5835 Federal Register / Vol. 68, No. 24 / Wednesday, February 5, 2003 / Rules and Regulations drawn westerly from the shoreline at position 36 ° ¥ 56.001  North latitude, 76 ° ¥ 19.726  West longitude to a point at 36 ° ¥ 55.996  North latitude, 76 ° ¥ 20.152  West longitude, thence southerly to a point at 36 ° ¥ 54.762  North latitude, 76 ° ¥ 20.244  West longitude, then southeasterly to a point at 36 ° ¥ 53.854  North latitude, 76 ° ¥ 20.093  West longitude, then to the shoreline at position 36 ° ¥ 54.216  North latitude, 76 ° ¥ 19.481  West longitude. ( b) Definitions: The designated representative of the Captain of the Port is any U. S. Coast Guard commissioned, warrant or petty officer who has been authorized by the Captain of the Port, Hampton Roads, Virginia to act on his behalf. ( 1) The Captain of the Port, Hampton Roads and the Command Duty Officer at the Marine Safety Office, Norfolk, Virginia can be contacted at telephone Number ( 757) 668   5555. ( 2) The Coast Guard vessels enforcing the security zone can be contacted on VHF   FM channels 13 and 16. ( c) Regulation: ( 1) In accordance with the general regulations in 165.33 of this part, entry into this zone is prohibited unless authorized by the Captain of the Port, Hampton Roads, Virginia, or his designated representatives. ( 2) The operator of any vessel in the immediate vicinity of this security zone shall: ( i) Stop the vessel immediately upon being directed to do so by any commissioned, warrant or petty officer on board a vessel displaying a U. S. Coast Guard Ensign. ( ii) Proceed as directed by any commissioned, warrant or petty officer on board a vessel displaying a U. S. Coast Guard Ensign. ( d) Effective date: This section is effective from 5 a. m. January 28, 2003 until 11: 59 p. m. February 4, 2003.

Dated: January 28, 2003. Lawrence M. Brooks, Captain, U. S. Coast Guard, Captain of the Port, Hampton Roads. [ FR Doc. 03   2695 Filed 2   4   03; 8: 45 am]

BILLING CODE 4910   15   P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2002   0308; FRL   7287   2]

6 Benzyladenine; Temporary Exemption From the Requirement of a Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes a temporary exemption from the requirement of a tolerance for residues of the biochemical pesticide 6 benzyladenine on apples and pistachios when applied/ used in accordance with the Experimental Use Permit 73049 EUP 2. Valent BioSciences Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act of 1996 ( FQPA), requesting the temporary tolerance exemption. This regulation eliminates the need to establish a maximum permissible level for residues of 6 benzyladenine. The temporary tolerance exemption will expire on January 31, 2005.

DATES: This regulation is effective February 5, 2003. Objections and requests for hearings, identified by docket ID number OPP   2002   0308, must be received by EPA on or before April 7, 2003. ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Denise Greenway, Biopesticides and Pollution Prevention Division ( 7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   8263; e mail address: greenway. denise@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:   Crop production ( NAICS 111)   Animal production ( NAICS 112)   Food manufacturing ( NAICS 311)   Pesticide manufacturing ( NAICS 32532)   Antimicrobial pesticides ( NAICS 32561) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2002   0308. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

II. Background and Statutory Findings In the Federal Register of March 28, 2002 ( 67 FR 14948) ( FRL   6828   9), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U. S. C. 346a, as amended by FQPA ( Public Law 104   170), announcing the filing of a pesticide tolerance petition ( PP 2G6378)

VerDate Dec< 13> 2002 20: 53 Feb 04, 2003 Jkt 200001 PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 05FER1. SGM 05FER1 5836 Federal Register / Vol. 68, No. 24 / Wednesday, February 5, 2003 / Rules and Regulations by Valent BioSciences Corporation, 870 Technology Way, Suite 100, Libertyville, IL 60048. This notice included a summary of the petition prepared by the petitioner Valent BioSciences Corporation. There were no comments received in response to the notice of filing. The petition requested that 40 CFR part 180 be amended to expand the existing tolerance exemption by establishing a temporary exemption from the requirement of a tolerance for residues of 6 benzyladenine. Section 408( c)( 2)( A)( i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance ( the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is `` safe.'' Section 408( c)( 2)( A)( ii) of the FFDCA defines `` safe'' to mean that `` there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408( b)( 2)( C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to `` ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....'' Additionally, section 408( b)( 2)( D) of the FFDCA requires that the Agency consider available information concerning the cumulative effects of a particular pesticide's residues and `` other substances that have a common mechanism of toxicity.'' EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

III. Toxicological Profile Consistent with section 408( b)( 2)( D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The toxicological profile for 6 benzyladenine has been previously published by the Agency in the N6 Benzyladenine ( synonymous with the subject active ingredient, 6 benzyladenine) Reregistration Eligibility Decision ( RED) document of June 1994 ( Ref. 1). The summarized values and categories for the various studies for the technical active ingredient are presented here. 1. Acute toxicity. Toxicity Category III was assigned to the acute oral toxicity study in the rat ( LD50 = 1.3 grams/ kilogram ( g/ kg)), and in the eye irritation study in the rabbit ( moderate irritant). Toxicity Category IV was assigned to the acute dermal toxicity study in the rabbit ( LD50 > 5 g/ kg), the acute inhalation toxicity study in the rat ( LC50 = 5.2 milligrams/ liter ( mg/ L)), and in the dermal irritation study in the rabbit ( slight irritant). Additionally, from a dermal sensitization study in the guinea pig, it was determined that N6 benzyladenine is not a dermal sensitizer. 2. Genotoxicity. From three mutagenicity studies ( Ames test, mouse micronucleus assay, and unscheduled DNA synthesis assay in the rat), it was determined that N6 benzyladenine is not mutagenic. 3. Developmental toxicity. The no observed adverse effect levels ( NOAEL) and the lowest observed adverse effect levels ( LOAEL) for maternal and developmental toxicity in rats, respectively, were found to be 50 and 175 mg/ kg of body weight ( bwt)/ day, respectively. 4. Subchronic toxicity. For rats of both sexes, the NOAEL was approximately 111 mg/ kg of bwt/ day and the LOAEL was approximately 304 mg/ kg of bwt/ day.

