83 FR 5438 - Agency Information Collection Activities; Proposed Collection; Comment Request; State Enforcement Notifications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 26 (February 7, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 26 (February 7, 2018)
| Page Range | 5438-5439 | |
| FR Document | 2018-02417 |
[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)] [Notices] [Pages 5438-5439] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02417] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0074] Agency Information Collection Activities; Proposed Collection; Comment Request; State Enforcement Notifications 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 reporting requirements contained in existing FDA regulations governing State enforcement notifications. DATES: Submit either electronic or written comments on the collection of information by April 9, 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 April 9, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 9, 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-2018-N-0074 for ``State Enforcement [[Page 5439]] Notifications.'' 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 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: 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: 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. State Enforcement Notifications--21 CFR 100.2(d) OMB Control Number 0910-0275--Extension This information collection supports Agency regulations. Specifically, section 310(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 337(b)) authorizes a State to enforce certain sections of the FD&C Act in their own name and within their own jurisdiction. However, before doing so, a State must provide notice to FDA according to 21 CFR 100.2. The information required in a letter of notification under Sec. 100.2(d) enables us to identify the food against which a State intends to take action and to advise that State whether Federal enforcement action against the food has been taken or is in process. With certain narrow exceptions, Federal enforcement action precludes State action under the FD&C Act. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of responses per Total annual Average burden Total respondents respondents responses per response hours ----------------------------------------------------------------------------------------------------------- ------- 100.2(d)............................... 1 1 1 10 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The estimated burden for this information collection has not changed since the last OMB approval. The estimated reporting burden for Sec. 100.2(d) is minimal because enforcement notifications are seldom used by States. During the last 3 years, we have not received any new enforcement notifications; therefore, we estimate that one or fewer notifications will be submitted annually. Although we have not received any new enforcement notifications in the last 3 years, we believe these information collection provisions should be extended to provide for the potential future need of a State government to submit enforcement notifications informing us when it intends to take enforcement action under the FD&C Act against a particular food located in the State. Dated: January 31, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-02417 Filed 2-6-18; 8:45 am] BILLING CODE 4164-01-P
![5438 Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Notices
improve glycemic control in adults with for a redetermination (see DATES). DATES: Submit either electronic or
type 2 diabetes mellitus. Subsequent to Furthermore, as specified in § 60.30 (21 written comments on the collection of
this approval, the USPTO received CFR 60.30), any interested person may information by April 9, 2018.
patent term restoration applications for petition FDA for a determination ADDRESSES: You may submit comments
FARXIGA (U.S. Patent Nos. 6,414,126 regarding whether the applicant for as follows: Please note that late,
and 6,515,117) from AstraZeneca AB, extension acted with due diligence untimely filed comments will not be
and the USPTO requested FDA’s during the regulatory review period. To considered. Electronic comments must
assistance in determining the patents’ meet its burden, the petition must be submitted on or before April 9, 2018.
eligibility for patent term restoration. In comply with all the requirements of The https://www.regulations.gov
a letter dated October 19, 2015, FDA § 60.30, including but not limited to: electronic filing system will accept
advised the USPTO that this human Must be timely (see DATES), must be comments until midnight Eastern Time
drug product had undergone a filed in accordance with § 10.20, must at the end of April 9, 2018. Comments
regulatory review period and that the contain sufficient facts to merit an FDA received by mail/hand delivery/courier
approval of FARXIGA represented the investigation, and must certify that a (for written/paper submissions) will be
first permitted commercial marketing or true and complete copy of the petition considered timely if they are
use of the product. Thereafter, the has been served upon the patent postmarked or the delivery service
USPTO requested that FDA determine applicant. (See H. Rept. 857, part 1, 98th acceptance receipt is on or before that
the product’s regulatory review period. Cong., 2d sess., pp. 41–42, 1984.) date.
II. Determination of Regulatory Review Petitions should be in the format
Electronic Submissions
Period specified in 21 CFR 10.30.
