80 FR 60153 - Agency Information Collection Activities; Proposed Collection; Comment Request; Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 192 (October 5, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 192 (October 5, 2015)
| Page Range | 60153-60157 | |
| FR Document | 2015-25155 |
[Federal Register Volume 80, Number 192 (Monday, October 5, 2015)] [Notices] [Pages 60153-60157] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-25155] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0559] Agency Information Collection Activities; Proposed Collection; Comment Request; Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 this notice. This notice solicits comments on the collection of information contained in the Public Health Service (PHS) guideline entitled ``PHS Guideline on Infectious Disease Issues in Xenotransplantation'' dated January 19, 2001. DATES: Submit either electronic or written comments on the collection of information by December 4, 2015. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the [[Page 60154]] 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2012-N-0559 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [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: (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. PHS Guideline on Infectious Disease Issues in Xenotransplantation OMB Control Number 0910-0456--Extension The statutory authority to collect this information is provided under sections 351 and 361 of the PHS Act (42 U.S.C. 262 and 264) and the provisions of the Federal Food, Drug, and Cosmetic Act that apply to drugs (21 U.S.C. 301 et seq.). The PHS guideline recommends procedures to diminish the risk of transmission of infectious agents to the xenotransplantation product recipient and to the general public. The PHS guideline is intended to address public health issues raised by xenotransplantation, through identification of general principles of prevention and control of infectious diseases associated with xenotransplantation that may pose a hazard to the public health. The collection of information described in this guideline is intended to provide general guidance on the following topics: (1) The development of xenotransplantation clinical protocols; (2) the preparation of submissions to FDA; and (3) the conduct of xenotransplantation clinical trials. Also, the collection of information will help ensure that the sponsor maintains important information in a cross-referenced system that links the relevant records of the xenotransplantation product recipient, xenotransplantation product, source animal(s), animal procurement center, and significant nosocomial exposures. The PHS guideline describes an occupational health service program for the protection of health care workers involved in xenotransplantation procedures, caring for xenotransplantation product recipients, and performing associated laboratory testing. The PHS guideline is intended to protect the public health and to help ensure the safety of using xenotransplantation products in humans by preventing the introduction, transmission, and spread of infectious diseases associated with xenotransplantation. The PHS guideline also recommends that certain specimens and records be maintained for 50 years beyond the date of the xenotransplantation. These include: (1) Records linking each xenotransplantation product recipient with relevant health records of the source animal, herd or colony, and the specific organ, tissue, or cell type included in or used in the manufacture of the product (section 3.2.7.1); (2) aliquots of serum samples from randomly selected animal and specific [[Page 60155]] disease investigations (section 3.4.3.1); (3) source animal biological specimens designated for PHS use (section 3.7.1); animal health records (section 3.7.2), including necropsy results (section 3.6.4); and (4) recipients' biological specimens (section 4.1.2). The retention period is intended to assist health care practitioners and officials in surveillance and in tracking the source of an infection, disease, or illness that might emerge in the recipient, the source animal, or the animal herd or colony after a xenotransplantation. The recommendation for maintaining records for 50 years is based on clinical experience with several human viruses that have presented problems in human to human transplantation and are therefore thought to share certain characteristics with viruses that may pose potential risks in xenotransplantation. These characteristics include long latency periods and the ability to establish persistent infections. Several also share the possibility of transmission among individuals through intimate contact with human body fluids. Human immunodeficiency virus (HIV) and Human T-lymphotropic virus are human retroviruses. Retroviruses contain ribonucleic acid that is reverse-transcribed into deoxyribonucleic acid (DNA) using an enzyme provided by the virus and the human cell machinery. That viral DNA can