83 FR 22984 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Cosmetic Export Certificate Application Process
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 96 (May 17, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 96 (May 17, 2018)
| Page Range | 22984-22985 | |
| FR Document | 2018-10551 |
[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)] [Notices] [Pages 22984-22985] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10551] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-2347] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Cosmetic Export Certificate Application Process AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 18, 2018. 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 0910-0793. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 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. Food and Cosmetic Export Certificate Application Process OMB Control Number 0910-0793--Revision This information collection supports FDA's Center for Food Safety and Applied Nutrition's (CFSAN) export certificate application process. Some countries may require manufacturers of FDA-regulated products to provide certificates for products they wish to export to that country. Accordingly, firms exporting products from the United States often ask FDA to provide such a ``certificate.'' In many cases, foreign governments are seeking official assurance that products exported to their countries can be marketed in the United States, or that they meet specific U.S. requirements. In some cases, review of an FDA export certificate may be required as part of the process to register or import a product into another country. An export certificate generally indicates that the particular product is marketed in the United States or otherwise eligible for export and that the particular manufacturer has no unresolved enforcement actions pending before, or taken by, FDA. Interested persons may request a certificate from CFSAN electronically via the Certificate Application Process (CAP), a component of FDA Industry Systems, or by contacting CFSAN for assistance. To facilitate the application process we have eliminated paper-based forms. For food products, we have expanded the electronic options for providing facility and product information. Respondents will now be able to identify facilities based on a food facility registration number, FDA Establishment Identification number, or Data Universal Numbering System number. The system uses these identifiers to locate and auto-populate name and address information, eliminating the need for users to manually enter this information and reducing the time to complete the application. Respondents can also upload product information via a spreadsheet, which reduces the time needed to enter product information, particularly for applications that include multiple products. All information is entered using electronic Forms FDA 3613d, 3613e, 3613g, and 3613l and used to evaluate certificate requests. While burden associated with information collection activities for export certificates issued for other FDA-regulated products is approved under OMB control number 0910-0498, this collection specifically supports export certificates issued by CFSAN. Also, because we have eliminated paper-based forms, respondents who require assistance with completing export certificate applications online may contact CFSAN directly by email (CFSANExportCertification@fda.hhs.gov) or telephone (240-402-2307). Instructions for Form FDA 3613d are available online at https://www.fda.gov/cosmetics/internationalactivities/exporters/ucm353912.htm and instructions for Form FDA 3613e are available online at https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/ucm260280.htm. Draft screenshots of Form FDA 3613g and 3613l are available for comment online at https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/default.htm. Description of Respondents: The respondents to this collection of information are firms interested in exporting U.S.-manufactured food and cosmetic products to foreign countries that require export certificates. In the Federal Register of January 2, 2018 (83 FR 133), we published a notice soliciting public comment of the information collection. Two comments were received in support of the information collection. One comment included technical suggestions as well regarding respondents' ability to review and edit data that might have been entered improperly. We appreciate this comment and continue to seek ways to utilize improved information collection [[Page 22985]] technologies as our resources permit. FDA notes section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) also provides that FDA may charge a fee of up to $175 if the Agency issues a certificate within 20 days of receipt of a complete request for such a certificate. This fee may vary depending on the product type, but it will not exceed $175. We estimate the burden of the information collection as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Type of respondent FDA Form No.\2\ Number of responses per Total annual Average burden per Total hours respondents respondent responses response (in hours) -------------------------------------------------------------------------------------------------------------------------------------------------------- Cosmetics............................ 