reglab/statecodes huggingface dataset:
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 60 - Food And Drug Products › Subpart 60-3 - Diabetes Equipment And Related Supplies › Section 60-3.1 - Equipment and related supplies

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 equipment and related supplies which may be medically necessary for the
					 treatment of diabetes shall include but not be limited to the following:
(1) lancets and automatic lancing
					 devices;
(2) glucose test
					 strips;
(3) blood glucose
					 monitors;
(4) blood glucose
					 monitors for the visually impaired;
(5) control solutions used in blood glucose
					 monitors;
(6) diabetes data
					 managemeny systems for management of blood glucose;
(7) urine testing products for glucose and
					 ketones
(8) oral anti-diabetic
					 agents used to reduce blood sugar levels;
(9) alcohol swabs;
(10) syringes;
(11) injection aids including insulin drawing
					 up devises for the visually impaired;
(12) cartridges for the visually
					 impaired;
(13) disposal insulin
					 cartridges and pen cartridges;
(14)
					 all insulin preparations;
(15)
					 insulin pumps and equipment for the use of the pump including
					 batteries;
(16) insulin infusion
					 devices;
(17) oral agents for
					 treating hypoglycemia such as glucose tablets and gels; and
(18) glucagon for injection to increase blood
					 glucose concentration.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 60 - Food And Drug Products › Subpart 60-4 - Drug Take Back › Section 60-4.1 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
For purposes of this Subpart, the following terms shall
						have the following meanings.
(a)
					 "Authorized collector" means
(1) a person,
					 company, corporation or other entity that is registered with the DEA to collect
					 controlled substances for the purposes of safe disposal and destruction;
					 or
(2) a law enforcement agency;
					 or
(3) a person, company,
					 corporation or other entity authorized by the Department to provide alternative
					 collection methods for covered drugs that are not controlled
					 substances.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 60 - Food And Drug Products › Subpart 60-4 - Drug Take Back › Section 60-4.2 - Convenience Standards for Certain Cities and Counties

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Authorized drug take back programs must
					 offer a minimum number of collection receptacles in cities and certain counties
					 with a population of 125,000 or more, according to the following convenience
					 standards:
(1) For the City of Buffalo: at
					 least one on-site collection receptacle per 10,000 population.
(2) For the City of Rochester: at least one
					 on-site collection receptacle per 10,000 population.
(3) For the City of Syracuse: at least one
					 on-site collection receptacle per 10,000 population.
(4) For the City of Yonkers: at least one
					 on-site collection receptacle per 10,000 population.
(5) For New York County: at least one on-site
					 collection receptacle per 10,000 population.
(6) For Richmond County: at least one on-site
					 collection receptacle per 10,000 population.
(7) For Queens County: at least one on-site
					 collection receptacle per 15,000 population.
(8) For Kings County: at least one on-site
					 collection receptacle per 20,000 population.
(9) For Bronx County: at least one on-site
					 collection receptacle per 20,000 population.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 60 - Food And Drug Products › Subpart 60-4 - Drug Take Back › Section 60-4.4 - Pharmacies Engaged in Drug Take Back

Current through Register Vol. 46, No. 28, July 10, 2024
Notwithstanding any provision of section 60-4.1, for the
						purposes of this section, a pharmacy shall also include any pharmacy located in
						the state and that, though not required to by Article 2-B of the Public Health
						Law, voluntarily participates in an authorized drug take back program.
						Pharmacies participating in drug take back shall:
(a) Be properly registered under section 6808  of the Education Law or, in the case
					 of nonresident pharmacies, be registered under section 6808-b  of the Education Law.
(b) If maintaining an onsite collection
					 receptacle, modify existing registration to obtain authorization from the DEA
					 to be a collector.
(c) Comply with
					 all federal laws and regulations concerning the disposal of controlled
					 substances.
(d) Notify the
					 Department and any contracted drug take back program operator, as applicable,
					 within 30 days of drug take back program discontinuance or change of address of
					 collection activity.
(e) If
					 maintaining a collection receptacle:
(1)
					 Utilize a collection receptacle that meets the requirements of section 60-4.5 
					 of this Subpart and all applicable federal laws and regulations.;
(2) Collection receptacle placement:
i. Receptacles accessible to the public,
					 shall be located in the immediate proximity of the registered pharmacy area
					 where prescription drugs are stored and be easily and regularly monitored by
					 the pharmacist or pharmacy staff; or
ii. receptacles located in a residential
					 health care facility shall be located in a secured area regularly monitored by
					 residential health care facility employees.
(3) Ensure proper operation of the collection
					 receptacle, which includes but is not limited to periodic monitoring to
					 determine when it is full; removing and replacing the inner liner when it is
					 full; and arranging for delivery of sealed inner liners and their contents to a
					 reverse distributor's registered location by common or contract carrier pickup
					 or by reverse distributor pickup;
(4) Ensure that receptacle box liners that
					 are removed are safely and securely stored until retrieved by the reverse
					 distributor or by common or contract carrier;
(5) Ensure that pharmacy employees do not
					 handle drugs for disposal, review the contents of the collection receptacle,
					 remove, count, weigh, consume, repurpose, restock, redispense, resell, or touch
					 items placed in the collection receptacle;
(6) Ensure the sealed inner liners and their
					 contents are shipped to a reverse distributor's registered location by common
					 or contract carrier or by licensed reverse distributor pickup at the licensed
					 pharmacy's or residential health care facility's premises;
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 60 - Food And Drug Products › Subpart 60-4 - Drug Take Back › Section 60-4.5 - Collection Receptacles

