83 FR 26699 - Agency Information Collection Activities; Proposed Collection; Comment Request; Interstate Shellfish Dealer's Certificate
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 111 (June 8, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 111 (June 8, 2018)
| Page Range | 26699-26700 | |
| FR Document | 2018-12340 |
[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)] [Notices] [Pages 26699-26700] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12340] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0232] Agency Information Collection Activities; Proposed Collection; Comment Request; Interstate Shellfish Dealer's Certificate AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the Interstate Shellfish Dealer's Certificate. DATES: Submit either electronic or written comments on the collection of information by August 7, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 7, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 7, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2009-N-0232 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Interstate Shellfish Dealer's Certificate.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and 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 [[Page 26700]] more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [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. Interstate Shellfish Dealer's Certificate OMB Control Number 0910-0021--Extension Under Section 243 of the Public Health Service Act (42 U.S.C. 243), FDA is required to cooperate with and aid State and local authorities in the enforcement of their health regulations and are authorized to assist States in the prevention and suppression of communicable diseases. Under this authority, FDA participates with State regulatory agencies, some foreign nations, and the molluscan shellfish industry in the National Shellfish Sanitation Program (NSSP). NSSP is a voluntary, cooperative program to promote the safety of molluscan shellfish by providing for the classification and patrol of shellfish growing waters and for the inspection and certification of shellfish processors. Each participating State and foreign nation monitors its molluscan shellfish processors and issues certificates for those that meet the State or foreign shellfish control authority's criteria. Each participating State and nation provides a certificate of its certified shellfish processors to FDA on Form FDA 3038, ``Interstate Shellfish Dealer's Certificate.'' FDA uses this information to publish the ``Interstate Certified Shellfish Shippers List,'' a monthly comprehensive listing of all molluscan shellfish processors certified under the cooperative program. If FDA did not collect the information necessary to compile this list, participating States would not be able to identify and keep out shellfish processed by uncertified processors in other States and foreign nations. Consequently, NSSP would not be able to control the distribution of uncertified and possibly unsafe shellfish in interstate commerce, and its effectiveness would be nullified. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity FDA Form No. Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Submission of Interstate Shellfish 3038 40 57 2,280 0.10 (6 minutes).................... 228 Dealer's Certificate. -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. We estimate that 40 respondents will submit 2,280 Interstate Shellfish Dealer's Certificates annually, for a total burden of 228 hours (2,280 submissions x 0.10 hours = 228 hours). This estimate is based on our experience with this information collection and the number of certificates received in the past 3 years, which has remained constant. Dated: June 4, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-12340 Filed 6-7-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 26699
to respond to, a collection of information unless it displays a
currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
Date
OMB
Title of collection approval
control No. expires
Biological Products—General Records and Postmarket Adverse Experience Reporting ...................................... 0910–0308 4/30/2021
Guidance for Industry: Fast Track, Drug Development Programs—Designation, Development, and Application
Review .................................................................................................................................................................. 0910–0389 4/30/2021
Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802 ..................................... 0910–0498 4/30/2021
Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy
and Lactation Labeling ......................................................................................................................................... 0910–0624 4/30/2021
Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics .................................... 0910–0629 4/30/2021
Guidance of Industry: Expedited Programs for Serious Conditions—Drugs and Biologics ................................... 0910–0765 4/30/2021
Evaluation of the Food and Drug Administration’s Point-of-Sale Campaign .......................................................... 0910–0851 4/30/2021
Dated: June 4, 2018. at the end of August 7, 2018. Comments Staff, FDA will post your comment, as
Leslie Kux, received by mail/hand delivery/courier well as any attachments, except for
Associate Commissioner for Policy. (for written/paper submissions) will be information submitted, marked and
[FR Doc. 2018–12338 Filed 6–7–18; 8:45 am] considered timely if they are identified, as confidential, if submitted
BILLING CODE 4164–01–P postmarked or the delivery service as detailed in ‘‘Instructions.’’