IV. Aggregate Exposures In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other nonoccupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings ( residential and other indoor uses).

A. Dietary Exposure 1. Food. Apple and pistachio field trials performed in support of the temporary tolerance exemption request and the associated experimental use permit yielded acceptable magnitude of the residue data ( Ref. 2). Residues were below the limit of quantitation ( LOQ) for pistachios treated with a total of 60 g of active ingredient ( a. i.) per acre. In apples, residues of 6 benzyladenine were consistently near the LOQ. However, residues did not increase in processed commodities ( relative to the levels on the raw commodity), and were below the LOQ. Thus, the apple field data are adequate to support the temporary tolerance exemption petition and experimental program to apply   182 grams of active ingredient per acre per season. Also, because application precedes harvest by 2 months for pistachio and by approximately 2.5 months for apple, the potential for dietary exposure is reduced. Due to the low anticipated dietary intake of 6 benzyladenine residues relative to the chronic and acute population adjusted doses ( see Unit VI, below), and the fact that actual exposure will probably be considerably less because the dietary exposure analysis was based on worst case assumptions, it is highly unlikely that the proposed new uses of 6 benzyladenine on apples and pistachios will result in adverse effects to human health. 2. Drinking water exposure. The proposed uses on apples and pistachios are not expected to add potential exposure to drinking water. Soil leaching studies have suggested that 6 benzyladenine is relatively immobile ( Ref. 3), absorbing to sediment. Residues reaching surface waters from field runoff should quickly absorb to sediment particles and be partitioned from the water column. 6 Benzyladenine also has low solubility in water, 76 ± 2 mg/ L at 20 ° C ( Ref. 2), and detections in ground water are not expected. Together, these data indicate that residues are not expected in drinking water.

B. Other Non Occupational Exposure The potential for non dietary exposure to 6 benzyladenine residues for the general population, including infants and children, is unlikely because the uses are limited to experimental applications in apple and pistachio orchards. Because 6 benzyladenine is a naturally occurring cytokinin plant regulator ( Ref. 4, 5, 6, 7, and 8), it is a normal part of the human diet. The proposed experimental use rates are well below the toxicity NOAELs. The residues indicate dietary exposures that are 0.03% and 0.01% of the chronic and acute population adjusted doses, respectively. Therefore, while there exists a great likelihood of prior exposure for most, if not all, individuals to 6 benzyladenine, any increased exposure due to the proposed VerDate Dec< 13> 2002 20: 53 Feb 04, 2003 Jkt 200001 PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 05FER1. SGM 05FER1 5837 Federal Register / Vol. 68, No. 24 / Wednesday, February 5, 2003 / Rules and Regulations experimental product would be negligible due to the lack of residue in comparison with the toxicity NOAELs.

V. Cumulative Effects The Agency has considered the cumulative effects of 6 benzyladenine and other substances in relation to a common mechanism of toxicity. These considerations include the possible cumulative effects of such residues on infants and children. Based on the available information and data for 6 benzyladenine, no mammalian toxicity is expected at the proposed experimental use rates. Therefore, no cumulative effects are expected.

VI. Determination of Safety for U. S. Population, Infants and Children 1. U. S. population. The analysis estimated that the chronic exposures for the overall U. S. population was 0.000014 mg/ kg/ day ( 0.03% of the chronic population adjusted dose ( cPAD)). The acute dietary estimated exposure was 0.000069 mg/ kg/ day ( 0.01% of the acute population adjusted dose ( aPAD)) for the overall U. S. population. Critical exposure commodity analysis showed that apple juice contributed the most to dietary exposure for the overall population. Due to the low anticipated dietary intake of 6 benzyladenine residues relative to the chronic and acute population adjusted doses, and the fact that actual exposure will probably be considerably less because the dietary exposure analysis was made based on worst case assumptions, it is likely that the proposed new uses of 6 benzyladenine on apples and pistachios will not result in adverse effects to human health. 2. Infants and children. The analysis estimated that the chronic exposures for the most highly exposed subgroup, nonnursing infants, was 0.000085 mg/ kg/ day ( 0.2% of the cPAD). The acute dietary estimated exposure was 0.000361 mg/ kg/ day ( 0.07% of aPAD) for the most highly exposed subgroup, non nursing infants. Critical exposure commodity analysis showed that apple juice contributed the most to dietary exposure for all infants. Due to the low anticipated dietary intake of 6 benzyladenine residues relative to the chronic and acute PAD, and the fact that actual exposure will probably be considerably less because the dietary exposure analysis was made based on worst case assumptions, it is likely that the proposed new uses of 6 benzyladenine on apples and pistachios will not result in adverse effects to human health. VII. Other Considerations A. Endocrine Disruptors EPA is required under the FFDCA as amended by FQPA to develop a screening program to determine whether certain substances ( including all pesticide active and other ingredients) `` may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.'' Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee ( EDSTAC), EPA determined that there is no scientific basis for including, as part of the program, the androgen and thyroid hormone systems in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program ( EDSP). When the appropriate screening and/ or testing protocols being considered under the Agency's EDSP have been developed, 6 benzyladenine may be subjected to additional screening and/ or testing to better characterize effects related to endocrine disruption. Based on available data, no endocrine system related effects have been identified with consumption of 6 benzyladenine. To date, there is no evidence to suggest that 6 benzyladenine affects the immune system, functions in a manner similar to any known hormone, or that it acts as an endocrine disruptor.