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Every
					 collection receptacle maintained at participating pharmacies and residential
					 health care facilities shall comply with all applicable state and federal laws
					 and regulations and:
1. Be securely fastened
					 to a permanent structure so that it cannot be removed;
2. Be a securely-locked,
					 substantially-constructed container with a permanent outer container and a
					 removable inner liner;
3. Feature
					 an outer container which shall include a small opening that allows contents to
					 be deposited into the inner liner, but which does not allow removal of the
					 inner liner's contents; and
4.
					 Display signage describing items eligible and not eligible for deposit in the
					 collection receptacle.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 60 - Food And Drug Products › Subpart 60-4 - Drug Take Back › Section 60-4.6 - Mail back envelopes and packages

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Pharmacies that provide a mail back
					 option as part of a drug take back program and all nonresident pharmacies that
					 distribute covered drugs to residents by mail shall:
(1) provide a prepaid package or envelope,
					 or
(2) provide a voucher for a
					 prepaid package or envelope, which includes patient education regarding the
					 drug take back program and safe drug disposal methods, upon dispensing a
					 covered drug. Patients shall be directed to mail their unused drugs using the
					 packages or envelopes.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 60 - Food And Drug Products › Subpart 60-4 - Drug Take Back › Section 60-4.7 - General Requirements

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Recordkeeping requirements.
(1)
					 Manufacturers, drug take back organizations, pharmacies and other authorized
					 collectors shall maintain all records required by this Part for a period of
					 five years.
(2) Records and
					 invoices required by this Part shall be readily available and promptly produced
					 for inspection and copying upon request by authorized representatives of the
					 Department's Bureau of Narcotic Enforcement, or the Department of Environmental
					 Conservation.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 61 - Research › Subpart 61-1 - Recombinant Dna Research And Activity › General › Section 61-1.1 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
As used in this Subpart:
(a) Commissioner means Commissioner of Health
						of the State of New York.
(b)
						Department means Department of Health of the State of New York.
(c) Guidelines means the recombinant DNA
						research guidelines of the National Institutes of Health of the Department of
						Health and Human Services, as amended and revised from time to time.
(d) NIH means the National Institutes of
						Health.
(e) P1, P2, P3, P4
						designate levels of physical containment in order of increasing safeguards
						against the escape of organisms.
(f) EK1, EK2, EK3 designate levels of
						biological containment for E. coli K-12 host-vector systems in order of
						increasing inability of organisms to survive outside of laboratory
						conditions.
(g) Class 1, class 2,
						class 3, class 4, class 5 designate classes of etiologic agents in order of
						increasing hazard according to Classification of Etiologic Agents on the Basis
						of Hazard issued by the Public Health Service of the Department of Health and
						Human Services, as revised by NIH.
(h) Institution means any public or private
						entity other than an individual, including State and local government
						agencies.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 61 - Research › Subpart 61-1 - Recombinant Dna Research And Activity › General › Section 61-1.2 - Repealed

Current through Register Vol. 46, No. 28, July 10, 2024
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 61 - Research › Subpart 61-1 - Recombinant Dna Research And Activity › General › Section 61-1.3 - Certification

