82 FR 1349 - Agency Information Collection Activities; Proposed Collection; 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 3 (January 5, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 3 (January 5, 2017)
| Page Range | 1349-1352 | |
| FR Document | 2016-32030 |
[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)] [Notices] [Pages 1349-1352] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-32030] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0118] Agency Information Collection Activities; Proposed Collection; 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 or the 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 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA regulations requiring that the Agency receives prior notice before food is imported or offered for import into the United States. DATES: Submit either electronic or written comments on the collection of information by March 6, 2017. ADDRESSES: You may submit comments as follows: 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-2010-N-0118 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 [[Page 1350]] claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. 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--Revision 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 (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) of the FD&C Act; 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 http://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 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 [[Page 1351]] 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) of the FD&C Act, 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 Sec. 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. 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 7647 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 .............. .............. .............. .............. .................................. 2,896,743 Subtotal. -------------------------------------------------------------------------------------------------------------------------------------------------------- Prior Notice Cancellations -------------------------------------------------------------------------------------------------------------------------------------------------------- Prior Notice Cancelled Through ABI/ACS -------------------------------------------------------------------------------------------------------------------------------------------------------- 1.282............................... 3540 7,040 1 7,040 0.25 (15 minutes)................. 1760 -------------------------------------------------------------------------------------------------------------------------------------------------------- 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 .............. .............. .............. .............. .................................. 10,562 Subtotal. -------------------------------------------------------------------------------------------------------------------------------------------------------- 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 .............. .............. .............. .............. .................................. 271 and 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 http://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. 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. [[Page 1352]] 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: December 30, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-32030 Filed 1-4-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices 1349
Consultation Policy issued in February II. Electronic Access comment will be made public, you are
2016. Persons with access to the Internet solely responsible for ensuring that your
may obtain the document at either comment does not include any
ADDRESSES: For access to the docket to confidential information that you or a
read background documents or the http://www.fda.gov/tribal or https://
www.regulations.gov. Use the FDA Web third party may not wish to be posted,
electronic and written/paper comments such as medical information, your or
received, go to https:// site listed in the previous sentence to
find the most current version of the anyone else’s Social Security number, or
www.regulations.gov and insert the confidential business information, such
docket number, found in brackets in the document.
as a manufacturing process. Please note
heading of this document, into the Dated: December 29, 2016. that if you include your name, contact
‘‘Search’’ box and follow the prompts Leslie Kux, information, or other information that
and/or go to the Division of Dockets Associate Commissioner for Policy. identifies you in the body of your
Management, 5630 Fishers Lane, Rm. [FR Doc. 2016–31951 Filed 1–4–17; 8:45 am] comments, that information will be
1061, Rockville, MD 20852. posted on https://www.regulations.gov.
BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT: • If you want to submit a comment
Sarah Walinsky, Food and Drug with confidential information that you
Administration, 10903 New Hampshire DEPARTMENT OF HEALTH AND do not wish to be made available to the
Ave., Silver Spring, MD 20993, (240) HUMAN SERVICES public, submit the comment as a
402–4075. written/paper submission and in the
Food and Drug Administration manner detailed (see ‘‘Written/Paper
SUPPLEMENTARY INFORMATION: Submissions’’ and ‘‘Instructions’’).
[Docket No. FDA–2010–N–0118]
I. Background Written/Paper Submissions
Agency Information Collection
Under Executive Order 13175 of Activities; Proposed Collection; Submit written/paper submissions as
November 6, 2000, executive Comment Request; Prior Notice of follows:
departments and Agencies are charged • Mail/Hand delivery/Courier (for
Imported Food Under the Public Health
with engaging in regular and meaningful written/paper submissions): Division of
Security and Bioterrorism
consultation and collaboration with Dockets Management (HFA–305), Food
Preparedness and Response Act of
Indian tribal governments in the and Drug Administration, 5630 Fishers
2002
development of Federal policies that Lane, Rm. 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration, • For written/paper comments
have tribal implications and are
HHS. submitted to the Division of Dockets
responsible for strengthening the
ACTION: Notice. Management, FDA will post your
government-to-government relationship
comment, as well as any attachments,
between the United States and Indian SUMMARY: The Food and Drug except for information submitted,
Tribes. The HHS Tribal Consultation Administration (FDA or the Agency) is marked and identified, as confidential,
Policy, revised on December 14, 2010, announcing an opportunity for public if submitted as detailed in
further clarifies that each HHS comment on the proposed collection of ‘‘Instructions.’’