then be integrated into the human cellular DNA. Both viruses establish persistent infections and have long latency periods before the onset of disease; 10 years and 40 to 60 years, respectively. The human hepatitis viruses are not retroviruses, but several share with HIV the characteristic that they can be transmitted through body fluids, can establish persistent infections, and have long latency periods, e.g., approximately 30 years for hepatitis C. In addition, the PHS guideline recommends that a record system be developed that allows easy, accurate, and rapid linkage of information among the specimen archive, the recipient's medical records, and the records of the source animal for 50 years. The development of such a record system is a one-time burden. Such a system is intended to cross- reference and locate relevant records of recipients, products, source animals, animal procurement centers, and nosocomial exposures. Respondents to this collection of information are the sponsors of clinical studies of investigational xenotransplantation products under investigational new drug applications (INDs) and xenotransplantation product procurement centers, referred to as source animal facilities. There are an estimated three respondents who are sponsors of INDs that include protocols for xenotransplantation in humans and five clinical centers doing xenotransplantation procedures. Other respondents for this collection of information are an estimated four source animal facilities which provide source xenotransplantation product material to sponsors for use in human xenotransplantation procedures. These four source animal facilities keep medical records of the herds/colonies as well as the medical records of the individual source animal(s). The burden estimates are based on FDA's records of xenotransplantation- related INDs and estimates of time required to complete the various reporting, recordkeeping, and third-party disclosure tasks described in the PHS guideline. FDA is requesting an extension of OMB approval for the following reporting, recordkeeping, and third-party disclosure recommendations in the PHS guideline: Table 1--Reporting Recommendations ------------------------------------------------------------------------ PHS guideline Section Description ------------------------------------------------------------------------ 3.2.7.2................................... Notify sponsor or FDA of new archive site when the source animal facility or sponsor ceases operations. ------------------------------------------------------------------------ Table 2--Recordkeeping Recommendations ------------------------------------------------------------------------ PHS guideline section Description ------------------------------------------------------------------------ 3.2.7..................................... Establish records linking each xenotransplantation product recipient with relevant records. 4.3....................................... Sponsor to maintain cross- referenced system that links all relevant records (recipient, product, source animal, animal procurement center, and nosocomial exposures). 3.4.2..................................... Document results of monitoring program used to detect introduction of infectious agents which may not be apparent clinically. 3.4.3.2................................... Document full necropsy investigations including evaluation for infectious etiologies. 3.5.1..................................... Justify shortening a source animal's quarantine period of 3 weeks prior to xenotransplantation product procurement. 3.5.2..................................... Document absence of infectious agent in xenotransplantation product if its presence elsewhere in source animal does not preclude using it. 3.5.4..................................... Add summary of individual source animal record to permanent medical record of the xenotransplantation product recipient. 3.6.4..................................... Document complete necropsy results on source animals (50-year record retention). 3.7....................................... Link xenotransplantation product recipients to individual source animal records and archived biologic specimens. 4.2.3.2................................... Record baseline sera of xenotransplantation health care workers and specific nosocomial exposure. 4.2.3.3 and 4.3.2......................... Keep a log of health care workers' significant nosocomial exposure(s). 4.3.1..................................... Document each xenotransplant procedure. 5.2....................................... Document location and nature of archived PHS specimens in health care records of xenotransplantation product recipient and source animal. ------------------------------------------------------------------------ Table 3--Disclosure Recommendations ------------------------------------------------------------------------ PHS Guideline Section Description ------------------------------------------------------------------------ 3.2.7.2................................... Notify sponsor or FDA of new archive site when the source animal facility or sponsor ceases operations. 