82 FR 51279 - Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 212 (November 3, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 212 (November 3, 2017)
| Page Range | 51279-51282 | |
| FR Document | 2017-23948 |
[Federal Register Volume 82, Number 212 (Friday, November 3, 2017)] [Notices] [Pages 51279-51282] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23948] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0510] Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed 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 [[Page 51280]] collection provisions of existing FDA regulations concerning substances prohibited for use in animal food or feed. DATES: Submit either electronic or written comments on the collection of information by January 2, 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 January 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 2, 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-2011-N-0510 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed.'' 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, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, 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. Substances Prohibited From Use in Animal Food or Feed--21 CFR 589.2001 OMB Control Number 0910-0627--Extension This information collection supports Agency regulations regarding substances prohibited from use in animal food or feed. Bovine spongiform encephalopathy (BSE) is a progressive and fatal neurological disorder of cattle that results from an unconventional transmissible agent. BSE belongs to the family of diseases known as transmissible spongiform encephalopathies (TSEs). All TSEs affect the central nervous system of infected animals. Our regulation at Sec. 589.2001 (21 CFR 589.2001) entitled, [[Page 51281]] ``Cattle materials prohibited in animal food or feed to prevent the transmission of bovine spongiform encephalopathy'' is designed to further strengthen existing safeguards against the establishment and amplification of BSE in the United States through animal feed. The regulation prohibits the use of certain cattle origin materials in the food or feed of all animals. These materials are referred to as ``cattle materials prohibited in animal feed'' or CMPAF. Under Sec. 589.2001, no animal feed or feed ingredient can contain CMPAF. As a result, we impose requirements on renderers of specifically defined cattle materials, including reporting and recordkeeping requirements. For purposes of the regulation, we define a renderer as any firm or individual that processes slaughter byproducts, animals unfit for human consumption, including carcasses of dead cattle, or meat scraps. Reporting and recordkeeping requirements are necessary because once materials are separated from an animal it may not be possible, without records, to know whether the cattle material meets the requirements of our regulation. Recordkeeping: Renderers that receive, manufacture, process, blend, or distribute CMPAF, or products that contain or may contain CMPAF, must take measures to ensure that the materials are not introduced into animal feed, including maintaining adequate written procedures specifying how such processes are to be carried out Sec. 589.2001(c)(2)(ii)). Renderers that receive, manufacture, process, blend, or distribute CMPAF, are required to establish and maintain records sufficient to track the CMPAF to ensure that they are not introduced into animal feed (Sec. 589.2001(c)(2)(vi)). Renderers that receive, manufacture, process, blend, or distribute any cattle materials must establish and maintain records sufficient to demonstrate that material rendered for use in animal feed was not manufactured from, processed with, or does not otherwise contain, CMPAF (Sec. 589.2001(c)(3)(i)). Renderers that receive, manufacture, process, blend, or distribute any cattle materials must, if these materials were obtained from an establishment that segregates CMPAF from other materials, establish and maintain records to demonstrate that the supplier has adequate procedures in place to effectively exclude CMPAF from any materials supplied (Sec. 589.2001(c)(3)(i)). Records will meet this requirement if they include either: (1) Certification or other documentation from the supplier that materials supplied do not include CMPAF (Sec. 589.2001(c)(3)(i)(A)) or (2) documentation of another method acceptable to FDA, such as third-party certification (Sec. 589.2001(c)(3)(i)(B)). Reporting: Under our regulations, we may designate a country from which cattle materials are not considered CMPAF. Section 589.2001(f) provides that a country seeking to be so designated must send a written request to the Director of the Center for Veterinary Medicine. The information the country is required to submit includes information about that country's BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other information relevant to determining whether the cattle materials from the requesting country do or do not meet the definitions set forth in Sec. 589.2001(b)(1). We use the information to determine whether to grant a request for designation and to impose conditions if a request is granted. Section 589.2001(f) further states that countries designated under that section will be subject to our future review to determine whether their designations remain appropriate. As part of this process, we may ask designated countries from time to time to confirm that their BSE situation and the information submitted by them in support of their original application remains unchanged. We may revoke a country's designation if we determine that it is no longer appropriate. Therefore, designated countries may respond to our periodic requests by submitting information to confirm their designations remain appropriate. We use the information to ensure their designations remain appropriate. Description of Respondents: Respondents to this information collection include rendering facilities, feed manufacturers, livestock feeders, and foreign governments seeking designation under Sec. 589.2001(f). FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average 21 CFR section Number of records per Total annual burden per Total hours recordkeepers recordkeeper records recordkeeping ---------------------------------------------------------------------------------------------------------------- 589.2001(c)(2)(ii), maintain 50 1 50 20 1,000 written procedures............ 