82 FR 28858 - Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 121 (June 26, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 121 (June 26, 2017)
| Page Range | 28858-28860 | |
| FR Document | 2017-13296 |
[Federal Register Volume 82, Number 121 (Monday, June 26, 2017)] [Notices] [Pages 28858-28860] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-13296] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0312] Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals 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 reporting requirements associated with extralabel drug use in animals. DATES: Submit either electronic or written comments on the collection of information by August 25, 2017. 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 25, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 25, 2017. 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 [[Page 28859]] 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-2008-N-0312 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals.'' 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: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [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. Extralabel Drug Use in Animals--21 CFR Part 530 OMB Control Number 0910-0325--Extension The Animal Medicinal Drug Use Clarification Act of 1994 allows a veterinarian to prescribe the extralabel use of approved new animal drugs. Also, it permits FDA, if it finds that there is a reasonable probability that the extralabel use of an animal drug may present a risk to the public health, to establish a safe level for a residue from the extralabel use of the drug, and to require the development of an analytical method for the detection of residues above that established safe level (21 CFR 530.22(b)). Although to date, we have not established a safe level for a residue from the extralabel use of any new animal drug and, therefore, have not required the development of analytical methodology, we believe that there may be instances when analytical methodology will be required. We are, therefore, estimating the reporting burden based on two methods being required annually. The requirement to establish an analytical method may be fulfilled by any interested person. We believe that the sponsor of the drug will be willing to develop the method in most cases. Alternatively, FDA, the sponsor, and perhaps a third party may cooperatively arrange for method development. The respondents may be sponsors of new animal drugs, State, or Federal and/or State Agencies, academia, or individuals. FDA estimates the burden of this collection of information as follows: [[Page 28860]] Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- 530.22(b), Submission(s) of 2 1 2 4,160 8,320 Analytical Method.............. ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The burden for this information collection has not changed since the last OMB approval. Dated: June 20, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-13296 Filed 6-23-17; 8:45 am] BILLING CODE 4164-01-P
![28858 Federal Register / Vol. 82, No. 121 / Monday, June 26, 2017 / Notices
to ensure that defective devices are reporting and recordkeeping burden is respondents who submit corrections
removed from the market. This will based on Agency records and our and removals using the electronic
assure that FDA has current and experience with this program, as well as process will be establishing a new
complete information regarding these similar programs that utilize FDA’s ESG. WebTrader account and purchasing a
corrections and removals to determine For respondents who submit digital verification certificate. We
whether recall action is adequate. corrections and removals using the therefore estimate the total operating
Failure to collect this information electronic process, the operating and and maintenance costs to be $30,660
would prevent FDA from receiving maintenance costs associated with this annually (1,022 respondents × $30).
timely information about devices that information collection are
approximately $30 per year to purchase In the Federal Register of March 20,
may have a serious effect on the health
a digital verification certificate 2017 (82 FR 14367), FDA published a
of users of the devices.
Reports of corrections and removals (certificate must be valid for 1 to 3 60-day notice requesting public
may be submitted to FDA via mail or years). This burden may be minimized comment on the proposed collection of
using FDA’s Electronic Submission if the respondent has already purchased information. No comments were
Gateway (ESG). We estimate that a verification certificate for other received.
approximately 99 percent of submitters electronic submissions to FDA. FDA estimates the burden of this
will use the ESG. Our estimate of the However, FDA is assuming that all collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Activity Number of Total annual Total operating and
responses per burden per Total hours 2
(21 CFR part) respondents responses maintenance costs
respondent response
Electronic process setup 3 ............. 1,022 1 1,022 3.08 3,148 $30,660
Submission of corrections and re-
movals (part 806) ....................... 1,033 1 1,033 10 10,330 ..................................