3.4....................................... Standard operating procedures (SOPs) of source animal facility should be available to review bodies. 3.5.1..................................... Include increased infectious risk in informed consent if source animal quarantine period of 3 weeks is shortened. 3.5.4..................................... Sponsor to make linked records described in section 3.2.7 available for review. 3.5.5..................................... Source animal facility to notify clinical center when infectious agent is identified in source animal or herd after xenotransplantation product procurement. ------------------------------------------------------------------------ [[Page 60156]] FDA estimates the burden for this collection of information as follows: Table 4--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of PHS guideline section Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- 3.2.7.2 \2\............................... 1 1 1 0.50 (30 minutes)....................... 0.50 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection information. \2\ FDA is using 1 animal facility or sponsor for estimation purposes. Table 5--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average burden PHS guideline section Number of records per Total annual per Total recordkeepers recordkeeper records recordkeeping hours ---------------------------------------------------------------------------------------------------------------- 3.2.7 \2\............................ 1 1 1 16 16 4.3 \3\.............................. 3 1 3 0.75 (45 2.25 minutes) 3.4.2 \4\............................ 3 10.67 32 0.25 (15 8 minutes) 3.4.3.2 \5\.......................... 3 2.67 8 0.25 (15 2 minutes) 3.5.1 \6\............................ 3 0.33 1 0.50 (30 0.50 minutes) 3.5.2 \6\............................ 3 0.33 1 0.25 (15 0.25 minutes) 3.5.4................................ 3 1 3 0.17 (10 0.51 minutes) 3.6.4 \7\............................ 3 2.67 8 0.25 (15 2 minutes) 3.7 \7\.............................. 4 2 8 0.08 (5 0.64 minutes) 4.2.3.2 \8\.......................... 5 25 125 0.17 (10 21.25 minutes) 4.2.3.2 \6\.......................... 5 0.20 1 0.17 (10 0.17 minutes) 4.2.3.3 and 4.3.2 \6\................ 5 0.20 1 0.17 (10 0.17 minutes) 4.3.1................................ 3 1 3 0.25 (15 0.75 minutes) 5.2 \9\.............................. 3 4 12 0.08 (5 0.96 minutes) -------------------------------------------------------------------------- Total............................ ............... ............... ............... ............... 55.45 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection information. \2\ A one-time burden for new respondents to set up a recordkeeping system linking all relevant records. FDA is using one new sponsor for estimation purposes. \3\ FDA estimates there is minimal recordkeeping burden associated with maintaining the record system. \4\ Monitoring for sentinel animals (subset representative of herd) plus all source animals. There are approximately 6 sentinel animals per herd x 1 herd per facility x 4 facilities = 24 sentinel animals. There are approximately 8 source animals per year (see footnote 7 of this table); 24 + 8 = 32 monitoring records to document. \5\ Necropsy for animal deaths of unknown cause estimated to be approximately 2 per year x 1 herd per facility x 4 facilities = 8. \6\ Has not occurred in the past 3 years and is expected to continue to be a rare occurrence. \7\ On average 2 source animals are used for preparing xenotransplantation product material for one recipient. The average number of source animals is 2 source animals per recipients x 4 annually = 8 source animals per year. (See footnote 5 of table 6.) \8\ FDA estimates ther are 5 clinical centers doing xenotransplantation procedures x approximately 25 health care workers involved per center = 125 health care workers. \9\ Eight source animal records + 4 recipient records = 12 total records. Table 6--Estimated Annual Third-Party Disclosure Burden -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Number of disclosures Total annual PHS guideline section respondents per disclosures Average burden per disclosure Total hours respondent -------------------------------------------------------------------------------------------------------------------------------------------------------- 3.2.7.2 \2\................................. 1 1 1 0.50 (30 minutes)......................... 0.50 3.4 \3\..................................... 4 0.25 1 0.08 (5 minutes).......................... 0.08 3.5.1 \4\................................... 4 0.25 1 0.25 (15 minutes)......................... 0.25 3.5.4 \5\................................... 4 1 4 0.50 (30 minutes)......................... 2 3.5.5 \4\................................... 