[Federal Register: March 14, 2003 (Volume 68, Number 50)]
[Rules and Regulations]
[Page 12306-12308]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14mr03-7]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 50
Sterilization of Persons in Federally Assisted Family Planning
Projects
AGENCY: Department of Health and Human Services, Office of the
Secretary, Office of Public Health and Science, Office of Population
Affairs.
[[Page 12307]]
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: This final rule amends Public Health Service (PHS)
regulations, which govern the sterilization of persons in federally
assisted family planning projects, by making technical revisions to the
``Required Consent Form''.
DATES: This rule is effective March 14, 2003.
FOR FURTHER INFORMATION CONTACT: Evelyn Kappeler, Office of Population
Affairs, 4350 East West Highway, Suite 200, Bethesda, Maryland 20814;
telephone number: (301) 594-7608; e-mail address:
EKappeler@osophs.dhhs.gov.
SUPPLEMENTARY INFORMATION: On November 8, 1978, this Department
published in the Federal Register (43 FR 52146), final rules
prescribing the requirements for sterilizations funded under the
various health programs administered by the Department. Included with
the portion of the rules pertaining to those programs administered by
the PHS, as part of the appendix to subpart B, is a copy of the
required sterilization consent form. These rules, including the
appendix, have been codified at 42 CFR part 50, subpart B.
This final rule amends 42 CFR part 50 by revising the sterilization
consent form contained in the appendix to subpart B. These amendments
will make the codified PHS regulations conform with (1) recent
government-wide directives issued by the Office of Management and
Budget (OMB) concerning standards for maintaining, collecting and
presenting Federal data on race and ethnicity for all Federal reporting
purposes, and (2) the requirements under the Paperwork Reduction Act
(44 U.S.C. 3501 et seq.) regarding the respondent burden statement. In
order to effect a change in the materials codified in the Code of
Federal Regulations, however, the Department must issue these changes
in the form of a final rule.
Race and Ethnicity Data
Although not required, respondents to the sterilization consent
form are requested to supply information on their race and ethnicity.
The sterilization consent form contains information collections subject
to OMB approval under the Paperwork Reduction Act (PRA), and is being
revised to reflect more recent guidance on the appropriate racial and
ethnic information classifications.
After a comprehensive review process, including a notice and public
comment period, OMB revised its standards for the classification of
Federal Data on Race and Ethnicity (``Statistical Policy Directive No.
15, Race and Ethnic Standards for Federal Statistics and Administrative
Reporting''). The revised classification provides minimum standards for
maintaining, collecting and presenting data on race and ethnicity for
all Federal reporting purposes. The standards were developed to provide
a common language for uniformity and comparability in the collection
and use of data on race and ethnicity by Federal agencies. The
standards provide two formats that may be used for data on race and
ethnicity. Self-reporting and self-identification using two separate
questions is the OMB preferred method for collecting data on race and
ethnicity. To provide flexibility and ensure data quality, the OMB
directs that separate questions be used whenever feasible for reporting
race and ethnicity. Additionally, when race and ethnicity are collected
separately, ethnicity must be collected first. If race and ethnicity
are collected separately, OMB's minimum designations are as follows:
Ethnicity--Hispanic or Latino; Not Hispanic or Latino Race; Race--
American Indian or Alaska Native; Asian; Black or African American;
Native Hawaiian or Other Pacific Islander; White. Self-reporting or
self-identification using two separate questions is the OMB preferred
method for collecting data on race and ethnicity. The OMB standards
also state that respondents shall be offered the option of selecting
one or more racial designations. Consistent with these standards, this
final rule adopts the two-question format with an instruction to ``mark
one or more'' racial categories in the required sterilization consent
form.
Respondent Burden Statement
The sterilization consent form is also being amended to incorporate
the respondent burden statement, as required by the Paperwork Reduction
Act. This will ensure that each respondent receives, directly, a copy
of the required statement. Under the PRA, as well as the statute's
implementing regulations (5 CFR part 1320), the term ``burden'' means
the ``total time, effort, or financial resources'' the public expends
to provide information to or for a Federal agency, including reviewing
instructions; using technology to collect, process, and disclose
information; adjusting existing practices to comply with requirements;
searching data sources; completing and reviewing the collection of
information; and transmitting or disclosing information. Under the
Paperwork Reduction Act, agencies must take into account the burden
that their information collections impose on the public. This burden is
balanced with the ``practical utility'' of the information to be
collected. 44 U.S.C. 3502(2); 5 CFR 1320.3(b).