Submit petitions electronically to Submit electronic comments in the
FDA has determined that the https://www.regulations.gov at Docket following way:
applicable regulatory review period for No. FDA–2013–S–0610. Submit written • Federal eRulemaking Portal:
FARXIGA is 3,673 days. Of this time, petitions (two copies are required) to the https://www.regulations.gov. Follow the
2,565 days occurred during the testing Dockets Management Staff (HFA–305), instructions for submitting comments.
phase of the regulatory review period, Food and Drug Administration, 5630 Comments submitted electronically,
while 1,108 days occurred during the Fishers Lane, Rm. 1061, Rockville, MD including attachments, to https://
approval phase. These periods of time 20852. www.regulations.gov will be posted to
were derived from the following dates: the docket unchanged. Because your
1. The date an exemption under Dated: January 31, 2018.
comment will be made public, you are
section 505(i) of the Federal Food, Drug, Leslie Kux, solely responsible for ensuring that your
and Cosmetic Act (the FD&C Act) (21 Associate Commissioner for Policy. comment does not include any
U.S.C. 355(i)) became effective: [FR Doc. 2018–02418 Filed 2–6–18; 8:45 am] confidential information that you or a
December 21, 2003. FDA has verified BILLING CODE 4164–01–P third party may not wish to be posted,
the AstraZeneca AB claim that the date such as medical information, your or
the investigational new drug application anyone else’s Social Security number, or
became effective was on December 21, DEPARTMENT OF HEALTH AND confidential business information, such
2003. HUMAN SERVICES as a manufacturing process. Please note
2. The date the application was that if you include your name, contact
initially submitted with respect to the Food and Drug Administration information, or other information that
human drug product under section [Docket No. FDA–2018–N–0074] identifies you in the body of your
505(b) of the FD&C Act: December 28, comments, that information will be
2010. The applicant claims December Agency Information Collection posted on https://www.regulations.gov.
27, 2010, as the date the new drug Activities; Proposed Collection; • If you want to submit a comment
application (NDA) for FARXIGA (NDA Comment Request; State Enforcement with confidential information that you
202293) was initially submitted. Notifications do not wish to be made available to the
However, FDA records indicate that public, submit the comment as a
NDA 202293 was submitted on AGENCY: Food and Drug Administration, written/paper submission and in the
December 28, 2010. HHS. manner detailed (see ‘‘Written/Paper
3. The date the application was ACTION: Notice. Submissions’’ and ‘‘Instructions’’).
approved: January 8, 2014. FDA has
verified the applicant’s claim that NDA SUMMARY: The Food and Drug Written/Paper Submissions
202293 was approved on January 8, Administration (FDA or Agency) is Submit written/paper submissions as
2014. announcing an opportunity for public follows:
This determination of the regulatory comment on the proposed collection of • Mail/Hand delivery/Courier (for
review period establishes the maximum certain information by the Agency. written/paper submissions): Dockets
potential length of a patent extension. Under the Paperwork Reduction Act of Management Staff (HFA–305), Food and
However, the USPTO applies several 1995 (PRA), Federal Agencies are Drug Administration, 5630 Fishers
statutory limitations in its calculations required to publish notice in the Lane, Rm. 1061, Rockville, MD 20852.
of the actual period for patent extension. Federal Register concerning each • For written/paper comments
In its applications for patent extension, proposed collection of information, submitted to the Dockets Management
including each proposed extension of an
sradovich on DSK3GMQ082PROD with NOTICES
this applicant seeks 1,825 days of patent Staff, FDA will post your comment, as
term extension. existing collection of information, and well as any attachments, except for
to allow 60 days for public comment in information submitted, marked and
III. Petitions response to the notice. This notice identified, as confidential, if submitted
Anyone with knowledge that any of solicits comments on reporting as detailed in ‘‘Instructions.’’
the dates as published are incorrect may requirements contained in existing FDA Instructions: All submissions received
submit either electronic or written regulations governing State enforcement must include the Docket No. FDA–
comments and, under 21 CFR 60.24, ask notifications. 2018–N–0074 for ‘‘State Enforcement
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![Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Notices 5439
Notifications.’’ Received comments, Docket: For access to the docket to the proposed collection of information
those filed in a timely manner (see read background documents or the is necessary for the proper performance
ADDRESSES), will be placed in the docket electronic and written/paper comments of FDA’s functions, including whether
and, except for those submitted as received, go to https:// the information will have practical
‘‘Confidential Submissions,’’ publicly www.regulations.gov and insert the utility; (2) the accuracy of FDA’s
viewable at https://www.regulations.gov docket number, found in brackets in the estimate of the burden of the proposed
or at the Dockets Management Staff heading of this document, into the collection of information, including the
between 9 a.m. and 4 p.m., Monday ‘‘Search’’ box and follow the prompts validity of the methodology and
through Friday. and/or go to the Dockets Management assumptions used; (3) ways to enhance
• Confidential Submissions—To Staff, 5630 Fishers Lane, Rm. 1061, the quality, utility, and clarity of the
submit a comment with confidential Rockville, MD 20852. information to be collected; and (4)
information that you do not wish to be FOR FURTHER INFORMATION CONTACT: ways to minimize the burden of the
made publicly available, submit your Domini Bean, Office of Operations, collection of information on
comments only as a written/paper Food and Drug Administration, Three respondents, including through the use
submission. You should submit two White Flint North, 10A–12M, 11601 of automated collection techniques,
copies total. One copy will include the Landsdown St., North Bethesda, MD when appropriate, and other forms of
information you claim to be confidential 20852, 301–796–5733, PRAStaff@ information technology.