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A certificate
						to engage in recombinant DNA activity will be issued by the commissioner only
						to an institution. Except as hereinafter provided, an institution will not be
						issued a certificate unless it:
(1)
						establishes an institutional biosafety committee (IBC) composed of members
						approved by the commissioner as satisfying the requirements of section
						61-1.31 
						of this Subpart; and
(2) submits a
						written assurance that it:
(i) will submit
						each recombinant DNA project to NIH, or other Federal agency designated by NIH,
						for approval where such approval is required by this Subpart or the NIH
						guidelines;
(ii) will file reports
						with the commissioner when requested by him showing the progress of recombinant
						DNA activity engaged in at the institution;
(iii) will not engage in recombinant DNA
						activity in any facility which does not comply with the NIH
						guidelines;
(iv) will conduct
						training programs satisfactory to the commissioner for all workers and service
						personnel with duties in recombinant DNA laboratories;
(v) will carry out health monitoring programs
						appropriate to each recombinant DNA activity engaged in;
(vi) has an emergency plan for accidents
						involving potentially hazardous materials involved in recombinant DNA activity;
						and
(vii) will comply with the
						requirements of article 32-A of the Public Health Law and this
						Subpart.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 61 - Research › Subpart 61-1 - Recombinant Dna Research And Activity › Containment › Section 61-1.10 - Containment; general

Current through Register Vol. 46, No. 28, July 10, 2024
Good microbiological practices shall be adhered to. All
						  personnel directly or indirectly involved in recombinant DNA activity shall be
						  instructed in aseptic techniques and the biology of organisms used in the
						  activity, in order that they shall be aware of potential biohazards. An
						  emergency plan shall describe the procedures to be followed in the event of an
						  accident contaminating personnel or the environment. The principal investigator
						  must ensure that everyone in the laboratory is familiar with both the potential
						  hazards of the work and the emergency plan. All personnel working with a
						  pathogen for which an effective vaccine is available should be immunized.
						  Serological monitoring, when appropriate, shall be provided.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 61 - Research › Subpart 61-1 - Recombinant Dna Research And Activity › Containment › Section 61-1.11 - Physical containment levels; p1 level

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Laboratory practices.
(1) Laboratory doors shall be kept closed
						while experiments are in progress.
(2) Work surfaces shall be decontaminated
						daily, and immediately following spills of organisms containing recombinant DNA
						molecules.
(3) All biological
						wastes shall be decontaminated before disposal. Other contaminated materials,
						such as glassware, animal cages and laboratory equipment, shall be
						decontaminated before washing, reuse or disposal.
(4) Mechanical pipetting devices shall be
						used; pipetting by mouth is prohibited.
(5) Eating, drinking, smoking, and storage of
						foods are not permitted in the laboratory area in which recombinant DNA
						materials are handled.
(6) Persons
						shall wash their hands after handling organisms containing recombinant DNA
						molecules, and when they leave the laboratory.
(7) Care shall be taken in the conduct of all
						procedures to minimize the creation of aerosols.
(8) Contaminated materials that are to be
						decontaminated at a site away from the laboratory shall be placed in a durable
						leak-proof container, which is closed before removal from the
						laboratory.
(9) An insect and
						rodent control program shall be instituted.
(10) The use of laboratory gowns, coats or
						uniforms is discretionary with the laboratory supervisor.
(11) Use of the hypodermic needle and syringe
						shall be avoided when alternative methods are available.
(12) The laboratory shall be kept neat and
						clean.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 61 - Research › Subpart 61-1 - Recombinant Dna Research And Activity › Containment › Section 61-1.12 - Physical containment levels; p2 level