1 There are no capital costs associated with this collection of information.
2 Totals may not sum due to rounding.
3 We estimate that approximately 99 percent of respondents will submit corrections and removals using the electronic process. The actual bur-
den hours for setup of the electronic process listed in the reporting burden table are divided by 3 to avoid double counting in the Office of Infor-
mation and Regulatory Affairs Consolidated Information System. However, the one-time Average Burden per Response is 9.25 hours, resulting in
a total one-time burden of 9,454 hours for the setup of the electronic process.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Activity Number of Total annual
records per burden per Total hours
(21 CFR part) recordkeepers records
recordkeeper recordkeeping
Records of corrections and removals (part 806) ................. 93 1 93 10 930
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 20, 2017. certain information by the Agency. delivery/courier (for written/paper
Anna K. Abram, Under the Paperwork Reduction Act of submissions) will be considered timely
Deputy Commissioner for Policy, Planning, 1995 (PRA), Federal Agencies are if they are postmarked or the delivery
Legislation, and Analysis. required to publish notice in the service acceptance receipt is on or
[FR Doc. 2017–13248 Filed 6–23–17; 8:45 am] Federal Register concerning each before that date.
BILLING CODE 4164–01–P proposed collection of information, Electronic Submissions
including each proposed extension of an
existing collection of information, and Submit electronic comments in the
DEPARTMENT OF HEALTH AND to allow 60 days for public comment in following way.
HUMAN SERVICES response to the notice. This notice • Federal eRulemaking Portal: https://
solicits comments on the reporting www.regulations.gov. Follow the
Food and Drug Administration requirements associated with extralabel instructions for submitting comments.
drug use in animals. Comments submitted electronically,
[Docket No. FDA–2008–N–0312] including attachments, to https://
DATES: Submit either electronic or www.regulations.gov will be posted to
Agency Information Collection written comments on the collection of the docket unchanged. Because your
Activities; Proposed Collection; information by August 25, 2017. comment will be made public, you are
Comment Request; Extralabel Drug
ADDRESSES: You may submit comments solely responsible for ensuring that your
Use in Animals
as follows. Please note that late, comment does not include any
untimely filed comments will not be confidential information that you or a
sradovich on DSK3GMQ082PROD with NOTICES
AGENCY: Food and Drug Administration,
HHS. considered. Electronic comments must third party may not wish to be posted,
ACTION: Notice. be submitted on or before August 25, such as medical information, your or
2017. The https://www.regulations.gov anyone else’s Social Security number, or
SUMMARY: The Food and Drug electronic filing system will accept confidential business information, such
Administration (FDA or Agency) is comments until midnight Eastern Time as a manufacturing process. Please note
announcing an opportunity for public at the end of August 25, 2017. that if you include your name, contact
comment on the proposed collection of Comments received by mail/hand information, or other information that
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![28860 Federal Register / Vol. 82, No. 121 / Monday, June 26, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response
530.22(b), Submission(s) of Analytical Method ................... 2 1 2 4,160 8,320
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden for this information priority review vouchers to sponsors of (OMB) for review and clearance under
collection has not changed since the last approved rare pediatric disease product the Paperwork Reduction Act of 1995.
OMB approval. applications that meet certain criteria. DATES: Fax written comments on the
Dated: June 20, 2017. FDA has determined that Brineura collection of information by July 26,
Anna K. Abram,
(cerliponase alfa) manufactured by 2017.
Biomarin Pharmaceuticals Inc., meets ADDRESSES: To ensure that comments on
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
the criteria for a priority review the information collection are received,
voucher. Brineura (cerliponase alfa) is OMB recommends that written
[FR Doc. 2017–13296 Filed 6–23–17; 8:45 am]
indicated to slow the progression of loss comments be faxed to the Office of
BILLING CODE 4164–01–P
of ambulation in symptomatic pediatric Information and Regulatory Affairs,
patients 3 years of age and older with OMB, Attn: FDA Desk Officer, FAX:
DEPARTMENT OF HEALTH AND late infantile neuronal ceroid 202–395–7285, or emailed to oira_
HUMAN SERVICES lipofuscinosis type 2 (CLN2), also submission@omb.eop.gov. All
known as tripeptidyl peptidase 1 (TPP1) comments should be identified with the
Food and Drug Administration deficiency. OMB control number 0910–0767. Also
For further information about the Rare include the FDA docket number found
[Docket No. FDA–2017–N–0809] Pediatric Disease Priority Review in brackets in the heading of this
Voucher Program and for a link to the document.