B. Analytical Method The Agency is establishing a temporary exemption from the requirement of a tolerance for the reasons stated above. For the same reasons, the Agency has concluded that an analytical method is not required for enforcement purposes for 6 benzyladenine.

C. Codex Maximum Residue Level Currently, there are no Codex, Canadian or Mexican maximum residue levels for residues of 6 benzyladenine in/ on apples or pistachios. VIII. Conclusions Based on the toxicology information submitted and reviewed previously, and summarized in the June 1994 N6 Benzyladenine RED ( Ref. 1), there is a reasonable certainty that no harm will result from aggregate exposure of residues of 6 benzyladenine to the U. S. population, including infants and children, under reasonably foreseeable circumstances, when the biochemical pesticide is used in accordance with good agricultural practices under the conditions of the 2   year experimental program. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion based on the data submitted previously and summarized in the RED, as well as that data submitted to support the temporary tolerance exemption and Experimental Use Permit applications, demonstrating negligible dietary exposure in comparison with the toxicity NOAELs. As a result, EPA establishes a temporary exemption from the tolerance requirements pursuant to FFDCA 408( c) and ( d) for residues of 6 benzyladenine in or on apples and pistachios.

IX. Objections and Hearing Requests Under section 408( g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) of the FFDCA provides essentially the same process for persons to `` object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d), as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP   2002   0308 in the subject line on the first page of your submission. All VerDate Dec< 13> 2002 20: 53 Feb 04, 2003 Jkt 200001 PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 05FER1. SGM 05FER1 5838 Federal Register / Vol. 68, No. 24 / Wednesday, February 5, 2003 / Rules and Regulations requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before April 7, 2003. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 703) 603   0061. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305   5697, by e mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VIII. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 1. Mail your copies, identified by docket ID number OPP   2002   0308, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 1. You may also send an electronic copy of your request via e mail to: oppdocket epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested ( 40 CFR 178.32).

X. References 1. U. S. EPA, Reregistration Eligibility Decision ( RED) N6 Benzyladenine, June 1994. 2. U. S. EPA; Memorandum; R. S. Jones to D. Greenway; October 2, 2002. 3. Weigand, R., et al, Metabolism and Movement of N[ Phenylmethyl] 1HPurin 6 Amine in Soils, 1976. Unpublished study received January 13, 1977 for EPA Registration Number 275 32; submitted by Abbott Laboratories, North Chicago, IL; CDL: 095728 C. 4. Nandi, S. K., et al, Identification of cytokinins in primary crown gall tumours of tomato, Plant Cell and Environment ( 1989) 12: 273 283. 5. Pechova, D., et al, Identification of new aromatic cytokinins in plants, 17th International Conference on Plant Growth Substances, July 1 6, 2001. 6. Strnad, M., et al, Immunodectection and identification of N6( o hydroxybenzylamino) purine as a naturally occurring cytokinin in Populus x canadensis Moench cv Robusta leaves, Plant Physiol. ( 1992) 99: 74 80. 7. Strnad, M., Enzyme immunoassays of N6 benzyladenine and N6( metahydroxybenzyl adenine cytokinins, J Plant Growth Regul. ( 1996) 15: 179 188. 8. Van Staden, J. and N. R. Crouch, Benzyladenine and derivatives their significance and interconversion in plants, Plant Growth Regulation ( 1996) 19: 153 175.

XI. Statuatory and Executive Order Review This final rule establishes an exemption from the tolerance requirement under section 408( d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget ( OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104   4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104   113, section VerDate Dec< 13> 2002 20: 53 Feb 04, 2003 Jkt 200001 PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 05FER1. SGM 05FER1 5839 Federal Register / Vol. 68, No. 24 / Wednesday, February 5, 2003 / Rules and Regulations 12( d) ( 15 U. S. C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408( d) of the FFDCA, such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on 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( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects 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.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408( n)( 4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

XII. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule '' as defined by 5 U. S. C. 804( 2).

List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: January 16, 2003. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180   [ AMENDED]

1. The authority citation for part 180 continues to read as follows:

Authority: 21 U. S. C. 321( q), 346( a) and 374.

2. Section 180.1150 of subpart D is revised to read as follows:

§ 180.1150 6 Benzyladenine; exemption from the requirement of a tolerance.

