[Federal Register Volume 68, Number 50 (Friday, March 14, 2003)]
[Rules and Regulations]
[Pages 12306-12308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5630]


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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.

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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: 
[email protected].

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