acceptance receipt is on or before that Instructions: All submissions received
date. must include the Docket No. FDA–
DEPARTMENT OF HEALTH AND 2009–N–0232 for ‘‘Agency Information
Electronic Submissions Collection Activities; Proposed
HUMAN SERVICES
Submit electronic comments in the Collection; Comment Request; Interstate
Food and Drug Administration following way: Shellfish Dealer’s Certificate.’’ Received
• Federal eRulemaking Portal: comments, those filed in a timely
[Docket No. FDA–2009–N–0232]
https://www.regulations.gov. Follow the manner (see ADDRESSES), will be placed
Agency Information Collection instructions for submitting comments. in the docket and, except for those
Activities; Proposed Collection; Comments submitted electronically, submitted as ‘‘Confidential
Comment Request; Interstate Shellfish including attachments, to https:// Submissions,’’ publicly viewable at
Dealer’s Certificate www.regulations.gov will be posted to https://www.regulations.gov or at the
the docket unchanged. Because your Dockets Management Staff between 9
AGENCY: Food and Drug Administration, comment will be made public, you are a.m. and 4 p.m., Monday through
HHS. solely responsible for ensuring that your Friday.
ACTION: Notice. comment does not include any • Confidential Submissions—To
confidential information that you or a submit a comment with confidential
SUMMARY: The Food and Drug third party may not wish to be posted, information that you do not wish to be
Administration (FDA or Agency) is such as medical information, your or made publicly available, submit your
announcing an opportunity for public anyone else’s Social Security number, or comments only as a written/paper
comment on the proposed collection of confidential business information, such submission. You should submit two
certain information by the Agency. as a manufacturing process. Please note copies total. One copy will include the
Under the Paperwork Reduction Act of that if you include your name, contact information you claim to be confidential
1995 (PRA), Federal Agencies are information, or other information that with a heading or cover note that states
required to publish notice in the identifies you in the body of your ‘‘THIS DOCUMENT CONTAINS
Federal Register concerning each comments, that information will be CONFIDENTIAL INFORMATION.’’ The
proposed collection of information, posted on https://www.regulations.gov. Agency will review this copy, including
including each proposed extension of an • If you want to submit a comment the claimed confidential information, in
existing collection of information, and with confidential information that you its consideration of comments. The
to allow 60 days for public comment in do not wish to be made available to the second copy, which will have the
response to the notice. This notice public, submit the comment as a claimed confidential information
solicits comments on the information written/paper submission and in the redacted/blacked out, will be available
collection provisions of the Interstate manner detailed (see ‘‘Written/Paper for public viewing and posted on
Shellfish Dealer’s Certificate. Submissions’’ and ‘‘Instructions’’). https://www.regulations.gov. Submit
DATES: Submit either electronic or both copies to the Dockets Management
written comments on the collection of Written/Paper Submissions Staff. If you do not wish your name and
information by August 7, 2018. Submit written/paper submissions as contact information to be made publicly
ADDRESSES: You may submit comments follows: available, you can provide this
amozie on DSK3GDR082PROD with NOTICES1
as follows. Please note that late, • Mail/Hand delivery/Courier (for information on the cover sheet and not
untimely filed comments will not be written/paper submissions): Dockets in the body of your comments and you
considered. Electronic comments must Management Staff (HFA–305), Food and must identify this information as
be submitted on or before August 7, Drug Administration, 5630 Fishers ‘‘confidential.’’ Any information marked
2018. The https://www.regulations.gov Lane, Rm. 1061, Rockville, MD 20852. as ‘‘confidential’’ will not be disclosed
electronic filing system will accept • For written/paper comments except in accordance with 21 CFR 10.20
comments until midnight Eastern Time submitted to the Dockets Management and other applicable disclosure law. For
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![26700 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices
more information about FDA’s posting the Federal Register concerning each communicable diseases. Under this
of comments to public dockets, see 80 proposed collection of information, authority, FDA participates with State
FR 56469, September 18, 2015, or access including each proposed extension of an regulatory agencies, some foreign
the information at: https://www.gpo.gov/ existing collection of information, nations, and the molluscan shellfish
fdsys/pkg/FR-2015-09-18/pdf/2015- before submitting the collection to OMB industry in the National Shellfish
23389.pdf. for approval. To comply with this Sanitation Program (NSSP).