3613d................... 270 3 810 0.5 (30 minutes)....... 405 Food................................. 3613e, 3613g, 3613l..... 881 5 4,405 0.5 (30 minutes)....... 2,203 ---------------------------------------------------------------------------------------- Total............................ ........................ .............. .............. .............. ....................... 2,608 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ All forms are submitted electronically via CAP. This estimate reflects a revision resulting from the elimination of paper-based forms. Specifically, and based on our experience with the information collection, we have reduced the estimated time to prepare a submission from 1.5 hours to 0.5 hour. The previous estimate was based on the time necessary to prepare a paper submission, but all firms requesting export certificates now provide submissions electronically via CAP. We believe that the time to prepare an electronic submission is under 0.25 hour, but are estimating 0.5 hour as a conservative approach to address all scenarios. We base our estimates of the total annual responses on our experience with certificate applications received in the past 3 fiscal years. We expect that most firms requesting export certificates in the next 3 years will choose to take advantage of the option of electronic submission via CAP. If a firm is unable to submit their information via CAP, they may contact CFSAN and request assistance. CFSAN will assist firms in entering their information into the electronic system so that the firm may receive their export certificates in a timely manner. Our burden estimates in table 1 are based on the expectation of 100 percent participation in the electronic submission process. Providing the opportunity to submit the information in electronic format has reduced our previous estimates for the time to prepare each submission. Dated: May 14, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-10551 Filed 5-16-18; 8:45 am] BILLING CODE 4164-01-P
![22984 Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Notices
2018. Time allotted for each DATES: Fax written comments on the expanded the electronic options for
presentation may be limited. If the collection of information by June 18, providing facility and product
number of registrants requesting to 2018. information. Respondents will now be
speak is greater than can be reasonably ADDRESSES: To ensure that comments on able to identify facilities based on a food
accommodated during the scheduled the information collection are received, facility registration number, FDA
open public hearing session, FDA may OMB recommends that written Establishment Identification number, or
conduct a lottery to determine the comments be faxed to the Office of Data Universal Numbering System
speakers for the scheduled open public Information and Regulatory Affairs, number. The system uses these
hearing session. The contact person will OMB, Attn: FDA Desk Officer, Fax: 202– identifiers to locate and auto-populate
notify interested persons regarding their 395–7285, or emailed to oira_ name and address information,
request to speak by May 31, 2018. submission@omb.eop.gov. All eliminating the need for users to
Persons attending FDA’s advisory comments should be identified with the manually enter this information and
committee meetings are advised that the OMB control number 0910–0793. Also reducing the time to complete the
Agency is not responsible for providing application. Respondents can also
include the FDA docket number found
access to electrical outlets. upload product information via a
in brackets in the heading of this
FDA welcomes the attendance of the spreadsheet, which reduces the time
document.
public at its advisory committee needed to enter product information,
FOR FURTHER INFORMATION CONTACT: particularly for applications that
meetings and will make every effort to
Domini Bean, Office of Operations, include multiple products. All
accommodate persons with disabilities.
Food and Drug Administration, Three information is entered using electronic
If you require accommodations due to a
White Flint North, 10A–12M, 11601 Forms FDA 3613d, 3613e, 3613g, and
disability, please contact Artair Mallett
Landsdown St., North Bethesda, MD 3613l and used to evaluate certificate
at Artair.Mallett@fda.hhs.gov or 301–
20852, 301–796–5733, PRAStaff@ requests.
796–9638 at least 7 days in advance of
fda.hhs.gov. While burden associated with
the meeting.
SUPPLEMENTARY INFORMATION: In information collection activities for
FDA is committed to the orderly
compliance with 44 U.S.C. 3507, FDA export certificates issued for other FDA-
conduct of its advisory committee
has submitted the following proposed regulated products is approved under
meetings. Please visit our website at
collection of information to OMB for OMB control number 0910–0498, this
https://www.fda.gov/
review and clearance. collection specifically supports export
AdvisoryCommittees/
certificates issued by CFSAN. Also,
AboutAdvisoryCommittees/ Food and Cosmetic Export Certificate because we have eliminated paper-
ucm111462.htm for procedures on Application Process based forms, respondents who require
public conduct during advisory
OMB Control Number 0910–0793— assistance with completing export
committee meetings.