Justification for Omitting Notice of Proposed Rulemaking
Section 553(b)(B) of the Administrative Procedure Act (5 U.S.C.
553) provides that, when an agency for good cause finds that notice and
public procedures are impracticable, unnecessary or contrary to the
public interest, the agency may issue a rule without providing notice
and an opportunity for public comment. DHHS has determined that it is
unnecessary and impractical to follow proposed rulemaking procedures or
to delay the effective date of this regulation, since this amendment is
purely technical in nature, and simply amends the sterilization consent
form to conform with current OMB directives regarding the
classification of race and ethnicity data, which went through a notice
and comment period, as well as to reflect the statutory requirements of
the PRA.
Regulatory Assessment Requirements
This final rule implements technical amendments which have no
substantive impact on the underlying regulations, and it does not
otherwise impose or amend any requirements. As such, it is not a
``significant regulatory action'' subject to review by OMB under
Executive Order 12866, entitled Regulatory Planning and Review. This
final rule contains no new information collection or recordkeeping
requirements under the Paperwork Reduction Act (44 U.S.C. 3501 et
seq.). Furthermore, since the action does not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (5
U.S.C. 601 et seq.) do not apply. In addition, DHHS has determined that
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), and will not have a substantial
direct effect on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism. As there are no
Federalism implications, a Federalism impact statement is not required.
[[Page 12308]]
List of Subjects in 42 CFR Part 50
Drugs, Family planning, Grant programs-health, Healthcare,
Reporting and recordkeeping requirements, Sterilization.
Dated: January 30, 2003.
Alma L. Golden,
Deputy Assistant Secretary for Population Affairs.
Accordingly, in 42 CFR part 50, the appendix to subpart B,
``Required Consent Form,'' is amended as set forth below:
PART 50--POLICIES OF GENERAL APPLICABILITY
1. The authority citation for 42 CFR part 50 continues to read as
follows:
Authority: Sec. 215, Public Health Service Act, 58 Stat. 690 (42
U.S.C. 216); Sec. 1006, Public Health Service Act, 84 Stat. 1507 (42
U.S.C. 300a-4), unless otherwise noted.
Subpart B--Sterilization of Persons in Federally Assisted Family
Planning Projects
2. The appendix to subpart B is amended by:
(A) Under Consent to Sterilization, by removing the text regarding
race and ethnicity designation, which begins after the statement, ``You
are requested to supply the following information, but it is not
required:'' and adding the following text regarding race and ethnicity
designation in its place:
* * * * *
Ethnicity and Race Designation
Ethnicity:
[ballot] Hispanic or Latino
[ballot] Not Hispanic or Latino
Race (mark one or more):
[ballot] American Indian or Alaska Native
[ballot] Asian
[ballot] Black or African American
[ballot] Native Hawaiian or Other Pacific Islander
[ballot] White
* * * * *
(B) Adding the following statement to the end of the sterilization
consent form:
* * * * *
Paperwork Reduction Act Statement
A Federal agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it
displays the currently valid OMB control number. Public reporting
burden for this collection of information will vary; however, we
estimate an average of one hour per response, including for
reviewing instructions, gathering and maintaining the necessary
data, and disclosing the information. Send any comment regarding the
burden estimate or any other aspect of this collection of
information to the OS Reports Clearance Officer, ASBTF/Budget Room
503 HHH Building, 200 Independence Avenue, SW., Washington, DC
20201.
Respondents should be informed that the collection of
information requested on this form is authorized by 42 CFR part 50,
subpart B, relating to the sterilization of persons in federally
assisted public health programs. The purpose of requesting this
information is to ensure that individuals requesting sterilization
receive information regarding the risks, benefits and consequences,
and to assure the voluntary and informed consent of all persons
undergoing sterilization procedures in federally assisted public
health programs. Although not required, respondents are requested to
supply information on their race and ethnicity. Failure to provide
the other information requested on this consent form, and to sign
this consent form, may result in an inability to receive
sterilization procedures funded through federally assisted public
health programs.
All information as to personal facts and circumstances obtained
through this form will be held confidential, and not disclosed
without the individual's consent, pursuant to any applicable
confidentiality regulations.
[FR Doc. 03-5630 Filed 3-13-03; 8:45 am]
BILLING CODE 4150-34-P