( a) The plant growth regulator 6 benzyladenine is exempt from the requirement of a tolerance when used as a fruit thinning agent at an application rate not to exceed 30 grams of active ingredient per acre in or on apples. ( b) 6 Benzyladenine is temporarily exempt from the requirement of a tolerance in or on apples at   182 grams of active ingredient per acre per season, and in or on pistachio at   60 grams of active ingredient per acre per season when used in accordance with the Experimental Use Permit 73049   EUP   2. The temporary exemption from a tolerance will expire on January 31, 2005. [ FR Doc. 03   2431 Filed 2   4   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2002   0344; FRL   7289   7]

Cyprodinil; Pesticide Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes tolerances for residues of cyprodinil in or on the bushberry subgroup, caneberry subgroup, juneberry, lingonberry, pistachio, salal and watercress. The Interregional Research Project Number 4 ( IR 4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act ( FFDCA) , as amended by the Food Quality Protection Act of 1996 ( FQPA). DATES: This regulation is effective February 5, 2003. Objections and requests for hearings, identified by docket ID number OPP   2002   0344, must be received on or before April 7, 2003. ADDRESSES: Written objections and hearing requests may besubmitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Hoyt Jamerson, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   9368; e mail address: jamerson. hoyt@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:   Crop production ( NAICS Code 111)   Animal production ( NAICS Code 112)   Food manufacturing ( NAICS Code 311)   Pesticide manufacturing ( NAICS Code 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be VerDate Dec< 13> 2002 20: 53 Feb 04, 2003 Jkt 200001 PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 05FER1. SGM 05FER1


[Federal Register Volume 80, Number 112 (Thursday, June 11, 2015)]
[Notices]
[Pages 33334-33336]
[FR Doc No: 2015-14255]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2014-0125; Notice 1]

General Motors, LLC, Receipt of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Receipt of petition.

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SUMMARY: General Motors, LLC, (GM) has determined that certain model
year (MY) 2015 GMC multipurpose passenger vehicles (MPV) do not fully
comply with paragraph S7.8.5 of Federal Motor Vehicle Safety Standard
(FMVSS) No. 108, Lamps, Reflective Devices and Associated Equipment. GM
has filed an appropriate report dated November 5, 2014, pursuant to 49
CFR part 573, Defect and Noncompliance Responsibility and Reports.

DATES: The closing date for comments on the petition is July 13, 2015.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited at the beginning of this notice and
submitted by any of the following methods:
     Mail: Send comments by mail addressed to: U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
     Hand Deliver: Deliver comments by hand to: U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. The
Docket Section is open on weekdays from 10 a.m. to 5 p.m. except
Federal Holidays.
     Electronically: Submit comments electronically by: logging
onto the Federal Docket Management System (FDMS) Web site at http://www.regulations.gov/. Follow the online instructions for submitting
comments. Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that your comments were received, please
enclose a stamped, self-addressed postcard with the comments. Note that
all comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
    Documents submitted to a docket may be viewed by anyone at the
address and times given above. The documents may also be viewed on the
Internet at http://www.regulations.gov by following the online
instructions for accessing the dockets. DOT's complete Privacy Act
Statement is available for review in the Federal Register published on
April 11, 2000, (65 FR 19477-78).
    The petition, supporting materials, and all comments received
before the close of business on the closing date indicated below will
be filed and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the extent possible. When the petition is granted or
denied, notice of the decision will be published in the Federal
Register pursuant to the authority indicated below.

SUPPLEMENTARY INFORMATION:
    I. GM's Petition: Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see
implementing rule at 49 CFR part 556), GM submitted a petition for an
exemption from the notification and remedy requirements of 49 U.S.C.
Chapter 301 on the basis that this noncompliance is inconsequential to
motor vehicle safety.
    This notice of receipt of GM's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.
    II. Vehicles Involved: Affected are approximately 51,616 MY 2015
GMC Yukon, Yukon Denali, Yukon XL, and Yukon XL Denali MPVs
manufactured between September 19, 2013 and October 10, 2014. See GM's
petition for additional details.
    III. Noncompliance: GM explains that the noncompliance is that
under certain conditions the parking lamps on the subject vehicles fail
to meet the device activation requirements of paragraph S7.8.5 of FMVSS
No. 108.
    IV. Rule Text: Paragraph S7.8.5 of FMVSS No. 108, as detailed in
Table I-a, requires in pertinent part that the activation of parking
lamps must be ``Steady burning. Must be activated when the headlamps
are activated in a steady burning state.''
    V. Summary of GM's Analyses: GM stated its belief that the subject
noncompliance is inconsequential to motor vehicle safety for the
following reasons:
    (A) GM explains that the condition is difficult to create even in
laboratory settings, let alone real-world driving conditions. GM also
stated that they were only able to duplicate the condition under the
following circumstances:
     The vehicle is being operated during the daytime with the
master lighting switch in ``AUTO'' mode.
     The transmission is not in ``Park.''
     Three or more high-inrush current spikes that exceed the
body control module (BCM) inrush current threshold occur on the parking
lamp/DRL circuit within a period of 0.625 seconds. While there may be
other methods for triggering these spikes (e.g., a service event), GM
has only been able to isolate one cause: Manually moving the master
lighting control from ``AUTO'' to parking lamp (or headlamp), back to
``AUTO'' and back to parking lamp (or headlamp) within 0.625 seconds.
    (B) GM believes that drivers are unlikely to cause these spikes
during real-world driving. The subject vehicles are equipped with
automatic-headlamp operation, so there is very little need for drivers
to ever manually operate their vehicle's master lighting control. But
even if a driver were inclined to do so, rapidly cycling a vehicle's
master lighting control from ``AUTO'' to parking lamp (or headlamp)
back to ``AUTO'' and back to parking lamp (or headlamp) in less than a
second is a highly unusual maneuver that few (if any) drivers would
ever attempt during normal vehicle operation.
    (C) GM additionally explained that the condition is short-lived and
that if the condition does occur any of the following routine
operations will automatically correct the condition:
     Cycling the vehicle's ignition on and off with the master
lighting control in auto mode.
     Turning the ignition off with the master lighting control
in any mode other than auto, and then turning the ignition back on
after a minimum of ten minutes.
     Cycling the master lighting control to off and then back
to any on position.
     If the vehicle is in DRL mode, activating both turn
signals, or shifting the transmission in and out of ``PARK.''
    (D) GM mentions that while the condition affects the parking lamps
and DRL's it does not affect the operation of the vehicle's other
lamps.
    (E) GM also cited a previous petition that NHTSA granted dealing
with a noncompliance that GM believes is similar to the noncompliance
that is the subject of its petition.
    GM is not aware of any field incidents or warranty claims relating
to the subject noncompliance.
    GM has additionally informed NHTSA that it corrected the
noncompliance in subsequent production of the subject vehicles.
    In summation, GM believes that the described noncompliance of the
subject vehicles is inconsequential to motor vehicle safety, and that
its petition, to exempt GM from providing recall notification of
noncompliance as required by 49 U.S.C. 30118 and remedying the recall
noncompliance as required by 49 U.S.C. 30120 should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject vehicles that GM no longer

