the
12,999,900 prior notices received submissions under § 1.285(i) will be following way:
annually through ABI/ACS. FDA submitted annually. FDA estimates that • Federal eRulemaking Portal:
estimates the reporting burden for a it will take about 1 hour to prepare the https://www.regulations.gov. Follow the
prior notice submitted through ABI/ACS written notification described in instructions for submitting comments.
to be 10 minutes, or 0.167 hour, per § 1.285(i)(2)(i). Thus, the Agency Comments submitted electronically,
notice, for a total burden of 2,170,983 estimates a total reporting burden of 263 including attachments, to https://
hours. This estimate takes into hours. www.regulations.gov will be posted to
consideration the burden hours already the docket unchanged. Because your
Dated: May 18, 2017.
counted in the information collection comment will be made public, you are
Anna K. Abram, solely responsible for ensuring that your
approval for FDA importer’s entry
notice (OMB control number 0910– Deputy Commissioner for Policy, Planning, comment does not include any
Legislation, and Analysis. confidential information that you or a
0046), as previously discussed.
FDA received 1,529,110 prior notices [FR Doc. 2017–10712 Filed 5–24–17; 8:45 am] third party may not wish to be posted,
through PNSI during 2014; 1,633,567 BILLING CODE 4164–01–P such as medical information, your or
during 2015; and 1,768,790 during 2016. anyone else’s Social Security number, or
Based on this experience, the Agency confidential business information, such
estimates that approximately 27,000 DEPARTMENT OF HEALTH AND as a manufacturing process. Please note
registered users of PNSI will submit an HUMAN SERVICES that if you include your name, contact
average of 70 prior notices annually, for information, or other information that
a total of 1,890,000 prior notices Food and Drug Administration
identifies you in the body of your
received annually. FDA estimates the [Docket No. FDA–2008–N–0094] comments, that information will be
reporting burden for a prior notice posted on https://www.regulations.gov.
submitted through PNSI to be 23 Agency Information Collection • If you want to submit a comment
minutes, or 0.384 hour, per notice, for Activities; Proposed Collection; with confidential information that you
a total burden of 725,760 hours. Comment Request; Channels of Trade do not wish to be made available to the
FDA received 7,265 cancellations of Policy for Commodities With Residues public, submit the comment as a
prior notices through ABI/ACS during of Pesticide Chemicals, for Which written/paper submission and in the
2014; 7,910 during 2015; and 5,948 Tolerances Have Been Revoked, manner detailed (see ‘‘Written/Paper
during 2016. Based on this experience, Suspended, or Modified by the Submissions’’ and ‘‘Instructions’’).
the Agency estimates that Environmental Protection Agency
approximately 7,040 users of ABI/ACS Written/Paper Submissions
Pursuant to Dietary Risk
will submit an average of 1 cancellation Considerations Submit written/paper submissions as
annually, for a total of 7,040 follows:
cancellations received annually through AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
ABI/ACS. FDA estimates the reporting HHS. written/paper submissions): Division of
burden for a cancellation submitted ACTION: Notice. Dockets Management (HFA–305), Food
through ABI/ACS to be 15 minutes, or and Drug Administration, 5630 Fishers
0.25 hour, per cancellation, for a total SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852.
burden of 1,760 hours. Administration (FDA or Agency) is • For written/paper comments
FDA received 36,324 cancellations of announcing an opportunity for public submitted to the Division of Dockets
prior notices through PNSI during 2014; comment on the proposed collection of Management, FDA will post your
39,553 during 2015; and 29,743 during certain information by the Agency. comment, as well as any attachments,
2016. Based on this experience, the Under the Paperwork Reduction Act of except for information submitted,
Agency estimates that approximately 1995 (PRA), Federal Agencies are marked and identified, as confidential,
35,208 registered users of PNSI will required to publish notice in the if submitted as detailed in
submit an average of 1 cancellation Federal Register concerning each ‘‘Instructions.’’
annually, for a total of 35,208 proposed collection of information, Instructions: All submissions received
cancellations received annually. FDA including each proposed extension/ must include the Docket No. FDA–
estimates the reporting burden for a reinstatement of an existing collection 2008–N–0094 for ‘‘Agency Information
cancellation submitted through PNSI to of information, and to allow 60 days for Collection Activities; Proposed
be 15 minutes, or 0.25 hour, per public comment in response to the Collection; Comment Request; Channels
cancellation, for a total burden of 8,802 notice. This notice solicits comments on of Trade Policy for Commodities With
hours. the information collection provisions of Residues of Pesticide Chemicals, for
FDA has not received any requests for FDA’s guidance for industry entitled Which Tolerances Have Been Revoked,
review under § 1.283(d) or § 1.285(j) in ‘‘Channels of Trade Policy for Suspended, or Modified by the
the last 3 years; therefore, the Agency Commodities With Residues of Pesticide Environmental Protection Agency
estimates that one or fewer requests for Chemicals, for Which Tolerances Have Pursuant to Dietary Risk
review will be submitted annually. FDA Been Revoked, Suspended, or Modified Considerations.’’ Received comments
estimates that it will take a requestor by the Environmental Protection Agency will be placed in the docket and, except
about 8 hours to prepare the factual and Pursuant to Dietary Risk for those submitted as ‘‘Confidential
legal information necessary to prepare a Considerations.’’ Submissions,’’ publicly viewable at
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Document Created: 2018-11-08 08:52:31
Document Modified: 2018-11-08 08:52:31
| 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 | Fax written comments on the collection of information by June 26, 2017. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 82 FR 24131 |
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