4 0.25 1 0.25 (15 minutes)......................... 0.25 ----------------------------------------------------------------------------------------------------------- Total................................... .............. .............. .............. .......................................... 3.08 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ FDA is using one animal facility or sponsor for estimation purposes. \3\ FDA's records indicate that an average of 1 IND is expected to be submitted per year. \4\ To our knowledge, has not occurred in the past 3 years and is expected to continue to be a rare occurrence. \5\ Based on an estimate of 12 patients treated over a 3-year period, the average number of xenotransplantation product recipients per year is estimated to be 4. Because of the potential risk for cross-species transmission of pathogenic persistent virus, the guideline recommends that health records be retained for 50 years. Since these records are medical records, the retention of such records for up to 50 years is not information subject to the PRA (5 CFR 1320.3(h)(5)). Also, because of the limited number of clinical studies with small patient populations, the number of records is expected to be insignificant at this time. Information collections in this guideline not included in tables 1 [[Page 60157]] through 6 can be found under existing regulations and approved under the OMB control numbers as follows: (1) ``Current Good Manufacturing Practice for Finished Pharmaceuticals,'' 21 CFR 211.1 through 211.208, approved under OMB control number 0910-0139; (2) ``Investigational New Drug Application,'' 21 CFR 312.1 through 312.160, approved under OMB control number 0910-0014; and (3) information included in a biologics license application, 21 CFR 601.2, approved under OMB control number 0910-0338. (Although it is possible that a xenotransplantation product may not be regulated as a biological product (e.g., it may be regulated as a medical device), FDA believes, based on its knowledge and experience with xenotransplantation, that any xenotransplantation product subject to FDA regulation within the next 3 years will most likely be regulated as a biological product.) However, FDA recognized that some of the information collections go beyond approved collections; assessments for these burdens are included in tables 1 through 6. In table 7, FDA identifies those collections of information activities that are already encompassed by existing regulations or are consistent with voluntary standards which reflect industry's usual and customary business practice. Table 7--Collection of Information Required by Current Regulations and Standards ------------------------------------------------------------------------ 21 CFR Section Description of (unless PHS guideline section collection of otherwise information activity stated) ------------------------------------------------------------------------ 2.2.1............................ Document offsite 312.52. collaborations. 2.5.............................. Sponsor ensures 312.62(c). counseling patient + family + contacts. 3.1.1 and 3.1.6.................. Document well- 312.23(a)(7)(a) characterized and 211.84. health history and lineage of source animals. 3.1.8............................ Registration with 42 CFR 71.53. and import permit from the Centers for Disease Control and Prevention. 3.2.2............................ Document 312.52. collaboration with accredited microbiology labs. 3.2.3............................ Procedures to ensure 9 CFR parts 1, the humane care of 2, and 3 and animals. PHS Policy.\1\ 3.2.4............................ Procedures AAALAC consistent for International accreditation by Rules of the Association for Accreditation Assessment and \2\ and NRC Accreditation of Guide.\3\ Laboratory Animal Care International (AAALAC International) and consistent with the National Research Council's (NRC) Guide. 3.2.5, 3.4, and 3.4.1............ Herd health 211.100 and maintenance and 211.122. surveillance to be documented, available, and in accordance with documented procedures; record standard veterinary care. 3.2.6............................ Animal facility SOPs PHS Policy.\1\ 3.3.3............................ Validate assay 211.160(a). methods. 3.6.1............................ Procurement and 211.100 and processing of 211.122. xenografts using documented aseptic conditions. 3.6.2............................ Develop, implement, 211.84(d) and and enforce SOP's 211.122(c). for procurement and screening processes. 3.6.4............................ Communicate to FDA 312.32(c). animal necropsy findings pertinent to health of recipient. 3.7.1............................ PHS specimens to be 312.23(a)(6). linked to health records; provide to FDA justification for types of tissues, cells, and plasma, and quantities of plasma and leukocytes collected. 4.1.1............................ Surveillance of 312.23(a)(6)(ii xenotransplant i)(f) and (g), recipient; sponsor and 312.62(b) ensures and (c). documentation of surveillance program life-long (justify >2 yrs.); investigator case histories (2 yrs. after investigation is discontinued). 4.1.2............................ Sponsor to justify 211.122. amount and type of reserve samples. 4.1.2.2.......................... System for prompt 312.57(a). retrieval of PHS specimens and linkage to medical records (recipient and source animal). 4.1.2.3.......................... Notify FDA of a 312.32. clinical episode potentially representing a xenogeneic infection. 4.2.2.1.......................... Document 312.52. collaborations (transfer of obligation). 4.2.3.1.......................... Develop educational 312.50. materials (sponsor provides investigators with information needed to conduct investigation properly). 4.3.............................. Sponsor to keep 312.57 and records of receipt, 312.62(b). shipment, and disposition of investigative drug; investigator to keep records of case histories. ------------------------------------------------------------------------ \1\ The ``Public Health Service Policy on Humane Care and Use of Laboratory Animals'' (http://www.grants.nih.gov/grants/olaw/references/phspol.htm). \2\ AAALAC International Rules of Accreditation (http://www.aaalac.org/accreditation/rules.cfm). \3\ The NRC's ``Guide for the Care and Use of Laboratory Animals.'' Dated: September 29, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-25155 Filed 10-2-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 192 / Monday, October 5, 2015 / Notices 60153
several confirmed deaths in the United dependence, abuse, and risks to the DEPARTMENT OF HEALTH AND
States. On July 17, 2015, Acetylfentanyl public health, thereby recommending HUMAN SERVICES
was temporarily placed into Schedule I that Methoxetamine not be placed under
of the CSA for 2 years upon finding that international control but be kept under Food and Drug Administration
it posed an imminent hazard to the international surveillance. [Docket No. FDA–2012–N–0559]
public safety. The Attorney General,
though, may extend this temporary IV. Opportunity To Submit Domestic Agency Information Collection
scheduling for up to 1 year. Information Activities; Proposed Collection;
a-Pyrrolidinovalerophenone (a-PVP Comment Request; Public Health
or alpha-PVP) is a synthetic cathinone As required by section 201(d)(2)(A) of
Service Guideline on Infectious
structurally and pharmacologically the CSA (21 U.S.C. 811(d)(2)(A)), FDA,
Disease Issues in Xenotransplantation
similar to amphetamine, 3,4- on behalf of the Department of Health
methylenedioxymethamphetamine and Human Services (HHS), invites AGENCY: Food and Drug Administration,
(MDMA); cathinone; and other related interested persons to submit comments HHS.
substances. Effects reported by abusers regarding the 10 named drugs. Any ACTION: Notice.
of synthetic cathinone substances comments received will be considered
include euphoria; sense of well-being; SUMMARY: The Food and Drug
by HHS when it prepares a scientific
and increased sociability, energy, Administration (FDA) is announcing an
and medical evaluation of these drugs.
empathy, alertness, and concentration opportunity for public comment on the
HHS will forward a scientific and
and focus. Abusers also report proposed collection of certain
medical evaluation of these drugs to information by the Agency. Under the
experiencing unwanted effects such as WHO, through the Secretary of State, for
tremor, vomiting, agitation, sweating, Paperwork Reduction Act of 1995 (the
WHO’s consideration in deciding PRA), Federal Agencies are required to
fever, and chest pain. Other adverse or whether to recommend international
toxic effects that have been reported publish notice in the Federal Register
control/decontrol of any of these drugs. concerning each proposed collection of
with the abuse of synthetic cathinones Such control could limit, among other
include tachycardia, hypertension, information, including each proposed
things, the manufacture and distribution extension of an existing collection of
hyperthermia, mydriasis,
(import/export) of these drugs and could information, and to allow 60 days for
rhabdomyolysis, hyponatremia,
seizures, altered mental status (e.g., impose certain recordkeeping public comment in response to this
paranoia, hallucinations, or delusions), requirements on them. notice. This notice solicits comments on
and even death. On March 7, 2014, Although FDA is, through this notice, the collection of information contained
alpha-PVP was temporarily placed into requesting comments from interested in the Public Health Service (PHS)
Schedule I of the CSA for 2 years upon persons which will be considered by guideline entitled ‘‘PHS Guideline on
finding that it posed an imminent HHS when it prepares an evaluation of Infectious Disease Issues in
hazard to the public safety. The these drugs, HHS will not now make Xenotransplantation’’ dated January 19,
Attorney General, though, may extend 2001.