with a heading or cover note that states fda.hhs.gov.
State Enforcement Notifications—21
‘‘THIS DOCUMENT CONTAINS SUPPLEMENTARY INFORMATION: Under the CFR 100.2(d)
CONFIDENTIAL INFORMATION.’’ The PRA (44 U.S.C. 3501–3520), Federal
Agency will review this copy, including Agencies must obtain approval from the OMB Control Number 0910–0275—
the claimed confidential information, in Office of Management and Budget Extension
its consideration of comments. The (OMB) for each collection of
second copy, which will have the This information collection supports
information they conduct or sponsor.
claimed confidential information Agency regulations. Specifically, section
‘‘Collection of information’’ is defined
redacted/blacked out, will be available 310(b) of the Federal Food, Drug, and
in 44 U.S.C. 3502(3) and 5 CFR
for public viewing and posted on Cosmetic Act (FD&C Act) (21 U.S.C.
1320.3(c) and includes Agency requests
https://www.regulations.gov. Submit 337(b)) authorizes a State to enforce
or requirements that members of the
both copies to the Dockets Management certain sections of the FD&C Act in their
public submit reports, keep records, or
Staff. If you do not wish your name and own name and within their own
provide information to a third party.
contact information to be made publicly jurisdiction. However, before doing so,
Section 3506(c)(2)(A) of the PRA (44
available, you can provide this a State must provide notice to FDA
U.S.C. 3506(c)(2)(A)) requires Federal
information on the cover sheet and not according to 21 CFR 100.2. The
Agencies to provide a 60-day notice in
in the body of your comments and you information required in a letter of
the Federal Register concerning each
must identify this information as notification under § 100.2(d) enables us
proposed collection of information,
‘‘confidential.’’ Any information marked including each proposed extension of an to identify the food against which a
as ‘‘confidential’’ will not be disclosed existing collection of information, State intends to take action and to
except in accordance with 21 CFR 10.20 before submitting the collection to OMB advise that State whether Federal
and other applicable disclosure law. For for approval. To comply with this enforcement action against the food has
more information about FDA’s posting requirement, FDA is publishing notice been taken or is in process. With certain
of comments to public dockets, see 80 of the proposed collection of narrow exceptions, Federal enforcement
FR 56469, September 18, 2015, or access information set forth in this document. action precludes State action under the
the information at: https://www.gpo.gov/ With respect to the following FD&C Act.
fdsys/pkg/FR-2015-09-18/pdf/2015- collection of information, FDA invites FDA estimates the burden of this
23389.pdf. comments on these topics: (1) Whether collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section responses per burden per
respondents responses
respondents response
100.2(d) ............................................................................................................ 1 1 1 10
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated burden for this will be submitted annually. Although against a particular food located in the
information collection has not changed we have not received any new State.
since the last OMB approval. enforcement notifications in the last 3 Dated: January 31, 2018.
The estimated reporting burden for years, we believe these information
Leslie Kux,
sradovich on DSK3GMQ082PROD with NOTICES
§ 100.2(d) is minimal because collection provisions should be
enforcement notifications are seldom extended to provide for the potential Associate Commissioner for Policy.
used by States. During the last 3 years, future need of a State government to [FR Doc. 2018–02417 Filed 2–6–18; 8:45 am]
we have not received any new submit enforcement notifications BILLING CODE 4164–01–P
enforcement notifications; therefore, we informing us when it intends to take
estimate that one or fewer notifications enforcement action under the FD&C Act
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Document Created: 2018-10-26 13:57:27
Document Modified: 2018-10-26 13:57:27
| 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 April 9, 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 5438 |
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