Revision certificate applications online may
Notice of this meeting is given under contact CFSAN directly by email
the Federal Advisory Committee Act (5 This information collection supports (CFSANExportCertification@
U.S.C. app. 2). FDA’s Center for Food Safety and fda.hhs.gov) or telephone (240–402–
Dated: May 10, 2018. Applied Nutrition’s (CFSAN) export 2307). Instructions for Form FDA 3613d
Leslie Kux, certificate application process. Some are available online at https://
Associate Commissioner for Policy.
countries may require manufacturers of www.fda.gov/cosmetics/
FDA-regulated products to provide internationalactivities/exporters/
[FR Doc. 2018–10552 Filed 5–16–18; 8:45 am]
certificates for products they wish to ucm353912.htm and instructions for
BILLING CODE 4164–01–P
export to that country. Accordingly, Form FDA 3613e are available online at
firms exporting products from the https://www.fda.gov/Food/
DEPARTMENT OF HEALTH AND United States often ask FDA to provide GuidanceRegulation/ImportsExports/
HUMAN SERVICES such a ‘‘certificate.’’ In many cases, Exporting/ucm260280.htm. Draft
foreign governments are seeking official screenshots of Form FDA 3613g and
Food and Drug Administration assurance that products exported to 3613l are available for comment online
their countries can be marketed in the at https://www.fda.gov/Food/
United States, or that they meet specific GuidanceRegulation/ImportsExports/
[Docket No. FDA–2014–N–2347]
U.S. requirements. In some cases, Exporting/default.htm.
Agency Information Collection review of an FDA export certificate may Description of Respondents: The
Activities; Submission for Office of be required as part of the process to respondents to this collection of
Management and Budget Review; register or import a product into another information are firms interested in
Comment Request; Food and country. An export certificate generally exporting U.S.-manufactured food and
Cosmetic Export Certificate indicates that the particular product is cosmetic products to foreign countries
Application Process marketed in the United States or that require export certificates.
otherwise eligible for export and that In the Federal Register of January 2,
AGENCY: Food and Drug Administration, the particular manufacturer has no 2018 (83 FR 133), we published a notice
HHS. unresolved enforcement actions soliciting public comment of the
ACTION: Notice. pending before, or taken by, FDA. information collection. Two comments
Interested persons may request a were received in support of the
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY: The Food and Drug certificate from CFSAN electronically information collection. One comment
Administration (FDA, Agency, or we) is via the Certificate Application Process included technical suggestions as well
announcing that a proposed collection (CAP), a component of FDA Industry regarding respondents’ ability to review
of information has been submitted to the Systems, or by contacting CFSAN for and edit data that might have been
Office of Management and Budget assistance. To facilitate the application entered improperly. We appreciate this
(OMB) for review and clearance under process we have eliminated paper-based comment and continue to seek ways to
the Paperwork Reduction Act of 1995. forms. For food products, we have utilize improved information collection
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![Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Notices 22985
technologies as our resources permit. a fee of up to $175 if the Agency issues product type, but it will not exceed
FDA notes section 801 of the Federal a certificate within 20 days of receipt of $175.
Food, Drug, and Cosmetic Act (21 U.S.C. a complete request for such a certificate. We estimate the burden of the
381) also provides that FDA may charge This fee may vary depending on the information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average burden per
Number of Total annual
Type of respondent FDA Form No.2 responses per response Total hours
respondents responses
respondent (in hours)
Cosmetics ..................... 3613d .......................... 270 3 810 0.5 (30 minutes) .......... 405
Food ............................. 3613e, 3613g, 3613l ... 881 5 4,405 0.5 (30 minutes) .......... 2,203
Total ...................... ..................................... ........................ ........................ ........................ ..................................... 2,608
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 All forms are submitted electronically via CAP.