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Laboratory practices.
(1) Laboratory doors shall be kept closed
						while experiments are in progress.
(2) Work surfaces shall be decontaminated
						daily, and immediately following spills of organisms containing recombinant DNA
						molecules.
(3) All laboratory
						wastes shall be steam-sterilized (autoclaved) before disposal. Other
						contaminated materials, such as glassware, animal cages, laboratory equipment
						and radioactive wastes, shall be decontaminated by a means demonstrated to be
						effective before washing, reuse or disposal.
(4) Mechanical pipetting devices shall be
						used; pipetting by mouth is prohibited.
(5) Eating, drinking, smoking, and storage of
						food are not permitted in the laboratory area in which recombinant DNA
						materials are handled.
(6) Persons
						shall wash their hands after handling organisms containing recombinant DNA
						molecules, and when they leave the laboratory.
(7) Care shall be exercised to minimize the
						creation of aerosols. For example, manipulations such as inserting a hot
						inoculating loop or needle into a culture, flaming an inoculation loop or
						needle so that it splatters, and forceful ejection of fluids from pipettes or
						syringes shall be avoided.
(8)
						Contaminated materials that are to be steam-sterilized (autoclaved) or
						decontaminated at a site away from the laboratory shall be placed in a durable
						leak-proof container, which is closed before removal from the
						laboratory.
(9) Only persons who
						have been advised of the nature of the research being conducted shall enter the
						laboratory.
(10) The universal
						biohazard sign shall be posted on all laboratory access doors when experiments
						requiring P2 containment are in progress. Freezers and refrigerators or other
						units used to store organisms containing recombinant DNA molecules shall also
						be posted with the universal biohazard sign.
(11) An insect and rodent control program
						shall be instituted.
(12) The use
						of laboratory gowns, coats, or uniforms is required. Laboratory clothing shall
						not be worn to the lunch room or outside of the building in which the
						laboratory is located.
(13) Animals
						not related to the experiment shall not be permitted in the
						laboratory.
(14) Use of the
						hypodermic needle and syringe shall be avoided when alternative methods are
						available.
(15) The laboratory
						shall be kept neat and clean.
(16)
						Experiments of lesser biohazard potential can be carried out concurrently in
						carefully demarcated areas of the same laboratory.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 61 - Research › Subpart 61-1 - Recombinant Dna Research And Activity › Containment › Section 61-1.15 - Shipment of recombinant dna

Current through Register Vol. 46, No. 28, July 10, 2024
For additional information on packaging and shipment,
						  see NIH Laboratory Safety Monograph.
Recombinant DNA molecules contained in an organism or
						  virus shall be shipped only as an etiologic agent under requirements of the
						  U.S. Public Health Service and the U.S. Department of Transportation (section
						  72.3, part 72, title 42, and sections 173.386 -.388, part 173, title 49, U.S.
						  Code of Federal Regulations) as specified in this section:
(a) Recombinant DNA molecules contained in an
						organism or virus requiring P1, P2, or P3 physical containment, when offered
						for transportation or transported, are subject to all requirements of section
						72.3(a)-(e), part 72, title 42 CFR, and sections 173.386 -.388, part 173, title
						49 CFR.
(b) Recombinant DNA
						molecules contained in an organism or virus requiring P4 physical containment,
						when offered for transportation or transported, are subject to the requirements
						listed under subdivision (a) of this section and are also subject to section
						72.3(f), part 72, title 42 CFR.
[FN*] For additional information on packaging and
						  shipment, see NIH Laboratory Safety Monograph.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 61 - Research › Subpart 61-1 - Recombinant Dna Research And Activity › Containment › Section 61-1.16 - Biological containment levels

Current through Register Vol. 46, No. 28, July 10, 2024
The following levels of biological containment (HV or
						  host-vector systems) for prokaryotes are established:
(a) HV1. A host-vector system which provides
						a moderate level of containment. Specific systems:
(1) EK1. The host is always E. coli K-12 or a
						derivative thereof, and the vectors include nonconjugative plasmids
						(e.g.,pSC101, ColE1, or derivatives thereof) and variants of bacteriophage,
						such as. The E. coli K-12 hosts shall not contain conjugation-proficient
						plasmids, whether autonomous or integrated, or generalized transducing
						phages.
(2) Other prokaryotes.
						Hosts and vectors shall be, at a minimum, comparable in containment to E. coli
						K-12 with a nonconjugative plasmid or bacteriophage vector.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 61 - Research › Subpart 61-1 - Recombinant Dna Research And Activity › Classes of Recombinant DNA Activity › Section 61-1.21 - Repealed

Current through Register Vol. 46, No. 28, July 10, 2024
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 61 - Research › Subpart 61-1 - Recombinant Dna Research And Activity › Classes of Recombinant DNA Activity › Section 61-1.24 - Repealed

Current through Register Vol. 46, No. 28, July 10, 2024
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 61 - Research › Subpart 61-1 - Recombinant Dna Research And Activity › Classes of Recombinant DNA Activity › Section 61-1.25 - Repealed

Current through Register Vol. 46, No. 28, July 10, 2024
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 61 - Research › Subpart 61-1 - Recombinant Dna Research And Activity › Roles and Responsibilities › Section 61-1.30 - Institution; responsibilities