controlled at the time it determined that the noncompliance existed.
However, any decision on this petition does not relieve vehicle
distributors and dealers of the prohibitions on the sale, offer for
sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant vehicles under their control after GM
notified them that the subject noncompliance existed.

    Authority: (49 U.S.C. 30118, 30120: Delegations of authority at
49 CFR 1.95 and 501.8).

Jeffrey Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2015-14255 Filed 6-10-15; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register: June 19, 2008 (Volume 73, Number 119)]
[Rules and Regulations]
[Page 34847-34849]
[DOCID:fr19jn08-3]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0275; Directorate Identifier 2007-NM-335-AD;
Amendment 39-15565; AD 2008-13-02]
RIN 2120-AA64

Airworthiness Directives; BAE Systems (Operations) Limited
(Jetstream) Model 4101 Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    Cracks have been found in the propeller blades and propeller
hubs, for which ongoing controlling actions issued by the propeller
TC [type certificate] holder (McCauley Propeller Systems) have been
mandated by FAA Airworthiness Directive (AD) action.
    Current FAA ADs related to this subject are 2003-17-10 (which
superseded AD 2003-15-01), 2004-23-16, 2005-24-08 and 2006-15-13.
    Cracking of the blade or hub can ultimately lead to blade
release with potentially catastrophic consequences. * * *

* * * * *
    We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective July 24, 2008.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of July 24,
2008.

ADDRESSES: You may examine the AD docket on the Internet at http://
www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Todd Thompson, Aerospace Engineer,
International Branch, ANM-116, FAA, Transport Airplane Directorate,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1175; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on March 13, 2008 (73
FR 13504). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    Cracks have been found in the propeller blades and propeller
hubs, for which ongoing controlling actions issued by the propeller
TC [type certificate] holder (McCauley Propeller Systems) have been
mandated by FAA Airworthiness Directive (AD) action.
    Current FAA ADs related to this subject are 2003-17-10 (which
superseded AD 2003-15-01), 2004-23-16, 2005-24-08 and 2006-15-13.
    Cracking of the blade or hub can ultimately lead to blade
release with potentially catastrophic consequences. BAE Systems has
concluded that safety margins can be further improved by introducing
operating limitations that will prevent damaging stresses in the
propeller assembly, instructing flight crews to place the propeller
condition levers in the Flight position during all ground
maneuvering.
    EASA concurs with this conclusion and this AD therefore requires
the replacement of the Propeller Limitations Placard with a new one.

    Corrective actions include revising the airplane flight manual. You
may obtain further information by examining the MCAI in the AD docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a NOTE within the AD.

Costs of Compliance

    We estimate that this AD will affect about 7 products of U.S.
registry. We also estimate that it will take about 2 work-hours per
product to comply with the basic requirements of this AD. The average
labor rate is $80 per work-hour. Required parts will cost about $25 per
product. Where the service information lists required parts costs that
are covered under warranty, we have assumed that there will be no
charge for these parts. As we do not control warranty coverage for
affected parties, some parties may incur costs higher than estimated
here. Based on these figures, we estimate the cost of this AD to the
U.S. operators to be $1,295, or $185 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD 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.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2008-13-02 BAE Systems (Operations) Limited (Formerly British
Aerospace Regional Aircraft): Amendment 39-15565. Docket No. FAA-
2008-0275; Directorate Identifier 2007-NM-335-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective July 24,
2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to BAE Systems (Operations) Limited
(Jetstream) Model 4101 airplanes, all serial numbers, certificated
in any category.

Subject

    (d) Air Transport Association (ATA) of America Code 11: Placards
and Markings.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    Cracks have been found in the propeller blades and propeller
hubs, for which ongoing controlling actions issued by the propeller
TC [type certificate] holder (McCauley Propeller Systems) have been
mandated by FAA Airworthiness Directive (AD) action.

    Current FAA ADs related to this subject are 2003-17-10 (which
superseded AD 2003-15-01), 2004-23-16, 2005-24-08 and 2006-15-13.
    Cracking of the blade or hub can ultimately lead to blade
release with potentially catastrophic consequences. BAE Systems has
concluded that safety margins can be further improved by introducing
operating limitations that will prevent damaging stresses in the
propeller assembly, instructing flight crews to place the propeller
condition levers in the Flight position during all ground
maneuvering.
    EASA concurs with this conclusion and this AD therefore requires
the replacement of the Propeller Limitations Placard with a new one.
    Corrective actions include revising the airplane flight manual.