Issuance of Priority Review Voucher;
full text of section 529 of the FD&C Act,
Rare Pediatric Disease Product FOR FURTHER INFORMATION CONTACT:
go to https://www.fda.gov/ForIndustry/
AGENCY: Food and Drug Administration, DevelopingProductsf Amber Sanford, Office of Operations,
HHS. orRareDiseasesConditions/ Food and Drug Administration, Three
RarePediatricDisease White Flint North, 10A63, 11601
ACTION: Notice.
PriorityVoucherProgram/default.htm. Landsdown St., North Bethesda, MD
SUMMARY: The Food and Drug For further information about Brineura 20852, 301–796–8867, PRAStaff@
Administration (FDA) is announcing the (cerliponase alfa) go to the ‘‘Drugs@ fda.hhs.gov.
issuance of a priority review voucher to FDA’’ Web site at https:// SUPPLEMENTARY INFORMATION: In
the sponsor of a rare pediatric disease www.accessdata.fda.gov/scripts/cder/ compliance with 44 U.S.C. 3507, FDA
product application. The Federal Food, daf/. has submitted the following proposed
Drug, and Cosmetic Act (the FD&C Act), Dated: June 20, 2017. collection of information to OMB for
as amended by the Food and Drug review and clearance.
Anna K. Abram,
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award Deputy Commissioner for Policy, Planning, Annual Reporting for Custom Device
Legislation, and Analysis. Exemption OMB Control Number 0910–
priority review vouchers to sponsors of
approved rare pediatric disease product [FR Doc. 2017–13236 Filed 6–23–17; 8:45 am] 0767—Extension
applications that meet certain criteria. BILLING CODE 4164–01–P The custom device exemption is set
FDA is required to publish notice of the forth at section 520(b)(2)(B) of the
award of the priority review voucher. Federal Food, Drug, and Cosmetic Act
DEPARTMENT OF HEALTH AND (the FD&C Act) (21 U.S.C. 360j(b)(2)(B)).
FDA has determined that Brineura
HUMAN SERVICES A custom device is in a narrow category
(cerliponase alfa) manufactured by
Biomarin Pharmaceuticals Inc., meets Food and Drug Administration of device that, by virtue of the rarity of
the criteria for a priority review the patient’s medical condition or
voucher. physician’s special need the device is
[Docket No. FDA–2017–N–1066]
designed to treat, it would be
FOR FURTHER INFORMATION CONTACT:
Agency Information Collection impractical for the device to comply
Althea Cuff, Center for Drug Evaluation
Activities; Submission for Office of with premarket review regulations and
and Research, Food and Drug
Management and Budget Review; performance standards.
Administration, 10903 New Hampshire
Comment Request; Annual Reporting The Food and Drug Administration
Ave., Bldg. 22, Rm. 6484, Silver Spring,
for Custom Device Exemption Safety and Innovation Act (FDASIA)
MD 20993–0002, 301–796–4061, FAX:
implemented changes to the custom
301–796–9858, email: althea.cuff@
AGENCY: Food and Drug Administration, device exemption contained in section
fda.hhs.gov.
sradovich on DSK3GMQ082PROD with NOTICES
HHS. 520(b) of the FD&C Act. The new
SUPPLEMENTARY INFORMATION: FDA is ACTION: Notice. provision amended the existing custom
announcing the issuance of a priority device exemption and introduced new
review voucher to the sponsor of an SUMMARY: The Food and Drug concepts and procedures for custom
approved rare pediatric disease product Administration (FDA) is announcing devices, such as:
application. Under section 529 of the that a proposed collection of • Devices created or modified in
FD&C Act (21 U.S.C. 360ff), which was information has been submitted to the order to comply with the order of an
added by FDASIA, FDA will award Office of Management and Budget individual physician or dentist;
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Document Created: 2018-11-14 10:11:38
Document Modified: 2018-11-14 10:11:38
| 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 25, 2017. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 82 FR 28858 |
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