Current through Register Vol. 46, No. 28, July 10, 2024
Except as otherwise provided by subdivision (c) of
						  section
						  61-1.3 
						  of this Subpart, the institution shall:
(a) submit to the commissioner a written
						assurance complying with the requirements of paragraph (2) of subdivision (a)
						of section
						61-1.3 
						of this Subpart unless it possess a certificate pursuant to subdivision (b) or
						(d) of said section;
(b) establish
						an institutional biosafety committee (IBC) that meets the requirements of
						section
						61-1.31 
						of this Subpart;
(c) ensure that
						the institutional biosafety committee is fulfilling its responsibilities at all
						times;
(d) ensure compliance of
						recombinant DNA activity with the requirements of this Subpart;
(e) if the institution is engaged in
						recombinant DNA activity at the P3 or P4 containments level, appoint a
						biological safety officer (BSO), who shall be a member of the IBC and carry out
						the duties specified in section
						61-1.32 
						of this Subpart;
(f) ensure that
						all principal investigators (PIs) comply with the provisions of section
						61-1.33 
						of this Subpart;
(g) ensure
						appropriate training for the IBC chairperson and members, the BSO, principal
						investigators (PIs), and laboratory staff regarding the requirements of article
						32-A of the Public Health Law and this Subpart, their implementation and
						laboratory safety;
(h) determine,
						in consultation with the local public health office when appropriate, the
						necessity and extent of health surveillance of personnel involved in
						recombinant DNA activity, including, but not limited to records of agents
						handled, active investigation of illnesses of personnel working with or exposed
						to recombinant DNA, and maintenance of serial serum samples;
(i) report within 30 days to the commissioner
						any significant problems with and violations of this Subpart and significant
						recombinant DNA activity-related accidents and illnesses, unless the
						institution determines that the PI or IBC has done so; and
(j) upon request, make available to the
						public any documents submitted to or received from the commissioner which he is
						required to make available to the public (e.g., reports of violations of this
						Subpart and of significant recombinant DNA activity-related accidents, and
						directives to modify projects). If comments are made by members of the public
						on IBC actions, the institution shall forward to the commissioner both the
						comments and the IBC's response.
See NIH Laboratory Safety Monograph for additional
							 medical surveillance information.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 61 - Research › Subpart 61-1 - Recombinant Dna Research And Activity › Roles and Responsibilities › Section 61-1.31 - Institutional biosafety committee; composition and duties

Current through Register Vol. 46, No. 28, July 10, 2024
(a) An institutional biosafety committee
						(IBC) shall be composed of not less than five persons, approved by the
						commissioner, who collectively have experience and expertise in recombinant DNA
						technology and the capability to assess the safety of proposed recombinant DNA
						activity and any potential risk to public health or the environment. At least
						two members shall not be affiliated with the institution (apart from their
						membership on the IBC) and shall represent the interest of the surrounding
						community with respect to health and protection of the environment. Members
						meet this requirement if, for example, they are officials of State or local
						public health or environmental protection agencies, members of other local
						governmental bodies, or persons active in medical, occupational health, or
						environmental concerns in the community. The biological safety officer (BSO),
						mandatory when activity is being conducted at the P3 and P4 levels, shall be a
						member. The membership should include individuals with expertise in recombinant
						DNA technology, biological safety and physical containment and include, or have
						available as consultants, persons knowledgeable in institutional commitments
						and policies, applicable law, standards of professional conduct and practice,
						community attitudes and the environment. At least one member should be from the
						laboratory technical staff. No member of a committee may be involved (except to
						provide information requested by the IBC) in the review or approval of activity
						in which he or she has been, or expects to be, engaged, or has a direct or
						conflicting interest.
(b) IBC
						meetings and minutes of meetings shall be open to the public, consistent with
						protection of privacy and proprietary interests.
(c) On behalf of the institution, the IBC
						shall:
(1) review for compliance with this
						Subpart all recombinant DNA activity as specified in section
						61-1.20 
						of this Subpart conducted at or sponsored by the institution, and approve those
						activities that it finds are in conformity with this Subpart. This review shall
						include:
(i) an independent assessment of the
						containment levels required by this Subpart for the proposed activity;
						and
(ii) an assessment of the
						facilities, procedures and practices, and of the training and expertise of the
						recombinant DNA personnel;[FN*]
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 61 - Research › Subpart 61-1 - Recombinant Dna Research And Activity › Roles and Responsibilities › Section 61-1.32 - Biological safety officer; duties