589.2001(c)(2)(vi) and 175 1 175 20 3,500 (c)(3)(i), maintain records... 589.2001(c)(3)(i)(A) and (B), 175 1 175 26 4,550 certification or documentation from the supplier............. -------------------------------------------------------------------------------- Total...................... ............... .............. .............. .............. 9,050 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Except where otherwise noted, this estimate is based on our estimate of the number of facilities affected by the final rule entitled, ``Substances Prohibited From Use in Animal Food or Feed'', published in the Federal Register of April 25, 2008 (73 FR 22720 at 22753). The estimated recordkeeping burden is derived from Agency resources and discussions with affected industry. Our regulations require the maintenance of certain written procedures if cattle not inspected and passed for human consumption are to be rendered for use in animal feed. The recordkeeping burden associated with the requirement to maintain written procedures (Sec. 589.2001(c)(2)(ii)) will apply to only those renderers that choose to render for use in animal feed cattle not inspected and passed for human consumption. The recordkeeping requirement in Sec. 589.2001(c)(2)(vi) will apply to the limited number of renderers that will handle CMPAF. We estimate that the recordkeeping burden associated with Sec. 589.2001(c)(3)(i) would apply to the balance of the rendering firms not handling CMPAF. Table 1 also reflects the estimated 26 hours each renderer will need to satisfy the requirement in Sec. 589.2001(c)(3)(i)(A) and (B) under which renderers must maintain records from their supplier, certifying that materials provided were free of CMPAF. [[Page 51282]] Table 2--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average 21 CFR section Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- 589.2001(f); request for 1 1 1 80 80 designation.................... 589.2001(f); response to request 1 1 1 26 26 for review by FDA.............. ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Our estimate of the reporting burden for designation under Sec. 589.2001(f) is based on estimates in the final rule entitled, ``Substances Prohibited From Use in Animal Food or Feed,'' published in the Federal Register of April 25, 2008, our experience, and the average number of requests for designation received in the past 3 years. The reporting burden for Sec. 589.2001(f) is minimal because requests for designation are seldom submitted. Since 2009, we have received two requests for designation. In the last 3 years, we have not received any new requests for designation; therefore, we estimate that one or fewer requests for designation will be submitted annually. Although we have not received any new requests for designation in the last 3 years, we believe these information collection provisions should be extended to provide for the potential future need of a foreign government to request designation under Sec. 589.2001(f). Table 2, row 1 presents the expected burden of requests for designation. Countries designated under Sec. 589.2001(f) are subject to review by FDA to ensure that their designation remains appropriate. We assume a country's response to a request for review will take about one third the time and effort of a request for designation. Table 2, row 2 presents the expected burden of a request for review. The burden for this information collection has not changed since the last OMB approval. Dated: October 24, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-23948 Filed 11-2-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Notices 51279
We invite comments on these topics: (3) the FDA-assigned control number the clarifying questions and the
(1) Whether the proposed collection of and submission date of any previous, corresponding section(s) of FDA’s
information is necessary for the proper related controlled correspondence that controlled correspondence response on
performance of FDA’s functions, was accepted for substantial review and which the requestor is seeking
including whether the information will response, if any, as well as a copy of clarification.
have practical utility; (2) the accuracy of that previous controlled correspondence The following information is based on
FDA’s estimate of the burden of the and FDA’s response, if any; (4) the inquiries considered controlled
proposed collection of information, relevant reference listed drug(s), as correspondence and submitted to FDA
including the validity of the applicable, including the application for fiscal years 2014, 2015, and 2016.
methodology and assumptions used; (3) number, proprietary (brand) name, FDA estimates approximately 390
ways to enhance the quality, utility, and manufacturer, active ingredient, dosage generic drug manufacturers and related
clarity of the information to be form, and strength(s); (5) a statement industry (e.g., contract research
collected; and (4) ways to minimize the that the controlled correspondence is organizations conducting bioanalytical
burden of the collection of information related to a potential abbreviated new or bioequivalence clinical trials) or their
on respondents, including through the drug application (ANDA) submission to representatives would each submit an
use of automated collection techniques, the Office of Generic Drugs, and the average of 3.8 inquiries annually for a
when appropriate, and other forms of ANDA number, if applicable; (6) a total of 1,496 inquiries [1,496 ÷ 390 =
information technology. concise statement of the inquiry; (7) a 3.8]. Information submitted with each
Title: Controlled Correspondence recommendation of the appropriate FDA inquiry varies widely in content,
Related to Generic Drug Development— review discipline; and (8) relevant prior depending on the complexity of the
OMB Control Number 0910–0797— research and supporting materials. request. Inquiries that are defined as
Revision.