Operating and Staff Division must have certain information by the Agency. Instructions: All submissions received
an accountable consultation process to Under the Paperwork Reduction Act of must include the Docket No. FDA–
ensure meaningful and timely input by 1995 (the PRA), Federal Agencies are 2010–N–0118 for ‘‘Agency Information
tribal officials in the development of required to publish notice in the Collection Activities; Proposed
policies that have tribal implications. Federal Register concerning each Collection; Comment Request; Prior
The FDA Tribal Consultation Policy, proposed collection of information, Notice of Imported Food Under the
which finalizes the draft FDA Tribal including each proposed extension of an Public Health Security and Bioterrorism
Consultation Policy issued in February existing collection of information, and Preparedness and Response Act of
2016, is based on the HHS Tribal to allow 60 days for public comment in 2002.’’ Received comments will be
Consultation Policy and includes response to the notice. This notice placed in the docket and, except for
Agency-specific consultation guidelines solicits comments on the information those submitted as ‘‘Confidential
that complement the Department-wide collection provisions of FDA regulations Submissions,’’ publicly viewable at
efforts. requiring that the Agency receives prior https://www.regulations.gov or at the
The purpose of the FDA Tribal notice before food is imported or offered Division of Dockets Management
Consultation Policy is to further the for import into the United States. between 9 a.m. and 4 p.m., Monday
government-to-government relationship DATES: Submit either electronic or through Friday.
between FDA and Indian Tribes and written comments on the collection of • Confidential Submissions—To
facilitate tribal consultation with FDA. information by March 6, 2017. submit a comment with confidential
The policy provides background on ADDRESSES: You may submit comments information that you do not wish to be
FDA’s mission and organizational as follows: made publicly available, submit your
structure and elaborates on the comments only as a written/paper
principles and guidelines in the HHS Electronic Submissions submission. You should submit two
Tribal Consultation Policy. We Submit electronic comments in the copies total. One copy will include the
consulted with Indian Tribes on the following way: information you claim to be confidential
mstockstill on DSK3G9T082PROD with NOTICES
FDA Tribal Consultation Policy, which • Federal eRulemaking Portal: with a heading or cover note that states
is intended to serve as a platform for the https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
Agency to create consistent and instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
meaningful tribal consultation across Comments submitted electronically, Agency will review this copy, including
FDA Centers and Offices. A copy of the including attachments, to https:// the claimed confidential information, in
final policy has also been shared with www.regulations.gov will be posted to its consideration of comments. The
Indian Tribes in a letter to tribal leaders. the docket unchanged. Because your second copy, which will have the
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![1352 Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices
FDA received 7,265 cancellations of DEPARTMENT OF HEALTH AND following: The NHSC LRP Application,
prior notices through ABI/ACS during HUMAN SERVICES the Authorization for Disclosure of Loan
2014; 7,910 during 2015; and 5,948 Information form, the Privacy Act
during 2016. Based on this experience, Health Resources and Services Release Authorization form, and if
the Agency estimates that Administration applicable, the Verification of
approximately 7,040 users of ABI/ACS Disadvantaged Background form and the
Agency Information Collection Private Practice Option form. The first
will submit an average of 1 cancellation Activities: Submission to OMB for
annually, for a total of 7,040 four of the aforementioned NHSC LRP
Review and Approval; Public Comment forms collect information that is needed
cancellations received annually through Request; The National Health Service for selecting participants and repaying
ABI/ACS. FDA estimates the reporting Corps Loan Repayment Program qualifying educational loans. The last
burden for a cancellation submitted
AGENCY: Health Resources and Services referenced form, the Private Practice
through ABI/ACS to be 15 minutes, or Option Form, is needed to collect
0.25 hour, per cancellation, for a total Administration (HRSA), Department of
Health and Human Services. information for all participants who
burden of 1,760 hours. have applied for that service option.
ACTION: Notice.