Current through Register Vol. 46, No. 28, July 10, 2024
The institution shall appoint a BSO if it engages in
						  recombinant DNA activity at the P3 or P4 containment level. The officer shall
						  be a member of the institutional biosafety committee (IBC). His or her duties
						  shall include (but need not be limited to):
(a) ensuring through periodic inspections
						that laboratory standards are rigorously followed;
(b) reporting to the IBC and the institution
						all significant problems with and violations of this Subpart and all
						significant recombinant DNA activity-related accidents and illnesses of which
						the BSO becomes aware, unless the BSO determines that the principal
						investigator (PI) has done so;
(c)
						developing emergency plans for dealing with accidental spills and personnel
						contamination, and investigating recombinant DNA activity laboratory
						accidents;
(d) providing advice on
						laboratory security;
(e) providing
						technical advice to the PI and IBC on recombinant DNA activity safety
						procedures.
See NIH Laboratory Safety Monograph for additional
							 information on the duties of the BSO.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 61 - Research › Subpart 61-1 - Recombinant Dna Research And Activity › Roles and Responsibilities › Section 61-1.33 - Principal investigator; responsibilities

Current through Register Vol. 46, No. 28, July 10, 2024
On behalf of the institution, the PI is responsible for
						  complying fully with this Subpart in conducting any recombinant DNA
						  activity.
(a) PI: general. As part of
						this general responsibility, the PI shall:
(1) initiate or modify no recombinant DNA
						activity requiring approval by the IBC prior to initiation (section
						61-1.20 
						of this Subpart: class III-A or III-B) until that activity, or the proposed
						modification thereof, has been approved by the institutional biosafety
						committee (IBC) and has met all other requirements of this Subpart;
(2) determine whether recombinant DNA
						activity is covered by section
						61-1.20 
						of this Subpart: class III-C;
(3)
						report within 30 days to the IBC and the commissioner all significant problems
						with and violations of this Subpart and all significant recombinant DNA
						activity-related accidents and illnesses;
(4) report to the IBC and to the commissioner
						new information bearing on provisions of this Subpart;
(5) be adequately trained in good
						microbiological techniques;
(6)
						adhere to IBC-approved emergency plans for dealing with accidental spills and
						personnel contamination; and
(7)
						comply with shipping requirements for recombinant DNA molecules.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 61 - Research › Subpart 61-1 - Recombinant Dna Research And Activity › Roles and Responsibilities › Section 61-1.34 - Personnel; training and qualifications

Current through Register Vol. 46, No. 28, July 10, 2024
The PI shall be responsible for providing instruction
						  and training in microbiological procedures and techniques to ensure safe work
						  conditions and awareness of procedures for dealing with accidents. Outlines for
						  imparting knowledge appropriate for recombinant DNA activity shall be provided
						  by the IBC consistent with recommendations made by NIH. Unless inconsistent
						  with such recommendations, all laboratory workers and other personnel with
						  duties in recombinant DNA activity facilities shall receive training to
						  include, as appropriate, the following:
(a) governmental and institutional
						requirements respecting biohazardous research;
(b) an explanation of the recombinant DNA
						activity engaged in, including organisms and degree of hazard;
(c) general safety measures, including
						required containment levels, use and disposal of protective clothing, handling
						techniques, disposal of wastes and decontamination of wastes, clothing and work
						surfaces;
(d) spill contamination
						notification procedures;
(e)
						identification of chemicals employed in the recombinant DNA activity and in
						decontamination, including possible hazards; and
(f) a description of health monitoring
						procedures, including frequency of physicals, nature of tests and symptoms, and
						filing and confidentiality of health records.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 61 - Research › Subpart 61-1 - Recombinant Dna Research And Activity › Roles and Responsibilities › Section 61-1.35 - Personnel; health monitoring programs

Current through Register Vol. 46, No. 28, July 10, 2024
The institution and the PI shall be responsible for
						  determining, in connection with each recombinant DNA activity, medical
						  surveillance of all personnel with duties in recombinant DNA activity
						  facilities before, during, and after their involvement in the activity,
						  including, as appropriate, a serum collection program, periodic examinations,
						  immunizations, reporting and investigating accidents and illnesses and medical
						  evaluation.
Note:
See NIH Laboratory Safety Monograph for further
						  details.
See NIH Laboratory Safety Monograph for further
							 details.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 61 - Research › Subpart 61-1 - Recombinant Dna Research And Activity › Roles and Responsibilities › Section 61-1.36 - Confidentiality of information

