Newborn Screening for Phenylketonuria and Other Diseases
NY-ADR
2/13/19 N.Y. St. Reg. HLT-31-18-00004-A
NEW YORK STATE REGISTER
VOLUME XLI, ISSUE 7
February 13, 2019
RULE MAKING ACTIVITIES
DEPARTMENT OF HEALTH
NOTICE OF ADOPTION
I.D No. HLT-31-18-00004-A
Filing No. 67
Filing Date. Jan. 28, 2019
Effective Date. Feb. 13, 2019
Newborn Screening for Phenylketonuria and Other Diseases
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
Amendment of Subpart 69-1 of Title 10 NYCRR.
Statutory authority:
Public Health Law, sections 2500-a and 2500-f
Subject:
Newborn Screening for Phenylketonuria and Other Diseases.
Purpose:
To support timely collection and submission of specimens for the detection of diseases in newborn infants in New York State.
Text or summary was published
in the August 1, 2018 issue of the Register, I.D. No. HLT-31-18-00004-P.
Final rule as compared with last published rule:
No changes.
Text of rule and any required statements and analyses may be obtained from:
Katherine Ceroalo, DOH, Bureau of Program Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, (518) 473-7488, email: [email protected]
Initial Review of Rule
As a rule that requires a RFA, RAFA or JIS, this rule will be initially reviewed in the calendar year 2022, which is no later than the 3rd year after the year in which this rule is being adopted.
Assessment of Public Comment
The Department of Health (“Department”) received comments from many members of the public, Greater New York Hospital Association, and New York City Department of Health & Mental Hygiene. Comments were received regarding the newborn screening panel, transportation of specimens, and the responsibilities of local health officers. These comments are summarized below along with the Department’s responses.
COMMENT: One commenter stated overall support of the regulation, but expressed concern about the use of the state contracted courier because of concerns among birth hospitals regarding delays in the transport of newborn screening specimens.
RESPONSE: The use of a specific overnight courier is awarded by State contract to ensure the Department receives newborn screening specimens in a timely manner. Comments related to the courier are outside the scope of the proposed regulatory amendments. No changes to the regulation are necessary as a result of this comment.
COMMENT: The New York City Department of Health and Mental Hygiene stated overall support of the regulation, but asked that the Department repeal Section 69-1.6 or amend the regulation to make the role of the local health officer at the New York City Department of Health and Mental Hygiene discretionary rather than mandatory.
RESPONSE: PHL §§ 2500-a and 2500-f authorize the State Commissioner of Health to promulgate regulations relating to newborn screening, including the manner in which testing, recording of test results, tracking, follow-up reviews and educational activities are conducted. Current regulations, promulgated pursuant to PHL §§ 2500-a and 2500-f, already require the local public health officer to take action to ensure that newborns receive newborn screening. Typically, such actions are only required if a repeat specimen is necessary and the Department and the hospital of birth have made multiple, unsuccessful attempts to locate the infant before the time the infant reaches six-weeks of age. The new regulations elaborate upon the existing requirements. No changes to the regulation were made as a result of this comment.
COMMENT: More than 40 commenters submitted comments in support of the regulatory amendments. These comments included positive statements about the inclusion of spinal muscular atrophy to the list of diseases to be screened for.
RESPONSE: The Department acknowledges these comments in support of the proposed regulation. No changes are necessary as a result of these comments.
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