Description: FDA has agreed to The GDUFA II Commitment Letter controlled correspondence may range
specific program enhancements and also includes details on FDA’s from a simple inquiry on generic drug
performance goals specified in the commitment to respond to requests to labeling to a more complex inquiry for
GDUFA II Commitment Letter. One of clarify ambiguities in FDA’s controlled a formulation assessment for a specific
the performance goals applies to correspondence response within certain proposed generic drug product. As a
controlled correspondence related to time frames. To facilitate FDA’s prompt result, these inquiries can vary between
generic drug development. The GDUFA consideration of the request, and to 1 to 10 burden hours, respectively.
II Commitment Letter includes details assist in meeting the prescribed time Because the content of inquiries
on FDA’s commitment to respond to frames, FDA recommends including the considered controlled correspondence is
questions submitted as controlled following information in the inquiry: (1) widely varied, we are providing an
correspondence within certain time Name, title, address, phone number, and average burden hour for each inquiry.
frames. To facilitate FDA’s prompt entity of the person submitting the We estimate that it will take an average
consideration of the controlled inquiry; (2) a letter of authorization, if of 5 hours per inquiry for industry to
correspondence and to assist in meeting applicable; (3) the FDA-assigned control gather necessary information, prepare
the prescribed time frames, FDA number, submission date of the the request, and submit the request to
recommends including the following controlled correspondence on which the FDA. As a result, we estimate that it will
information in the inquiry: (1) Name, requestor is seeking clarification, a copy take an average of 7,480 total hours
title, address, phone number, and entity of that previous controlled annually for industry to prepare and
of the person submitting the inquiry; (2) correspondence, and FDA’s response to submit inquiries considered controlled
a letter of authorization, if applicable; the controlled correspondence; and (4) correspondence.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of
Submission of controlled correspondence responses per annual burden per Total hours
respondents respondent responses response
Generic drug manufacturers, related industry, and rep-
resentatives ...................................................................... 390 3.8 1,496 5 7,480
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access DEPARTMENT OF HEALTH AND SUMMARY: The Food and Drug
HUMAN SERVICES Administration (FDA or Agency) is
Persons with access to the Internet announcing an opportunity for public
may obtain the draft guidance at either Food and Drug Administration comment on the proposed collection of
https://www.fda.gov/Drugs/Guidance certain information by the Agency.
ComplianceRegulatoryInformation/ [Docket No. FDA–2011–N–0510]
Under the Paperwork Reduction Act of
Guidances/default.htm or https:// Agency Information Collection 1995 (PRA), Federal Agencies are
www.regulations.gov. Activities; Proposed Collection; required to publish notice in the
ethrower on DSK3G9T082PROD with NOTICES
Dated: October 30, 2017. Comment Request; Substances Federal Register concerning each
Anna K. Abram, Prohibited From Use in Animal Food or proposed collection of information,
Deputy Commissioner for Policy, Planning, Feed including each proposed extension of an
Legislation, and Analysis. AGENCY: Food and Drug Administration, existing collection of information, and
[FR Doc. 2017–23947 Filed 11–2–17; 8:45 am] HHS. to allow 60 days for public comment in
response to the notice. This notice
BILLING CODE 4164–01–P ACTION: Notice.
solicits comments on the information
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![51282 Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Notices
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of
21 CFR section responses per annual burden per Total hours
respondents respondent responses response
589.2001(f); request for designation .................................... 1 1 1 80 80
589.2001(f); response to request for review by FDA .......... 1 1 1 26 26
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate of the reporting burden DEPARTMENT OF HEALTH AND The 1984 amendments include what
for designation under § 589.2001(f) is HUMAN SERVICES is now section 505(j)(7) of the Federal
based on estimates in the final rule Food, Drug, and Cosmetic Act (21 U.S.C.
entitled, ‘‘Substances Prohibited From Food and Drug Administration 355(j)(7)), which requires FDA to
Use in Animal Food or Feed,’’ publish a list of all approved drugs.
published in the Federal Register of [Docket No. FDA–2017–P–2044] FDA publishes this list as part of the
April 25, 2008, our experience, and the ‘‘Approved Drug Products With
Determination That REVEX (Nalmefene Therapeutic Equivalence Evaluations,’’
average number of requests for
Hydrochloride Injection), 0.1 Milligram which is known generally as the
designation received in the past 3 years.