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
						Proprietary information submitted to NIH in connection with the approval
						procedures set forth in part VI, Voluntary Compliance, of the NIH Guidelines,
						as required for certification pursuan to subdivision (d) of section
						61-1.3 
						of this Subpart, will be protected by NIH as provided in part VI of the NIH
						Guidelines.
(b) Proprietary
						information submitted to the commissioner will be protected as follows:
(1) An institution may designate those items
						of information in applications, statements or reports to the commissioner or
						the department made pursuant to this Subpart, not protected by patent or
						copyright, which the institution believes are trade secrets or are maintained
						for the regulation of commercial enterprise which if disclosed would cause
						substantial injury to the competitive position of the subject
						enterprise.
(2) If the department
						receives a request under the Freedom of Information Law for information so
						designated, it will promptly contact the institution to secure its views as to
						whether the information (or some portion) should be released.
(3) If the department decides to release the
						information (or some portion) in response to a Freedom of Information Law
						request or otherwise, the institution will be advised, and the release will not
						be made until the expiration of 15 business days after receipt of the request,
						except to the extent that earlier release in the judgment of the commissioner
						is necessary to protect against an imminent hazard to the public or the
						environment.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 61 - Research › Subpart 61-1 - Recombinant Dna Research And Activity › Roles and Responsibilities › Section 61-1.37 - Complaints

Current through Register Vol. 46, No. 28, July 10, 2024
Information concerning noncompliance with a requirement
						  of this Subpart may be brought forward by any person. Copies of the complaint
						  shall be delivered to the institution concerned and to the commissioner. The
						  institution shall cause the complaint to be investigated and report the results
						  of its investigation and any action thereon promptly to the commissioner. Such
						  further action as the commissioner shall deem appropriate shall be taken by the
						  institution or the commissioner or both, including enforcement action
						  authorized under section 3223  of the Public Health Law and
						  withdrawal of approval of the institutional biosafety
						  committee.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter F - Disease Registry › Part 62 - Alzheimer's Disease And Related Disorders Registry › Section 62.1 - Filing of reports

Current through Register Vol. 46, No. 28, July 10, 2024
All cases or suspected cases of Alzheimer's disease and
					 related disorders shall be reported to the Commissioner of Health by
					 physicians, hospital administrators, laboratories, or persons in charge of the
					 State institutions, pathologists, coroners and medical examiners. Reports shall
					 be made in a manner and on forms prescribed by the commissioner. Penalties for
					 not reporting are provided in section 12  of the Public Health
					 Law.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter F - Disease Registry › Part 62 - Alzheimer's Disease And Related Disorders Registry › Section 62.2 - Confidentiality

Current through Register Vol. 46, No. 28, July 10, 2024
Reports of Alzheimer's disease and all related disorders
					 shall be kept confidential in accordance with Public Health Law, section
					 206.1(j).
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter F - Disease Registry › Part 62 - Alzheimer's Disease And Related Disorders Registry › Section 62.3 - Valid scientific research

Current through Register Vol. 46, No. 28, July 10, 2024
For the purposes of this Part, valid scientific
					 researchshall mean studies conducted for the purposes of etiological research,
					 discovering effective treatment of the disease, determining if there is a
					 genetic factor in disease occurrence, or other basic epidemiological research
					 activities. Research may be undertaken by any person licensed under title VIII
					 of the Education Law to perform diagnosis, treatment, medical services,
					 prescription or therapeutic exercises with regard to or upon human beings, or
					 any person deemed appropriately competent and qualified by a human research
					 review committee as provided by article 24-A of the Public Health
					 Law.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter F - Disease Registry › Part 62 - Alzheimer's Disease And Related Disorders Registry › Section 62.4 - Access to confidential file

Current through Register Vol. 46, No. 28, July 10, 2024
A confidential file of the reported Alzheimer's and related
					 disorders patients will be entered into a computer system. Persons seeking
					 access to the file for scientific research shall complete a form stating the
					 requester's name, affiliated organization and a narrative delineating research
					 purpose. The requester shall inform the Department of Health if he/she plans to
					 make patient contact as part of the research. The requester shall guarantee in
					 writing the confidentiality of all material reviewed from the Alzheimer's
					 disease registry, and any patient or family contacts. The Department of Health
					 will consult the requester's references and his/her supervisor. After the
					 aforesaid review, the commissioner shall determine whether to give the
					 requester access to the registry.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter G - Aids Testing, Communicable Diseases and Poisoning › Part 63 - Hiv/aids Testing, Reporting And Confidentiality Of Hiv-related Information › Section 63.2 - Application