FDA received 36,324 cancellations of NHSC-approved sites are health care
prior notices through PNSI during 2014; SUMMARY: In compliance with Section facilities that provide comprehensive
39,553 during 2015; and 29,743 during 3507(a)(1)(D) of the Paperwork outpatient, ambulatory, primary health
2016. Based on this experience, the Reduction Act of 1995, HRSA has care services to populations residing in
Agency estimates that approximately submitted an Information Collection HPSAs. Related in-patient services may
35,208 registered users of PNSI will Request (ICR) to the Office of be provided by NHSC-approved Critical
submit an average of 1 cancellation Management and Budget (OMB) for Access Hospitals (CAHs). To become an
annually, for a total of 35,208 review and approval. Comments NHSC-approved site, new sites must
submitted during the first public review submit a Site Application for review
cancellations received annually. FDA
of this ICR will be provided to OMB. and approval. Existing NHSC-approved
estimates the reporting burden for a
OMB will accept further comments from sites are required to complete a Site
cancellation submitted through PNSI to Recertification Application to maintain
be 15 minutes, or 0.25 hour, per the public during the review and
approval period. their NHSC-approved status. Both the
cancellation, for a total burden of 8,802 NHSC Site Application and Site
hours. DATES: Comments on this ICR should be
received no later than February 6, 2017. Recertification Application request
FDA has not received any requests for information on the clinical service site,
ADDRESSES: Submit your comments,
review under § 1.283(d) or § 1.285(j) in sponsoring agency, recruitment contact,
including the ICR Title, to the desk staffing levels, service users, charges for
the last 3 years; therefore, the Agency officer for HRSA, either by email to
estimates that one or fewer requests for services, employment policies, and
OIRA_submission@omb.eop.gov or by fiscal management capabilities.
review will be submitted annually. FDA fax to 202–395–5806.
estimates that it will take a requestor Assistance in completing these
FOR FURTHER INFORMATION CONTACT: To applications may be obtained through
about 8 hours to prepare the factual and request a copy of the clearance requests
legal information necessary to prepare a the appropriate State Primary Care
submitted to OMB for review, email the Offices and HRSA’s NHSC program
request for review. Thus, the Agency HRSA Information Collection Clearance office. The information collected on the
has estimated a total reporting burden of Officer at paperwork@hrsa.gov or call applications is used for determining the
8 hours. (301) 443–1984. eligibility of sites for the assignment of
FDA received 235 post-hold SUPPLEMENTARY INFORMATION: When NHSC health professionals and to verify
submissions under § 1.285(i) during submitting comments or requesting the need for NHSC clinicians. NHSC
2014; 218 during 2015; and 337 during information, please include the service site approval is valid for 3 years.
2016. Based on this experience, the information request collection title for Sites wishing to remain eligible for the
Agency estimates that 263 post-hold reference. assignment of NHSC providers must
submissions under § 1.285(i) will be Information Collection Request Title: submit a Site Recertification
submitted annually. FDA estimates that The National Health Service Corps Loan Application every 3 years.
it will take about 1 hour to prepare the Repayment Program. The proposed ICR is a revision to
OMB No. 0915–0127 Revision. OMB control number 0915–0127 (NHSC
written notification described in
Abstract: The National Health Service LRP) by combining previously approved
§ 1.285(i)(2)(i). Thus, the Agency Corps (NHSC) Loan Repayment Program OMB number 0915–0230 (NHSC Site
estimates a total reporting burden of 263 (LRP) was established to assure an Application and Site Recertification
hours. adequate supply of trained primary care Application forms) and adding a new
Dated: December 30, 2016. health professionals to provide services form to the ICR called the NHSC
Leslie Kux, in the neediest Health Professional Comprehensive Behavioral Health
Associate Commissioner for Policy. Shortage Areas (HPSAs) of the United Services Checklist.
States. Under this program, the Need and Proposed Use of the
[FR Doc. 2016–32030 Filed 1–4–17; 8:45 am]
Department of Health and Human Information: The need and purpose of
BILLING CODE 4164–01–P
Services agrees to repay the qualifying this information collection is to obtain
educational loans of selected primary information that is used to assess an
mstockstill on DSK3G9T082PROD with NOTICES
care health professionals. In return, the LRP applicant’s eligibility and
health professionals agree to serve for a qualifications for the LRP and obtain
specified period of time in an NHSC- information for NHSC site applicants.
approved site located in a federally- Clinicians interested in participating in
designated HPSA approved by the the NHSC LRP must submit an
Secretary for LRP participants. The application to the NHSC to participate
forms used by the LRP include the in the program, and health care facilities
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Document Created: 2018-02-01 14:51:19
Document Modified: 2018-02-01 14:51:19
| 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 March 6, 2017. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 82 FR 1349 |
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