Actions and Compliance

    (f) Within 90 days after the effective date of this AD, unless
already done, do the following actions.
    (1) Replace the existing Propeller Limitations Placard in the
cockpit with a new placard, in accordance with the Accomplishment
Instructions of BAE Systems (Operations) Limited Service Bulletin
J41-11-027, dated March 29, 2007.
    (2) Revise the BAe Jetstream Series 4100 Flight Manual (FM) to
include the information in BAe Jetstream Series 4100 General
Amendment G12, approved January 2007, and BAe Jetstream Series 4100
Advance Amendment Bulletin 13, approved April 4, 2007. General
Amendment G12 describes a rolling take-off technique and the reduced
possibility of landing with ice contaminating the wings, and adds a
Gross Height/Pressure Altitude Conversion Chart. Advance Amendment
Bulletin 13 introduces procedures for placing the propeller
condition levers in the Flight position during all ground
maneuvering. Operate the airplane according to the procedures in
General Amendment G12 and Advance Amendment Bulletin 13.

    Note 1: This may be done by inserting copies of General
Amendment G12 and Advance Amendment Bulletin 13 into the FM. When
General Amendment G12 and Advance Amendment Bulletin 13 have been
included in general revisions of the FM, the general revisions may
be inserted in the FM, provided the relevant information in the
general revision is identical to that in General Amendment G12 and
Advance Amendment Bulletin 13.

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN: Todd
Thompson, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency (EASA)
Airworthiness Directive 2007-0268, dated October 8, 2007; BAE
Systems (Operations) Limited Service Bulletin J41-11-027, dated
March 29, 2007; BAe Jetstream Series 4100 General Amendment G12,
approved January 2007, to the Jetstream Series 4100 Flight Manual;
and BAe Jetstream Series 4100 Advance Amendment Bulletin 13,
approved April 4, 2007, to the Jetstream Series 4100 Flight Manual;
for related information.

Material Incorporated by Reference

    (i) You must use the service information specified in Table 1 of
this AD to do the actions required by this AD, as applicable, unless
the AD specifies otherwise. (The approval date of BAe Jetstream
Series 4100 General Amendment G12 is specified only on page 0-2-4.)
BAe Jetstream Series 4100 General Amendment G12 contains the
following effective pages:

Page

    List of Effective Pages
    Pages 0-4-1 through 0-4-6

Date

    January 2007

              Table 1.--Material Incorporated by Reference
------------------------------------------------------------------------
               Service information                         Date
------------------------------------------------------------------------
BAe Jetstream Series 4100 Advance Amendment       April 4, 2007.
 Bulletin 13 to the Jetstream Series 4100 Flight
 Manual.
BAe Jetstream Series 4100 General Amendment G12   January, 2007.
 to the Jetstream Series 4100 Flight Manual.
BAE Systems (Operations) Limited Service          March 29, 2007.
 Bulletin J41-11-027.
------------------------------------------------------------------------

    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
British Aerospace Regional Aircraft American Support, 13850 Mclearen
Road, Herndon, Virginia 20171.
    (3) You may review copies at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>,
or go to: http://www.archives.gov/federal-register/cfr/ibr-
locations.html.

    Issued in Renton, Washington, on June 10, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E8-13563 Filed 6-18-08; 8:45 am]

BILLING CODE 4910-13-P


International Symposium on Grain Elevator Explosions.

July 11-12, 1978. Volume 1 - Preprints

This document has a large volume of  material; 447 pages.

A copy is available for viewing in the OSHA Docket Office/Technical Data
Center, FPB, 200 Constitution Avenue, Rm. N2625, Washington, DC 20210


[Federal Register Volume 79, Number 130 (Tuesday, July 8, 2014)]
[Rules and Regulations]
[Pages 38462-38464]
[FR Doc No: 2014-15931]

-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2014-0522]
RIN 1625-AA00

Safety Zone, Metedeconk River; Brick Township, NJ

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is temporarily changing the enforcement date
of a safety zone for one recurring fireworks display in the Fifth Coast
Guard District. This regulation applies to only one recurring fireworks
event held in the waters of Metedeconk River in Brick Township, NJ.
Instead of the usual enforcement periods--July 4, every Thursday in
August, and the first Thursday in September--in 2014 enforcement will
take place on July 3, July 17, and August 14. The safety zone is
necessary to provide for the safety of life on navigable waters during
the event. This action is intended to restrict vessel traffic in a
portion of Metedeconk River near Brick Township, NJ, during the event.

DATES: This rule is effective from July 8, 2014 through August 14, 2014
and will be enforced from 8:30 p.m. to 10:00 p.m. on July 3, July 17,
and August 14, 2014.

ADDRESSES: Submit comments using one of the listed methods, and see
SUPPLEMENTARY INFORMATION for more information on public comments.
     Online--http://www.regulations.gov following Web site
instructions.
     Fax--202-493-2251.
     Mail or hand deliver--Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001. Hours
for hand delivery are 9 a.m. to 5 p.m., Monday through Friday, except
Federal holidays (telephone<PHONE_NUMBER>).

