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, 24131-24133 [2017-10712]

Download as PDF Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Notices 24131 TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB OMB control No. Title of collection Procedures for the Safe Processing and Importing of Fish and Fishery Products ................................................ Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations; Form FDA 3486 and Addendum, 3486A ..................................................... Designation of New Animal Drugs for Minor Use or Minor Species ....................................................................... Unique Device Identification System ....................................................................................................................... Animal Feed Regulatory Program Standards ......................................................................................................... Premarket Approval of Medical Devices—21 CFR Part 814 .................................................................................. Human Tissue Intended for Transplantation ........................................................................................................... General Licensing Provisions: Biological License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Form FDA 356h ............................................................................................. Dated: May 18, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislative, and Analysis. and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301– 796–7726, PRAStaff@fda.hhs.gov. 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. [FR Doc. 2017–10736 Filed 5–24–17; 8:45 am] BILLING CODE 4164–01–P 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. 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. SUMMARY: 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 oira_ submission@omb.eop.gov. 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. ADDRESSES: Ila S. Mizrachi, Office of Operations, Food FOR FURTHER INFORMATION CONTACT: VerDate Sep<11>2014 18:04 May 24, 2017 Jkt 241001 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; §§ 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 § 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 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Date approval expires 0910–0354 2/29/2020 0910–0458 0910–0605 0910–0720 0910–0760 0910–0231 0910–0302 2/29/2020 2/29/2020 2/29/2020 2/29/2020 3/31/2020 3/31/2020 0910–0338 3/31/2020 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) (§ 1.280(a)(1)) or the FDA Prior Notice System Interface (PNSI) (Form FDA 3540) (§ 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 E:\FR\FM\25MYN1.SGM 25MYN1 24132 Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Notices 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 (§ 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 doublecounting 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) (§ 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 (§ 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), §§ 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, § 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 60day 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 21 CFR section No. FDA form No. Number of respondents Number of responses per respondent Total annual responses Average burden per response (hours) Total 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 3 3540 27,000 70 1,890,000 0.384 (23 minutes) ............. 725,760 ........................ ........................ ........................ ........................ ............................................. 2,896,743 0.25 (15 minutes) ............... 1,760 1.280–1.281 ........................ New Prior Notice Submissions Subtotal. Prior Notice Cancellations Prior Notice Cancelled Through ABI/ACS 1.282 ................................... 3540 7,040 1 7,040 Prior Notice Cancelled Through PNSI 1.282, 1.283(a)(5) ............... Prior Notice Cancellations Subtotal. 3540 35,208 1 35,208 0.25 (15 minutes) ............... 8,802 ........................ ........................ ........................ ........................ ............................................. 10,562 Prior Notice Requests for Review and Post-Hold Submissions 1.283(d), 1.285(j), ............... 1.285(i) ................................ Prior Notice Requests for Review and PostHold Submissions Subtotal. Total ...................... None None 1 263 1 1 1 263 8 ......................................... 1 ......................................... 8 263 ........................ ........................ ........................ ........................ ............................................. 271 ........................ ........................ ........................ ........................ ............................................. 2,907,576 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 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/. 2 To This estimate is based on FDA’s experience and the average number of VerDate Sep<11>2014 18:04 May 24, 2017 Jkt 241001 prior notice submissions, cancellations, PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 and requests for review received in the past 3 years. E:\FR\FM\25MYN1.SGM 25MYN1 Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Notices 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 § 1.283(d) or § 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 VerDate Sep<11>2014 18:04 May 24, 2017 Jkt 241001 request for review. Thus, the Agency has estimated a total reporting burden of 8 hours. FDA received 235 post-hold submissions under § 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 § 1.285(i) will be submitted annually. FDA estimates that it will take about 1 hour to prepare the written notification described in § 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0094] Agency Information Collection Activities; Proposed Collection; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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/ reinstatement 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 of FDA’s guidance for industry entitled ‘‘Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.’’ SUMMARY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 24133 Submit either electronic or written comments on the collection of information by July 24, 2017. ADDRESSES: You may submit comments as follows: DATES: 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): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2008–N–0094 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at E:\FR\FM\25MYN1.SGM 25MYN1

Agencies

[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)]
[Notices]
[Pages 24131-24133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 oira_submission@omb.eop.gov. 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,
PRAStaff@fda.hhs.gov.

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

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