Docket: For access to the docket to requirement, FDA is publishing notice NSSP is a voluntary, cooperative
read background documents or the of the proposed collection of program to promote the safety of
electronic and written/paper comments information set forth in this document.
molluscan shellfish by providing for the
received, go to https:// With respect to the following
collection of information, FDA invites classification and patrol of shellfish
www.regulations.gov and insert the growing waters and for the inspection
docket number, found in brackets in the comments on these topics: (1) Whether
the proposed collection of information and certification of shellfish processors.
heading of this document, into the Each participating State and foreign
‘‘Search’’ box and follow the prompts is necessary for the proper performance
of FDA’s functions, including whether nation monitors its molluscan shellfish
and/or go to the Dockets Management processors and issues certificates for
Staff, 5630 Fishers Lane, Rm. 1061, the information will have practical
utility; (2) the accuracy of FDA’s those that meet the State or foreign
Rockville, MD 20852. shellfish control authority’s criteria.
estimate of the burden of the proposed
FOR FURTHER INFORMATION CONTACT: Ila collection of information, including the Each participating State and nation
S. Mizrachi, Office of Operations, Food validity of the methodology and provides a certificate of its certified
and Drug Administration, Three White assumptions used; (3) ways to enhance shellfish processors to FDA on Form
Flint North, 10A–12M, 11601 the quality, utility, and clarity of the FDA 3038, ‘‘Interstate Shellfish Dealer’s
Landsdown St., North Bethesda, MD information to be collected; and (4) Certificate.’’ FDA uses this information
20852, 301–796–7726, PRAStaff@ ways to minimize the burden of the to publish the ‘‘Interstate Certified
fda.hhs.gov. collection of information on Shellfish Shippers List,’’ a monthly
SUPPLEMENTARY INFORMATION: Under the respondents, including through the use comprehensive listing of all molluscan
PRA (44 U.S.C. 3501–3520), Federal of automated collection techniques, shellfish processors certified under the
Agencies must obtain approval from the when appropriate, and other forms of cooperative program. If FDA did not
Office of Management and Budget information technology. collect the information necessary to
(OMB) for each collection of compile this list, participating States
Interstate Shellfish Dealer’s Certificate
information they conduct or sponsor. would not be able to identify and keep
‘‘Collection of information’’ is defined OMB Control Number 0910–0021— out shellfish processed by uncertified
in 44 U.S.C. 3502(3) and 5 CFR Extension processors in other States and foreign
1320.3(c) and includes Agency requests Under Section 243 of the Public nations. Consequently, NSSP would not
or requirements that members of the Health Service Act (42 U.S.C. 243), FDA be able to control the distribution of
public submit reports, keep records, or is required to cooperate with and aid uncertified and possibly unsafe shellfish
provide information to a third party. State and local authorities in the in interstate commerce, and its
Section 3506(c)(2)(A) of the PRA (44 enforcement of their health regulations effectiveness would be nullified.
U.S.C. 3506(c)(2)(A)) requires Federal and are authorized to assist States in the FDA estimates the burden of this
Agencies to provide a 60-day notice in prevention and suppression of collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total
Number of Average burden
Activity FDA Form No. responses per annual Total hours
respondents per response
respondent responses
Submission of Interstate Shell- 3038 40 57 2,280 0.10 (6 minutes) ............. 228
fish Dealer’s Certificate.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information Dated: June 4, 2018. amended, notice is hereby given of the
collection since our last request for Leslie Kux, following meeting.
OMB approval, we have made no Associate Commissioner for Policy. The meeting will be closed to the
adjustments to our burden estimate. We [FR Doc. 2018–12340 Filed 6–7–18; 8:45 am] public in accordance with the
estimate that 40 respondents will BILLING CODE 4164–01–P
provisions set forth in sections
submit 2,280 Interstate Shellfish 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Dealer’s Certificates annually, for a total as amended. The grant applications and
burden of 228 hours (2,280 submissions DEPARTMENT OF HEALTH AND the discussions could disclose
× 0.10 hours = 228 hours). This estimate HUMAN SERVICES confidential trade secrets or commercial
is based on our experience with this property such as patentable material,
amozie on DSK3GDR082PROD with NOTICES1
National Institutes of Health and personal information concerning
information collection and the number
individuals associated with the grant
of certificates received in the past 3 National Center for Advancing applications, the disclosure of which
years, which has remained constant. Translational Sciences; Notice of would constitute a clearly unwarranted
Closed Meeting invasion of personal privacy.
Pursuant to section 10(d) of the Name of Committee: National Center for
Federal Advisory Committee Act, as Advancing Translational Sciences Special
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Document Created: 2018-06-08 01:22:06
Document Modified: 2018-06-08 01:22:06
| 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 August 7, 2018. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 83 FR 26699 |
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