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Brennan Dougherty, U.S. Coast Guard, Sector
Delaware Bay, Chief Waterways Management Division, Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If you
have questions on viewing or submitting material to the docket, call
Cheryl Collins, Program Manager, Docket Operations, telephone (202)
366-9826.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The governing regulation for this fireworks display event is 33 CFR
165.506. The specifics for this event are listed in the Table to Sec.
165.506, section (a), item 9.
    We are issuing this final rule without prior notice and opportunity
to comment, and to take effect less than 30 days after publication in
the Federal Register, pursuant to the Administrative Procedure Act
(APA), 5 U.S.C. 553(b) and (d)(3), which authorize an agency to issue a
rule without following usual APA procedures when the agency for good
cause finds that those procedures are ``impracticable, unnecessary, or
contrary to the public interest.'' We find that good cause exists for
not following usual procedures because to do so would delay issuance of
this rule beyond some of the dates for which it is intended, thereby
exposing mariners and the public to dangers associated with fireworks
displays, contrary to the public interest in safety.

B. Basis and Purpose

    The legal basis of this rule is found in 33 U.S.C. 1231; 46 U.S.C.
Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Public Law 107-295, 116 Stat. 2064; and Department
of Homeland Security Delegation No. 0170.1. The purpose of this rule is
to promote public and maritime safety during a fireworks display.

C. Discussion of the Final Rule

    We are temporarily changing the enforcement periods for Brick
Township safety zone, to reflect that in 2014 fireworks will be held on
July 3, July 17, and August 14. This change is needed to accommodate
the sponsor's event plan. No other portion of the Table to Sec.
165.506 or other provisions in Sec.  165.506 is affected by this
regulation.
    The regulated area of this safety zone includes all the waters of
the Metedeconk River within a 500 yard radius of the fireworks launch
platform in approximate position latitude 40[deg]03'24'' N, longitude
074[deg]06'42'' W, near the shoreline at Brick Township, NJ.
    During the period of the safety zone, all persons and vessels will
be prohibited from entering, transiting, mooring, or remaining within
the zone, unless specifically authorized by the Captain of the Port
Delaware Bay, or her designated representative. Those persons
authorized to transit through the safety zone shall abide by and follow
all directions provided by the Captain of the Port Delaware Bay, or her
designated representative, in order to ensure they are not disrupting
the fireworks display. U.S. Coast Guard Sector Delaware Bay will notify
the public by broadcast notice to mariners at least one hour prior to
the times of enforcement.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes or executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. Although this regulation
will restrict access to the regulated area, the effect of this rule
will not be significant because: (i) The Coast Guard will make
extensive notification of the Safety Zone to the maritime public via
maritime advisories so mariners can alter their plans accordingly; (ii)
vessels may still be permitted to transit through the safety zone with
the permission of the Captain of the Port on a case-by-case basis; and
(iii) this rule will be enforced for only the duration of the fireworks
display.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities. This rule will affect the following entities, some of
which may be small entities: The owners or operators of vessels
intending to anchor or transit along a portion of the Metedeconk River
near Brick Township, New Jersey from 8:30 p.m. to 10:00 p.m. on July 3,
July 17, and August 14, 2014, unless cancelled earlier by the Captain
of the Port once all operations are completed.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reason: Vessel
traffic will be allowed to pass through the zone with permission of the
Coast Guard Captain of the Port Delaware Bay or her designated
representative and zone is limited in size and duration. Sector
Delaware Bay will issue maritime advisories widely available to users
of the Delaware Bay and River.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves implementation of regulations within 33
CFR Part 165, applicable to safety zones on the navigable waterways.
This zone will temporarily restrict vessel traffic from transiting the
waters of the Metedeconk River along the shoreline of Brick Township,
NJ, in order to protect the safety of life and property on the waters
for the duration of the fireworks display. This rule is categorically
excluded from further review under paragraph 34(g) of Figure 2-1 of the
Commandant Instruction. An environmental analysis checklist supporting
this determination and a Categorical Exclusion Determination are
available in the docket where indicated under ADDRESSES. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping

requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-
295, 116 Stat. 2064; Department of Homeland Security Delegation No.
0170.1.

0
2. Add temporary Sec.  165.T05-0522, to read as follows:

Sec.  165.T05-0522  Safety Zone, Metedeconk River; Brick Township, NJ.

    (a) Location. The regulated area of this safety zone includes all
the waters of the Metedeconk River within a 500 yard radius of the
fireworks launch platform in approximate position latitude
40[deg]03'24'' N, longitude 074[deg]06'42'' W, near the shoreline at
Brick Township, NJ.
    (b) Enforcement period. This rule will be enforced from 8:30 p.m.
to 10:00 p.m. on July 3, July 17, and August 14, 2014, unless cancelled
earlier by the Captain of the Port once all operations are completed.
    (c) Regulations. All persons are required to comply with the
general regulations governing safety zones in 33 CFR 165.33.
    (1) All persons or vessels wishing to transit through the Safety
Zone must request authorization to do so from the Captain of the Port
or her designated representative one hour prior to the intended time of
transit.
    (2) Vessels granted permission to transit must do so in accordance
with the directions provided by the Captain of the Port or her
designated representative to the vessel.
    (3) To seek permission to transit the Safety Zone, the Captain of
the Port's representative can be contacted via marine radio VHF Channel
16.
    (4) This section applies to all vessels wishing to transit through
the Safety Zone except vessels that are engaged in the following
operations:
    (i) Enforcing laws;
    (ii) Servicing aids to navigation, and
    (iii) Emergency response vessels.
    (5) No person or vessel may enter or remain in a safety zone
without the permission of the Captain of the Port;
    (6) Each person and vessel in a safety zone shall obey any
direction or order of the Captain of the Port;
    (7) No person may board, or take or place any article or thing on
board, any vessel in a safety zone without the permission of the
Captain of the Port; and
    (8) No person may take or place any article or thing upon any
waterfront facility in a safety zone without the permission of the
Captain of the Port.
    (d) Definitions.
    (1) The Captain of the Port means the Commander of Sector Delaware
Bay or any Coast Guard commissioned, warrant, or petty officer who has
been authorized by the Captain of the Port to act on her behalf.
    (e) Enforcement. The U.S. Coast Guard may be assisted in the patrol
and enforcement of the Safety Zone by Federal, State, and local
agencies.