This estimate reflects a revision DEPARTMENT OF HEALTH AND Type of Collection: New.
resulting from the elimination of paper- HUMAN SERVICES Abstract: The Office of the Assistant
based forms. Specifically, and based on Secretary for Planning and Evaluation
[Document Identifier: OS–0990–new] (ASPE) at the U.S. Department of Health
our experience with the information
collection, we have reduced the and Human Services (HHS) is
Agency Information Collection
estimated time to prepare a submission requesting Office of Management and
Request. 30-Day Public Comment
from 1.5 hours to 0.5 hour. The previous Budget (OMB) approval for data
Request
estimate was based on the time collection activities to support the
AGENCY: Office of the Secretary, HHS. evaluation of the Substance Abuse and
necessary to prepare a paper
ACTION: Notice. Mental Health Services
submission, but all firms requesting
Administration’s (SAMHSA’s) Assisted
export certificates now provide SUMMARY: In compliance with the Outpatient Treatment (AOT) Grant
submissions electronically via CAP. We requirement of the Paperwork Program for Individuals with Serious
believe that the time to prepare an Reduction Act of 1995, the Office of the Mental Illness (SM–16–011). Enacted
electronic submission is under 0.25 Secretary (OS), Department of Health into law on April 1, 2014, Section 224
hour, but are estimating 0.5 hour as a and Human Services, is publishing the of the Protecting Access to Medicare Act
conservative approach to address all following summary of a proposed (PAMA) (Pub. L. 113–93) mandated a 4-
scenarios. We base our estimates of the collection for public comment. year pilot program of grants to
total annual responses on our DATES: Comments on the ICR must be implement AOT programs nationwide.
experience with certificate applications received on or before June 18, 2018. Section 224(e) required a program
received in the past 3 fiscal years. ADDRESSES: Submit your comments to evaluation to examine the impact of
We expect that most firms requesting OIRA_submission@omb.eop.gov or via AOT on cost savings and public health
export certificates in the next 3 years facsimile to (202) 395–5806. outcomes, incarceration, homelessness,
and patient and family satisfaction with
will choose to take advantage of the FOR FURTHER INFORMATION CONTACT:
program participation.
option of electronic submission via Sherrette Funn, Sherrette.Funn@hhs.gov Focusing specifically on six of the 17
CAP. If a firm is unable to submit their or (202) 795–7714. When submitting sites, the in-depth implementation and
information via CAP, they may contact comments or requesting information, outcome evaluation of the SAMHSA
CFSAN and request assistance. CFSAN please include the document identifier AOT Grant Program for Individuals with
will assist firms in entering their 0990–New–30D and project title for Serious Mental Illness is being carried
information into the electronic system reference. out by RTI International, in partnership
so that the firm may receive their export SUPPLEMENTARY INFORMATION: Interested with Duke University and Policy
certificates in a timely manner. Our persons are invited to send comments Research Associates. The completed
burden estimates in table 1 are based on regarding this burden estimate or any implementation evaluation, conducted
the expectation of 100 percent other aspect of this collection of from November 2016 to August 2017,
participation in the electronic information, including any of the gathered information related to the
submission process. Providing the following subjects: (1) The necessity and processes and practices of AOT across
opportunity to submit the information utility of the proposed information the six in-depth sites. The information
in electronic format has reduced our collection for the proper performance of to be collected for the outcome
previous estimates for the time to the agency’s functions; (2) the accuracy evaluation will allow ASPE and
prepare each submission. of the estimated burden; (3) ways to partners SAMHSA and NIMH to assess
enhance the quality, utility, and clarity which elements of AOT programs
Dated: May 14, 2018. of the information to be collected; and influence health and social outcomes for
Leslie Kux, (4) the use of automated collection people under AOT orders, as well as the
daltland on DSKBBV9HB2PROD with NOTICES
Associate Commissioner for Policy. techniques or other forms of information use of services, associated costs, and
[FR Doc. 2018–10551 Filed 5–16–18; 8:45 am] technology to minimize the information patient and family satisfaction with the
BILLING CODE 4164–01–P collection burden. AOT process.
Title of the Collection: Evaluation of Need and Proposed Use of the
the Assisted Outpatient Treatment Grant Information: Section 224(e) of PAMA
Program for Individuals with Serious requires annual reports to Congress that
Mental Illness. include evaluation of: Cost savings and
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Document Created: 2018-05-17 00:51:18
Document Modified: 2018-05-17 00:51:18
| 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 18, 2018. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 83 FR 22984 |
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