03-5630. 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.

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: [phone]; e-mail address: [e-mail].

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.

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:

☐ Hispanic or Latino

☐ Not Hispanic or Latino

Race (mark one or more):

☐ American Indian or Alaska Native

☐ Asian

☐ Black or African American

☐ Native Hawaiian or Other Pacific Islander

☐ 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.