0
3. At Sec.  165.506, in the Table to Sec.  165.506, make the following
amendments:
0
a. Under section (a). Coast Guard Sector Delaware Bay--COTP Zone,
suspend entry ``9''.
0
b. Under, section (a). Coast Guard Sector Delaware Bay--COTP Zone, add
entry ``17'', which will be enforced from 8:30 p.m. until 10 p.m. on
July 3, July 17, and August 14, 2014, to read as follows:

Sec.  165.506  Safety Zones; Fireworks Displays in the Fifth Coast
Guard District.

* * * * *

                                             Table to Sec.   165.506
----------------------------------------------------------------------------------------------------------------
            Number                       Date                    Location                  Regulated area
----------------------------------------------------------------------------------------------------------------
                                 (a) Coast Guard Sector Delaware Bay--COTP Zone
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
17...........................  July 3rd, July 17th,      Metedeconk River, Brick   The waters of the Metedeconk
                                August 14th.              Township, NJ, Safety      River within a 500 yard
                                                          Zone.                     radius of the fireworks
                                                                                launch platform in
                                                                                approximate position
                                                                                latitude 40[deg]03'24'' N,
                                                                                longitude 074[deg]06'42'' W,
                                                                                near the shoreline at Brick
                                                                                Township, NJ.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

    Dated: June 24, 2014.
K. Moore,
Captain, U.S. Coast Guard, Captain of the Port Delaware Bay.
[FR Doc. 2014-15931 Filed 7-7-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 80 (Tuesday, April 26, 2022)]
[Notices]
[Page 24552]
[FR Doc No: 2022-08844]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2530-057]

Brookfield White Pine Hydro, LLC; Notice of Availability of Final
Environmental Assessment

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission)
regulations, 18 CFR part 380, the Office of Energy Projects has
reviewed the application for license for the Hiram Hydroelectric
Project, located on the Saco River in Oxford and Cumberland counties,
Maine, and has prepared a Final Environmental Assessment (FEA) for the
project. No federal land is occupied by project works or located within
the project boundary.
    The FEA contains the staff's analysis of the potential
environmental impacts of the project and concludes that licensing the
project, with appropriate environmental protective measures, would not
constitute a major federal action that would significantly affect the
quality of the human environment.
    The Commission provides all interested persons with an opportunity
to view and/or print the FEA via the internet through the Commission's
Home Page (http://www.ferc.gov/), using the ``eLibrary'' link. Enter
the docket number, excluding the last three digits in the docket number
field, to access the document. At this time, the Commission has
suspended access to the Commission's Public Reference Room, due to the
proclamation declaring a National Emergency concerning the Novel
Coronavirus Disease (COVID-19), issued by the President on March 13,
2020. For assistance, contact FERC Online Support at
[email protected], or toll-free at<PHONE_NUMBER>, or for TTY,
(202) 502-8659.
    You may also register online at https://ferconline.ferc.gov/FERCOnline.aspx to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    Any questions regarding this notice may be directed to John
Matkowski at<PHONE_NUMBER> or [email protected].

    Dated: April 20, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-08844 Filed 4-25-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 235 (Friday, December 10, 2021)]
[Notices]
[Pages 70503-70504]
[FR Doc No: 2021-26737]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1518]

Development of Anti-Infective Drug Products for the Pediatric
Population; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled
``Development of Anti-Infective Drug Products for the Pediatric
Population.'' The purpose of this guidance is to provide general
recommendations on the development of anti-infective drug products for
pediatric patients. The guidance addresses enrollment strategies,
extrapolation of efficacy, safety database, and other considerations to
help facilitate pediatric anti-infective drug product development. This
guidance finalizes the draft guidance of the same title issued on June
30, 2020.

DATES: The announcement of the guidance is published in the Federal
Register on December 10, 2021.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management

Staff, FDA will post your comment, as well as any attachments, except
for information submitted, marked and identified, as confidential, if
submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-1518 for ``Development of Anti-Infective Drug Products for
the Pediatric Population.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Hiwot Hiruy, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Development of Anti-Infective Drug Products for the
Pediatric Population.'' The purpose of this guidance is to provide
general recommendations on the development of anti-infective drug
products for pediatric patients. The guidance addresses enrollment
strategies, extrapolation of efficacy, safety database, and other
considerations to help facilitate pediatric anti-infective drug product
development.
    This guidance finalizes the draft guidance of the same title issued
on June 30, 2020 (85 FR 39193). FDA provided clarifying edits to the
final guidance and included additional information after considering
comments received on the draft guidance. Changes from the draft to the
final guidance include updates to efficacy extrapolation from adult to
pediatric patients (including from one pediatric subpopulation to
another), safety data collection, additional considerations for
studies, and recommendations for conducting juvenile toxicology
studies.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Development of Anti-Infective Drug
Products for the Pediatric Population.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR parts 312 and 314 and 21 CFR 201.56 and 201.57
have been approved under OMB control numbers 0910-0014, 0910-0001, and
0910-0572, respectively.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: December 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26737 Filed 12-9-21; 8:45 am]
BILLING CODE 4164-01-P