any recommendations to WHO
this temporary scheduling for up to 1 regarding whether any of these drugs DATES: Submit either electronic or
year. should be subjected to international written comments on the collection of
4-Fluoroamphetamine (4–FA) is a information by December 4, 2015.
controls. Instead, HHS will defer such
psychoactive substance of the ADDRESSES: You may submit comments
consideration until WHO has made
phenethylamine and substituted as follows:
official recommendations to the
amphetamine chemical classes and
produces stimulant effects. 4–FA is not Commission on Narcotic Drugs, which Electronic Submissions
currently controlled in the United States are expected to be made in early 2016. Submit electronic comments in the
under the CSA. Any HHS position regarding following way:
Para-Methyl-4-methylaminorex (4,4’- international control of these drugs will • Federal eRulemaking Portal: http://
DMAR) is a derivative of the stimulant be preceded by another Federal Register www.regulations.gov. Follow the
drug 4-methylaminorex and has been notice soliciting public comments, as instructions for submitting comments.
involved in several deaths in the United required by section 201(d)(2)(B) of the Comments submitted electronically,
States. 4,4’-DMAR is not currently CSA. including attachments, to http://
controlled in the United States under www.regulations.gov will be posted to
V. Electronic Access the docket unchanged. Because your
the CSA.
Para-Methoxymethylamphetamine Persons with access to the Internet comment will be made public, you are
(PMMA) is a substituted amphetamine may obtain the document at either solely responsible for ensuring that your
of the phenethylamine class, as well as http://www.fda.gov/Drugs/Guidance comment does not include any
a structural analog of para- ComplianceRegulatoryInformation/ confidential information that you or a
methoxyamphetamine (PMA) which third party may not wish to be posted,
Guidances/default.htm or http://
produces effects similar but not such as medical information, your or
www.regulations.gov.
identical to that of MDMA. PMMA is anyone else’s Social Security number, or
not currently controlled in the United Dated: September 29, 2015. confidential business information, such
States under the CSA. Leslie Kux, as a manufacturing process. Please note
mstockstill on DSK4VPTVN1PROD with NOTICES
2-(ethylamino)-2-(3-methoxyphenyl)- Associate Commissioner for Policy. that if you include your name, contact
cyclohexanone (Methoxetamine or [FR Doc. 2015–25201 Filed 10–2–15; 8:45 am]
information, or other information that
MXE) is an arylcyclohexamine and is identifies you in the body of your
BILLING CODE 4164–01–P
not currently controlled under the CSA comments, that information will be
in the United States. At its 36th posted on http://www.regulations.gov.
meeting, the WHO Expert Committee on • If you want to submit a comment
Drug Dependence noted the with confidential information that you
insufficiency of data regarding do not wish to be made available to the
VerDate Sep<11>2014 18:34 Oct 02, 2015 Jkt 238001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\05OCN1.SGM 05OCN1](https://thefederalregister.org/doc/80_FR_60345/page/1.svg)
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through 6 can be found under existing under OMB control number 0910–0338. collections go beyond approved
regulations and approved under the (Although it is possible that a collections; assessments for these
OMB control numbers as follows: (1) xenotransplantation product may not be burdens are included in tables 1 through
‘‘Current Good Manufacturing Practice regulated as a biological product (e.g., it 6.
for Finished Pharmaceuticals,’’ 21 CFR may be regulated as a medical device),
In table 7, FDA identifies those
211.1 through 211.208, approved under FDA believes, based on its knowledge
collections of information activities that
OMB control number 0910–0139; (2) and experience with
‘‘Investigational New Drug xenotransplantation, that any are already encompassed by existing
Application,’’ 21 CFR 312.1 through xenotransplantation product subject to regulations or are consistent with
312.160, approved under OMB control FDA regulation within the next 3 years voluntary standards which reflect
number 0910–0014; and (3) information will most likely be regulated as a industry’s usual and customary business
included in a biologics license biological product.) However, FDA practice.
application, 21 CFR 601.2, approved recognized that some of the information
TABLE 7—COLLECTION OF INFORMATION REQUIRED BY CURRENT REGULATIONS AND STANDARDS
21 CFR Section
PHS guideline section Description of collection of information activity (unless otherwise stated)
2.2.1 .................................... Document offsite collaborations .................................................................... 312.52.