Base/Milliliter and 1.0 Milligram Base/ ‘‘Orange Book.’’ Under FDA regulations,
The reporting burden for § 589.2001(f) is
Milliliter, Was Not Withdrawn From a drug is removed from the list if the
minimal because requests for Sale for Reasons of Safety or
designation are seldom submitted. Since Agency withdraws or suspends
Effectiveness approval of the drug’s NDA or ANDA
2009, we have received two requests for
AGENCY: Food and Drug Administration, for reasons of safety or effectiveness or
designation. In the last 3 years, we have
HHS. if FDA determines that the listed drug
not received any new requests for was withdrawn from sale for reasons of
designation; therefore, we estimate that ACTION: Notice. safety or effectiveness (21 CFR 314.162).
one or fewer requests for designation A person may petition the Agency to
will be submitted annually. Although SUMMARY: The Food and Drug
Administration (FDA or Agency) has determine, or the Agency may
we have not received any new requests determine on its own initiative, whether
for designation in the last 3 years, we determined that REVEX (nalmefene
hydrochloride injection), 0.1 milligram a listed drug was withdrawn from sale
believe these information collection for reasons of safety or effectiveness.
(mg) base/milliliter (mL) and 1.0 mg
provisions should be extended to This determination may be made at any
base/mL, was not withdrawn from sale
provide for the potential future need of time after the drug has been withdrawn
for reasons of safety or effectiveness.
a foreign government to request This determination will allow FDA to from sale, but must be made prior to
designation under § 589.2001(f). Table approve abbreviated new drug approving an ANDA that refers to the
2, row 1 presents the expected burden applications (ANDAs) for REVEX listed drug (§ 314.161 (21 CFR 314.161)).
of requests for designation. Countries (nalmefene hydrochloride injection), 0.1 FDA may not approve an ANDA that
designated under § 589.2001(f) are mg base/mL and 1.0 mg base/mL, if all does not refer to a listed drug.
subject to review by FDA to ensure that REVEX (nalmefene hydrochloride
other legal and regulatory requirements
their designation remains appropriate. injection), 0.1 mg base/mL and 1.0 mg
are met.
We assume a country’s response to a base/mL, is the subject of NDA 20–459,
FOR FURTHER INFORMATION CONTACT: currently held by West-Ward
request for review will take about one Kelley Nduom, Center for Drug
third the time and effort of a request for Pharmaceuticals International Limited,
Evaluation and Research, Food and and initially approved on April 17,
designation. Table 2, row 2 presents the Drug Administration, 10903 New 1995. REVEX is indicated for the
expected burden of a request for review. Hampshire Ave., Bldg. 51, Rm. 6221, complete or partial reversal of opioid
The burden for this information Silver Spring, MD 20993–0002, 301– drug effects, including respiratory
collection has not changed since the last 796–8597. depression, induced by either natural or
OMB approval. SUPPLEMENTARY INFORMATION: In 1984, synthetic opioids. REVEX is also
Dated: October 24, 2017. Congress enacted the Drug Price indicated in the management of known
Anna K. Abram, Competition and Patent Term or suspected opioid overdose.
Restoration Act of 1984 (Pub. L. 98–417) In a letter dated June 5, 2009, Baxter
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
(the 1984 amendments), which Healthcare Corporation, the NDA holder
authorized the approval of duplicate at the time, notified FDA that the
[FR Doc. 2017–23948 Filed 11–2–17; 8:45 am]
versions of drug products under an manufacturing and distribution of
BILLING CODE 4164–01–P
ANDA procedure. ANDA applicants REVEX (nalmefene hydrochloride
must, with certain exceptions, show that injection), 0.1 mg base/mL and 1.0 mg
the drug for which they are seeking base/mL, had been discontinued on May
approval contains the same active 21, 2008, for business reasons. REVEX
ingredient in the same strength and (nalmefene hydrochloride injection), 0.1
ethrower on DSK3G9T082PROD with NOTICES
dosage form as the ‘‘listed drug,’’ which mg base/mL and 1.0 mg base/mL, is
is a version of the drug that was currently listed in the ‘‘Discontinued
previously approved. ANDA applicants Drug Product List’’ section of the Orange
do not have to repeat the extensive Book.
clinical testing otherwise necessary to Nirsum Pharmaceuticals, LLC,
gain approval of a new drug application submitted a citizen petition dated
(NDA). March 31, 2017 (Docket No. FDA–2017–
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Document Created: 2018-10-25 10:21:09
Document Modified: 2018-10-25 10:21:09
| 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 January 2, 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 | 82 FR 51279 |
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