Current through Register Vol. 46, No. 28, July 10, 2024
These regulations apply to physicians and other persons
					 authorized by law to order laboratory tests or to make medical diagnoses,
					 laboratories, blood banks, tissue banks and organ procurement organizations, to
					 persons who receive confidential HIV-related information in the course of
					 providing any health or social service and to persons who receive confidential
					 HIV-related information pursuant to a release. These regulations do not apply
					 to information which was received by the Commissioner under Subpart 24-1 of
					 this Title and protected from disclosure pursuant to Public Health Law section
					 206(1)(j). Insurance institutions, insurance support organizations, and health
					 care providers associated with or under contract to a health maintenance
					 organization or other medical services plan are subject to these
					 regulations.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter G - Aids Testing, Communicable Diseases and Poisoning › Part 63 - Hiv/aids Testing, Reporting And Confidentiality Of Hiv-related Information › Section 63.3 - Hiv-related testing

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
				  Except as noted in subdivision (c) of this section, no physician or other
				  person authorized pursuant to law may order an HIV-related test without first
				  having advise d the individual, or, when the individual lacks capacity to
				  consent, a person authorized to consent to health care for such individual,
				  that an HIV - related test will be performed . The physician, or other person
				  authorized pursuant to law, may not order the HIV - related test over the
				  objection of the individual, or person authorized to consent to health care
				  for such individual, except as authorized or required by law. A physician or
				  other person authorized pursuant to law to order an HIV-related test to be used
				  for the individual's care shall provide to the laboratory the name addresses,
				  and date of birth of the individual who is the source of the specimen and other
				  such information as specified by the Commissioner except in the case of
				  anonymous testing as provided for in this Part. Certification of consent does
				  not have to be provided to the laboratory.
(b) The advisement, and any objection to
				  testing, shall be noted in the individual 's medical record . Before ordering a
				  n HIV - related test, the physician or other person authorized by law to order
				  such test, or such person's representative, shall make the following
				  information available:
(1) HIV causes AIDS
				  and can be transmitted through sexual activities and by needle-sharing, by
				  pregnant women to their fetuses, and through breastfeeding infants;
(2) there is treatment for HIV that can help
				  an individual stay healthy;
(3)
				  individuals with HIV or AIDS can adopt safe practices to protect infected and
				  uninfected people in their lives from becoming infected or multiply infected
				  with HIV;
(4) testing is voluntary
				  and can be done anonymously at a public testing center;
(5) the law protects the confidentiality of
				  HIV-related test results;
(6) the
				  law prohibits discrimination based on an individual's HIV status and services
				  are available to help with such consequences; and
(7) the law requires that an individual be
				  advised before an HIV - related test is performed, and that no test shall be
				  performed over the individual's objection except as authorized or required by
				  law.
New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter G - Aids Testing, Communicable Diseases and Poisoning › Part 63 - Hiv/aids Testing, Reporting And Confidentiality Of Hiv-related Information › Section 63.4 - Filing of reports

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
(1) All determinations or diagnoses of Human
				  Immunodeficiency Virus (HIV) infection, HIV-related illness, and Acquired
				  Immune Deficiency Syndrome (AIDS) shall be reported to the commissioner by
				  physicians and other persons authorized to order diagnostic tests or make
				  medical diagnoses or their agents as soon as possible but no later than seven
				  (7) days after the provider's receipt of a positive laboratory result or after
				  diagnosis, whichever is sooner. Physicians and other persons authorized to
				  order diagnostic tests or make medical diagnoses, or their agents, shall report
				  to the commissioner any determination or diagnosis of acute HIV infection,
				  including primary HIV infection, acute retroviral syndrome, and early HIV
				  infection, within one day (24 hours) of such determination or diagnosis. Acute
				  HIV infection is the earliest stage of HIV disease, and it precedes the
				  development of detectable antibodies to HIV resulting from the viral infection.
				  A report of acute HIV infection must include the basis for the determination or
				  diagnosis, which is:
(i) laboratory testing
				  results demonstrating the presence of p24 antigen and HIV virus (RNA or DNA),
				  in the absence of HIV antibodies; and/or
(ii) clinical evidence of documented negative
				  testing history which includes previous negative or indeterminate test results
				  within 180 days before the first confirmed positive HIV test result of any
				  type.