2.5 ....................................... Sponsor ensures counseling patient + family + contacts ............................. 312.62(c).
3.1.1 and 3.1.6 .................... Document well-characterized health history and lineage of source animals 312.23(a)(7)(a) and 211.84.
3.1.8 .................................... Registration with and import permit from the Centers for Disease Control 42 CFR 71.53.
and Prevention.
3.2.2 .................................... Document collaboration with accredited microbiology labs .......................... 312.52.
3.2.3 .................................... Procedures to ensure the humane care of animals ...................................... 9 CFR parts 1, 2, and 3 and PHS
Policy.1
3.2.4 .................................... Procedures consistent for accreditation by the Association for Assessment AAALAC International Rules of Ac-
and Accreditation of Laboratory Animal Care International (AAALAC creditation 2 and NRC Guide.3
International) and consistent with the National Research Council’s
(NRC) Guide.
3.2.5, 3.4, and 3.4.1 ............ Herd health maintenance and surveillance to be documented, available, 211.100 and 211.122.
and in accordance with documented procedures; record standard veteri-
nary care.
3.2.6 .................................... Animal facility SOPs ...................................................................................... PHS Policy.1
3.3.3 .................................... Validate assay methods ................................................................................ 211.160(a).
3.6.1 .................................... Procurement and processing of xenografts using documented aseptic con- 211.100 and 211.122.
ditions.
3.6.2 .................................... Develop, implement, and enforce SOP’s for procurement and screening 211.84(d) and 211.122(c).
processes.
3.6.4 .................................... Communicate to FDA animal necropsy findings pertinent to health of re- 312.32(c).
cipient.
3.7.1 .................................... PHS specimens to be linked to health records; provide to FDA justification 312.23(a)(6).
for types of tissues, cells, and plasma, and quantities of plasma and leu-
kocytes collected.
4.1.1 .................................... Surveillance of xenotransplant recipient; sponsor ensures documentation 312.23(a)(6)(iii)(f) and (g), and
of surveillance program life-long (justify >2 yrs.); investigator case his- 312.62(b) and (c).
tories (2 yrs. after investigation is discontinued).
4.1.2 .................................... Sponsor to justify amount and type of reserve samples ............................... 211.122.
4.1.2.2 ................................. System for prompt retrieval of PHS specimens and linkage to medical 312.57(a).
records (recipient and source animal).
4.1.2.3 ................................. Notify FDA of a clinical episode potentially representing a xenogeneic in- 312.32.
fection.
4.2.2.1 ................................. Document collaborations (transfer of obligation) ........................................... 312.52.
4.2.3.1 ................................. Develop educational materials (sponsor provides investigators with infor- 312.50.
mation needed to conduct investigation properly).
4.3 ....................................... Sponsor to keep records of receipt, shipment, and disposition of investiga- 312.57 and 312.62(b).
tive drug; investigator to keep records of case histories.
1 The ‘‘Public Health Service Policy on Humane Care and Use of Laboratory Animals’’ (http://www.grants.nih.gov/grants/olaw/references/
phspol.htm).
2 AAALAC International Rules of Accreditation (http://www.aaalac.org/accreditation/rules.cfm).
3 The NRC’s ‘‘Guide for the Care and Use of Laboratory Animals.’’
Dated: September 29, 2015.
Leslie Kux,
mstockstill on DSK4VPTVN1PROD with NOTICES
Associate Commissioner for Policy.
[FR Doc. 2015–25155 Filed 10–2–15; 8:45 am]
BILLING CODE 4164–01–P
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Document Created: 2015-12-15 08:52:34
Document Modified: 2015-12-15 08:52:34
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
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| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 60153 |
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